SlideShare a Scribd company logo

STR-324.pdf

P
phbordeau

STR-324 Non Opioid Pain Killer available for partnering

1 of 15
Download to read offline
24.11.2023
STR-324, A NATURAL NON-OPIOID
ANALGESIC DRUG CANDIDATE
3
The last decades, overprescription of opioids to manage chronic pain contributed to the
development of the current overdose epidemics.
New non-addictive therapies for effective pain management as viable alternatives to opioids
are urgently needed.
Physiological analgesia is a new paradigm in the treatment of pain. During a pain stress, the
human body release some endogenous peptides with analgesic properties including
enkephalins.
Unfortunately, all them quickly metabolized..
STR-324 is an endogenous pentapeptide able to inhibit enkephalin degrading enzymes.
Phase I and II studies have demonstrated that STR-234 is able to alleviate pain with an
excellent tolerance, no stimulating or dependence-like behaviors as conventional opioids do.
STR-324 is confirmed as a non-opioid pain therapy
2
• A product discovered at Pasteur Institute
– Pasteur Institute granted to Alaxia an exclusive worldwide license for the development of the asset for pain
management
• An endogenous product
– Highly stable synthetic equivalent of the endogenous human penta-peptide opiorphin
– Active only during painful situations
• Innovative mode of action
– Enkephalins are strong natural analgesic peptides that are quickly degraded by NEP and APN; STR-324 is
a dual inhibitor of NEP and APN
– By preserving enkephalins from degradation, STR-324 amplifies the duration of the physiological analgesic
action of enkephalins
• Demonstrated analgesia in the clinics with no major AE
– Phase I study in healthy volunteers demonstrates an excellent safety profile without CNS or GI adverse
events, commonly reported with opioids
– The exploratory Phase II study on post-operative pain demonstrates STR-324 induces analgesia and
confirms the lack of CNS or GI or any other major adverse events in the patients population.
STR-324 AT A GLANCE
4
MODE OF ACTION (presumed)
• STR-324 inhibits the enkephalin-degrading NEP and APN, thus increasing the bioactivity of enkephalins
• The magnitude of the nociceptive stimuli influences the amount of released enkephalins
• STR-324 activity depends on the amount of released enkephalins at the site of pain stimulus and during
the painful period
• The analgesic effect is abolished by the injection of naloxone, a nonselective opioid receptor antagonist
5
PRECLINICAL DATA – EFFICACY IN ANIMAL MODELS
Given as a continuous infusion, STR-324 provides long lasting analgesia in post-operative pain model
and reduces pain behavior in neuropathic pain model. Dose-effect profile is still to be determined
STR-324 has demonstrated high analgesic
potential with no cardiovascular or respiratory
adverse events in a rat model of post-operative
pain (Sitbon et al., 2016)
STR-324 reduces pain in rat model of neuropathic pain (van
Elstraete et. al., 2018)
6
PHARMACEUTICAL DEVELOPMENT
• Drug substance manufacturing process developed with Fmoc technology
• Drug substance is stable for minimum 60 months (ICH compliant)
• Drug product as a solution for injection is stable for minimum 48 months (ICH
compliant)
• Patches, liposomes and other long lasting product formulations under evaluation with
promising results

Recommended

SMi Group's Pain Therapeutics 2018 conference
SMi Group's Pain Therapeutics 2018 conferenceSMi Group's Pain Therapeutics 2018 conference
SMi Group's Pain Therapeutics 2018 conferenceDale Butler
 
Pain Therapeutics 2017
Pain Therapeutics 2017Pain Therapeutics 2017
Pain Therapeutics 2017Teri Arri
 
Palmitoylethanolamide in the Treatment of Neuropathic Pain
Palmitoylethanolamide in the Treatment of Neuropathic Pain Palmitoylethanolamide in the Treatment of Neuropathic Pain
Palmitoylethanolamide in the Treatment of Neuropathic Pain Sudhir Kumar
 
pharmacology practice school report.pptx
pharmacology practice school report.pptxpharmacology practice school report.pptx
pharmacology practice school report.pptxPharama slide share
 
pharmacologypracticeschoolreport-221219060301-1ca27004 (1).pdf
pharmacologypracticeschoolreport-221219060301-1ca27004 (1).pdfpharmacologypracticeschoolreport-221219060301-1ca27004 (1).pdf
pharmacologypracticeschoolreport-221219060301-1ca27004 (1).pdfManishJaat9
 
