1. P12.01 - Efficacy and safety of topically applied 1.0% WBI-1001 for the
treatment of mild to moderate plaque psoriasis
Robert Bissonnette1
, MD, FRCPC, Chantal Bolduc1
, MD, FRCPC, Catherine Maari1
, MD, FRCPC,
Simon Nigen1
, MD, FRCPC, John Webster2
, PhD, Liren Tang2
, PhD, Michael Lyle2
, PhD
1
Innovaderm Research Inc., Montreal, QC, Canada, 2
Department of Research and Development,
Welichem Biotech Inc., Burnaby, BC, Canada
Learning Objective:
Understanding the efficacy and safety of a new experimental topical treatment for patients with
mild to moderate plaque psoriasis.
Take away message:
This phase IIa study suggests that WBI-1001 is an effective new treatment for mild to moderate
psoriasis.
Conflicts of interest:
Robert Bissonnette, Chantal Bolduc, Catherine Maari and Simon Nigen have been speakers,
consultants, advisory board members and/or investigators and have received honoraria and/or
grants from Welichem Biotech Inc., Abbott, Amgen, Astellas, Boehringer-Ingelheim, Celgene,
Centocor, Isotechnika, Janssen-Ortho, LeoPharma, Merck, Merck-Serono, Novartis, Pfizer.
Dr. Liren Tang is the President and CEO of Welichem Biotech Inc. Dr. John Webster is the Chief
Scientific Officer of Welichem Biotech Inc. Dr. Michael Lyle is the Vice President of Research and
Development of Welichem Biotech Inc.
Research funded and medication provided by Welichem Biotech Inc.
Contact details:
Innovaderm Research Inc. 1851 Sherbrooke Street East, Suite 502, Montreal, Quebec, H2K 4L5
Telephone: 514-521-4285
Fax: 514-906-0659
Email: rbissonnette@innovaderm.ca

2. Introduction – Materials and Methods
• Background
– Psoriasis is a chronic skin disorder with a
prevalence of up to 3%1
– The most commonly used topical treatments
for mild psoriasis are corticosteroids, vitamin D
and analogs and, to a lesser extent, tar2
– WBI-1001
• Novel