Pain management novel trends
Pain management   novel trendsPain management   novel trends
Pain management novel trendsHaripriya Uppala
 
Pain Informative Speech
Pain Informative SpeechPain Informative Speech
Pain Informative SpeechStefanie Yang
 

More Related Content

Similar to STR-324.pdf

Acute pain after surgery - lessons learned from the last decade - Stephan Sch...
Acute pain after surgery - lessons learned from the last decade - Stephan Sch...Acute pain after surgery - lessons learned from the last decade - Stephan Sch...
Acute pain after surgery - lessons learned from the last decade - Stephan Sch...scanFOAM
 
Pain management overview 2013
Pain management overview 2013Pain management overview 2013
Pain management overview 2013derosaMSKCC
 
Kartheek Dokka -Drug Trial that went wrong!
Kartheek Dokka -Drug Trial that went wrong!Kartheek Dokka -Drug Trial that went wrong!
Kartheek Dokka -Drug Trial that went wrong!Kartheek Dokka
 
Quality of life effects of Various Transdermal Pain Therapies including compo...
Quality of life effects of Various Transdermal Pain Therapies including compo...Quality of life effects of Various Transdermal Pain Therapies including compo...
Quality of life effects of Various Transdermal Pain Therapies including compo...Dr Manish Bansal Jacksonville Florida
 
Regulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property RightsRegulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property Rightssantoshnarla
 
Clinical reaserch 112070804001
Clinical reaserch 112070804001Clinical reaserch 112070804001
Clinical reaserch 112070804001Patel Parth
 
protocol 1 chetan final.pdf
protocol 1 chetan final.pdfprotocol 1 chetan final.pdf
protocol 1 chetan final.pdfmanojgandhi1
 
SMi Group's 14th annual Pain Therapeutics conference
SMi Group's 14th annual Pain Therapeutics conferenceSMi Group's 14th annual Pain Therapeutics conference
SMi Group's 14th annual Pain Therapeutics conferenceDale Butler
 
2010 nucynta core speaker slides
2010 nucynta core speaker slides2010 nucynta core speaker slides
2010 nucynta core speaker slidesLoubens Jean-Louis
 
Clinical reaserch 112070804001
Clinical reaserch 112070804001Clinical reaserch 112070804001
Clinical reaserch 112070804001Patel Parth
 
2011 passey treatment chronic pain
2011 passey treatment chronic pain2011 passey treatment chronic pain
2011 passey treatment chronic painworkcomp
 
10.30AM-Hayden - Research Presentation Update
10.30AM-Hayden - Research Presentation Update10.30AM-Hayden - Research Presentation Update
10.30AM-Hayden - Research Presentation UpdateHayden Isaacs
 
StimRouter PNS Brochure
StimRouter PNS BrochureStimRouter PNS Brochure
StimRouter PNS BrochureRegina Lefauve
 
INDClinicalStudyProtocol
INDClinicalStudyProtocolINDClinicalStudyProtocol
INDClinicalStudyProtocolLehel Simon
 

Similar to STR-324.pdf (20)

Acute pain after surgery - lessons learned from the last decade - Stephan Sch...
Acute pain after surgery - lessons learned from the last decade - Stephan Sch...Acute pain after surgery - lessons learned from the last decade - Stephan Sch...
Acute pain after surgery - lessons learned from the last decade - Stephan Sch...
 
clarity study
clarity studyclarity study
clarity study
 
NeuroSearch
NeuroSearchNeuroSearch
NeuroSearch
 
Jc 8
Jc   8Jc   8
Jc 8
 
UG THESIS SUPERVISION
UG THESIS SUPERVISIONUG THESIS SUPERVISION
UG THESIS SUPERVISION
 
Pain management overview 2013
Pain management overview 2013Pain management overview 2013
Pain management overview 2013
 
Kartheek Dokka -Drug Trial that went wrong!
Kartheek Dokka -Drug Trial that went wrong!Kartheek Dokka -Drug Trial that went wrong!
Kartheek Dokka -Drug Trial that went wrong!
 
Quality of life effects of Various Transdermal Pain Therapies including compo...
Quality of life effects of Various Transdermal Pain Therapies including compo...Quality of life effects of Various Transdermal Pain Therapies including compo...
Quality of life effects of Various Transdermal Pain Therapies including compo...
 
Regulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property RightsRegulatory affairs and Intellectual Property Rights
Regulatory affairs and Intellectual Property Rights
 
Clinical reaserch 112070804001
Clinical reaserch 112070804001Clinical reaserch 112070804001
Clinical reaserch 112070804001
 
protocol 1 chetan final.pdf
protocol 1 chetan final.pdfprotocol 1 chetan final.pdf
protocol 1 chetan final.pdf
 
Comparison of Clonidine, Dexmedetomidine and Tramadol for Control of Post Spi...
Comparison of Clonidine, Dexmedetomidine and Tramadol for Control of Post Spi...Comparison of Clonidine, Dexmedetomidine and Tramadol for Control of Post Spi...
Comparison of Clonidine, Dexmedetomidine and Tramadol for Control of Post Spi...
 
SMi Group's 14th annual Pain Therapeutics conference
SMi Group's 14th annual Pain Therapeutics conferenceSMi Group's 14th annual Pain Therapeutics conference
SMi Group's 14th annual Pain Therapeutics conference
 
2010 nucynta core speaker slides
2010 nucynta core speaker slides2010 nucynta core speaker slides
2010 nucynta core speaker slides
 
Clinical reaserch 112070804001
Clinical reaserch 112070804001Clinical reaserch 112070804001
Clinical reaserch 112070804001
 
Pain management in neurosurgical patients
Pain management in neurosurgical patientsPain management in neurosurgical patients
Pain management in neurosurgical patients
 
2011 passey treatment chronic pain
2011 passey treatment chronic pain2011 passey treatment chronic pain
2011 passey treatment chronic pain
 
10.30AM-Hayden - Research Presentation Update
10.30AM-Hayden - Research Presentation Update10.30AM-Hayden - Research Presentation Update
10.30AM-Hayden - Research Presentation Update
 
StimRouter PNS Brochure
StimRouter PNS BrochureStimRouter PNS Brochure
StimRouter PNS Brochure
 
INDClinicalStudyProtocol
INDClinicalStudyProtocolINDClinicalStudyProtocol
INDClinicalStudyProtocol
 

Recently uploaded

Population of India and Family welfare programme.pptx
Population of India and Family welfare programme.pptxPopulation of India and Family welfare programme.pptx
Population of India and Family welfare programme.pptxDr. Dheeraj Kumar
 
ABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdf
ABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdfABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdf
ABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdfAbdurahmanRafeeq
 
A complete guide to the Human Digestive System
A complete guide to the Human Digestive SystemA complete guide to the Human Digestive System
A complete guide to the Human Digestive Systemantoneymichael992
 
HEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studies
HEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studiesHEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studies
HEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studiesRichard Clement
 
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...leejalashrestha2
 
Impact of Early Pregnancy---Lecture-2024
Impact of Early Pregnancy---Lecture-2024Impact of Early Pregnancy---Lecture-2024
Impact of Early Pregnancy---Lecture-2024ERWINPEJI2
 
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...Subrata Roy
 
Introducing amazing Healthy habits and fitness
Introducing amazing Healthy habits and fitnessIntroducing amazing Healthy habits and fitness
Introducing amazing Healthy habits and fitnessFredrick Amos
 
Health powerpoint for catch -up fridays.
Health powerpoint for catch -up fridays.Health powerpoint for catch -up fridays.
Health powerpoint for catch -up fridays.JohnMarckySeoTeriomp
 
Artificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptx
Artificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptxArtificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptx
Artificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptxDr. Dheeraj Kumar
 
Autism and Savant Syndrome|Study|The Good doctor .pptx
Autism and Savant Syndrome|Study|The Good doctor .pptxAutism and Savant Syndrome|Study|The Good doctor .pptx
Autism and Savant Syndrome|Study|The Good doctor .pptxScripted Symptoms
 
ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.
ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.
ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.Divya Kanojiya
 
1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdf1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdfHongBiThi1
 
USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.
USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.
USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.vrchk912
 
Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.JULIANA BENAVIDES GUERRERO
 
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajTyphoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
SEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdf
SEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdfSEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdf
SEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdfmarlonduqueupb
 
Macquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPTMacquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPTMQ_Library
 
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajPoliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 
Tuberculosis .pptx Department of Physiotherapy, SHUATS, Prayagraj
Tuberculosis .pptx Department of Physiotherapy, SHUATS, PrayagrajTuberculosis .pptx Department of Physiotherapy, SHUATS, Prayagraj
Tuberculosis .pptx Department of Physiotherapy, SHUATS, PrayagrajSurabhi Srivastava
 

Recently uploaded (20)

Population of India and Family welfare programme.pptx
Population of India and Family welfare programme.pptxPopulation of India and Family welfare programme.pptx
Population of India and Family welfare programme.pptx
 
ABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdf
ABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdfABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdf
ABDULRAHMAN AL RAFIQ UPDATED MANAGEMENT OF ACUTE PULMONARY EMBOLISM .pdf
 
A complete guide to the Human Digestive System
A complete guide to the Human Digestive SystemA complete guide to the Human Digestive System
A complete guide to the Human Digestive System
 
HEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studies
HEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studiesHEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studies
HEPATIKA 6 Nutritional supplement, six ingredients supported by clinical studies
 
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
Bursitis is inflammation or irritation of a bursa sac. Bursae are small fluid...
 
Impact of Early Pregnancy---Lecture-2024
Impact of Early Pregnancy---Lecture-2024Impact of Early Pregnancy---Lecture-2024
Impact of Early Pregnancy---Lecture-2024
 
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
Work-role of Radiation Therapists in the Consequences of Adaptive Radiotherap...
 
Introducing amazing Healthy habits and fitness
Introducing amazing Healthy habits and fitnessIntroducing amazing Healthy habits and fitness
Introducing amazing Healthy habits and fitness
 
Health powerpoint for catch -up fridays.
Health powerpoint for catch -up fridays.Health powerpoint for catch -up fridays.
Health powerpoint for catch -up fridays.
 
Artificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptx
Artificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptxArtificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptx
Artificial Radionuclide Generators in Medicine Applications in Radiotherapy.pptx
 
Autism and Savant Syndrome|Study|The Good doctor .pptx
Autism and Savant Syndrome|Study|The Good doctor .pptxAutism and Savant Syndrome|Study|The Good doctor .pptx
Autism and Savant Syndrome|Study|The Good doctor .pptx
 
ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.
ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.
ANTI-HYPERTENSIVE DRUG - RAUWOLFIA ROOT.
 
1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdf1. GP Chi trên hay lạ khó cần xem nhiều.pdf
1. GP Chi trên hay lạ khó cần xem nhiều.pdf
 
USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.
USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.
USG,CT AND MR IMAGING OF HEPATIC MASS LESIONS.
 
Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.Seminario biologia molecular-Universidad Pontificia Bolivariana.
Seminario biologia molecular-Universidad Pontificia Bolivariana.
 
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, PrayagrajTyphoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
Typhoid.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
SEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdf
SEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdfSEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdf
SEMINARIO VIH BIOLOGIA MOLECULAR PDF.pdf
 
Macquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPTMacquarie Neurosurgery Journal Club 2022 PPT
Macquarie Neurosurgery Journal Club 2022 PPT
 
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, PrayagrajPoliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
Poliomyelitis.pptx Department of Physiotherapy, SHUATS, Prayagraj
 
Tuberculosis .pptx Department of Physiotherapy, SHUATS, Prayagraj
Tuberculosis .pptx Department of Physiotherapy, SHUATS, PrayagrajTuberculosis .pptx Department of Physiotherapy, SHUATS, Prayagraj
Tuberculosis .pptx Department of Physiotherapy, SHUATS, Prayagraj
 

STR-324.pdf

  • 1. 24.11.2023 STR-324, A NATURAL NON-OPIOID ANALGESIC DRUG CANDIDATE
  • 2. 3 The last decades, overprescription of opioids to manage chronic pain contributed to the development of the current overdose epidemics. New non-addictive therapies for effective pain management as viable alternatives to opioids are urgently needed. Physiological analgesia is a new paradigm in the treatment of pain. During a pain stress, the human body release some endogenous peptides with analgesic properties including enkephalins. Unfortunately, all them quickly metabolized.. STR-324 is an endogenous pentapeptide able to inhibit enkephalin degrading enzymes. Phase I and II studies have demonstrated that STR-234 is able to alleviate pain with an excellent tolerance, no stimulating or dependence-like behaviors as conventional opioids do. STR-324 is confirmed as a non-opioid pain therapy
  • 3. 2 • A product discovered at Pasteur Institute – Pasteur Institute granted to Alaxia an exclusive worldwide license for the development of the asset for pain management • An endogenous product – Highly stable synthetic equivalent of the endogenous human penta-peptide opiorphin – Active only during painful situations • Innovative mode of action – Enkephalins are strong natural analgesic peptides that are quickly degraded by NEP and APN; STR-324 is a dual inhibitor of NEP and APN – By preserving enkephalins from degradation, STR-324 amplifies the duration of the physiological analgesic action of enkephalins • Demonstrated analgesia in the clinics with no major AE – Phase I study in healthy volunteers demonstrates an excellent safety profile without CNS or GI adverse events, commonly reported with opioids – The exploratory Phase II study on post-operative pain demonstrates STR-324 induces analgesia and confirms the lack of CNS or GI or any other major adverse events in the patients population. STR-324 AT A GLANCE
  • 4. 4 MODE OF ACTION (presumed) • STR-324 inhibits the enkephalin-degrading NEP and APN, thus increasing the bioactivity of enkephalins • The magnitude of the nociceptive stimuli influences the amount of released enkephalins • STR-324 activity depends on the amount of released enkephalins at the site of pain stimulus and during the painful period • The analgesic effect is abolished by the injection of naloxone, a nonselective opioid receptor antagonist
  • 5. 5 PRECLINICAL DATA – EFFICACY IN ANIMAL MODELS Given as a continuous infusion, STR-324 provides long lasting analgesia in post-operative pain model and reduces pain behavior in neuropathic pain model. Dose-effect profile is still to be determined STR-324 has demonstrated high analgesic potential with no cardiovascular or respiratory adverse events in a rat model of post-operative pain (Sitbon et al., 2016) STR-324 reduces pain in rat model of neuropathic pain (van Elstraete et. al., 2018)
  • 6. 6 PHARMACEUTICAL DEVELOPMENT • Drug substance manufacturing process developed with Fmoc technology • Drug substance is stable for minimum 60 months (ICH compliant) • Drug product as a solution for injection is stable for minimum 48 months (ICH compliant) • Patches, liposomes and other long lasting product formulations under evaluation with promising results
  • 7. 7 STR-324 CURRENT PRECLINICAL DATA • Efficacy – Efficacy demonstrated in animal models of pain for post-operative and neuropathic pain • Safety pharmacology – No central nervous system, respiratory or cardiovascular adverse events were observed in rats or macaques. • Genotoxicity – In vitro and in vivo test demonstrate lack of genotoxic activity • General toxicology – No major toxicological findings were observed in rats or macaques at doses up to 280 times the target clinical dose
  • 8. First‐in‐human trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR‐324, a dual enkephalinase inhibitor for pain management Br J Clin Pharmacol. 2022 Jan; 88(1): 103–114. 8 PHASE I FIRST-IN-MAN STUDY • First-in-human, randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR- 324 in healthy subjects • Safety results – STR-324 was well tolerated at all tested doses in Parts I and II – No important risk identified, no potential risk identified in healthy volunteers • Pharmacodynamic results (Human models of pain) – Pain tests (Parts I and II) • Some positive analgesic trends observed on some pain tests – Cognitive tests – Potential off target effects (Part II only) • No CNS related opioid-like effects observed
  • 9. 9 PHASE IIA - POST OPERATIVE PAIN – STUDY DESIGN • Two parts study – Part I – Verification of the sensitivity of the study pain model in the proposed surgeries • Single blind group • N = 12 patients, three patients per surgery (abdominal, pelvic, total hip replacement and spine surgeries) • Clinical doses – Part II – Dose finding study • Randomized double blind parallel controlled group • N = 106 patients • Doses : 1.3 mg/h, 2.6 mg/h, 5.1mg/h, 10.2 mg/h of STR-324 or Morphine Group 1 Initial bolus + perfusion N = 40 STR-324 N = 13 morphine Group 2 Perfusion without bolus N = 40 STR-324 N = 13 morphine
  • 10. 10 PHASE IIA – POST-OPERATIVE PAIN – RESULTS A proof of concept randomized, double-blind, parallel group, controlled dose- finding and safety study of STR-324 in post-operative pain • Efficacy results – Primary endpoint: no statistically significant difference in the responder rates for STR-324 and morphine low dose groups – Secondary endpoints: similar response patterns between the treatment groups à similar time to maximum effect, similar intra-patient dose escalation pattern, similar rate of switch to standard pain management • Safety results – No serious adverse reaction attributed to STR-324 – No emerging safety concern, either serious or non-serious STR-324 can induce an analgesic effect in human – optimal mode of administration and treatment regimen are still to be defined STR-324 Clinical trial PhaseIIA results Publication submitted and accepted Publishing on the way
  • 11. 11 • Current IV formulation was designed to evaluate in the shortest time the analgesic properties of the lead • Preliminary results with other formulations demonstrated that: – Patches • STR-324 could be applied by patch using active transfer to avoid loss of product. Preliminary test demonstrated promising results with iontophoresis testing. This technology will increase permeability, stability and reduced Drug Substance needs in the final product. – Liposomal formulations • Tests using demonstrated that nanoprecipitated LPLG vesicles are the preferred preparation method with up to 60% of entrapment efficacy. FORMULATION
  • 12. 12 • Alaxia holds an exclusive world wide, sub-licensable license from Pasteur Institute to develop, commercialize • Three families of patents that protects: – The lead compound – Leas therapeutic applications – Lead derivatives and therapeutic applications • Patents granted in major markets (EU, USA, CA, AU…) • New Patents to come INTELLECTUAL PROPERTY
  • 13. 13 As demonstration of STR-324 efficacy has been done, development can be completed in order to use the product for wider range of pain indications such as pain in post-op, neuropathies, oncology,… Alaxia SAS, a French biotech company developing STR-324 is looking for partners to codevelop or to license out the asset as the company cannot carry on alone additional galenic developments and clinical trials. Alaxia is also open to new shareholders, at very interesting conditions. Don’t miss the opportunity, contact us at contact@bioalaxia.eu NEXT STEP
  • 14. 14 • First-in-human trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324, a dual enkephalinase inhibitor for pain management. Moss L, Berends C, Van Brummelen E, Kamerling I, Klaassen E, Bergmann K, Ville V, Juarez‐Perez V, Benichou AC, Groeneveld GJ, Br J Clin Pharmacol. 2022 Jan; 88(1): 103–114 • The Opiorphin Analog STR-324 Decreases Sensory Hypersensitivity in a Rat Model of Neuropathic Pain. Van Elstraete A, Sitbon P, Hamdi L, Juarez-Perez V, Mazoit JX, Benhamou D, Rougeot C. Anesth Analg. 2018 Jun;126(6):2102-2111. • Potent Opioid Analgesia without Respiratory Depression: Could It Be Possible? Dahan A. Anesthesiology. 2016. • STR-324, a Stable Analog of Opiorphin, Causes Analgesia in Postoperative Pain by Activating Endogenous Opioid Receptor-dependent Pathways. Sitbon P, Van Elstraete A, Hamdi L, Juarez- Perez V, Mazoit JX, Benhamou D, Rougeot C. Anesthesiology. 2016 Nov;125(5):1017-1029. • To be published • Influence of STR-324, a dual enkephalinase inhibitor, on postoperative pain scores: a proof-of- concept trial in patients following laparoscopic surgery. Van Dasselaar et al. Submitted to Anesthesiology. Scientific Publications
  • 15. 15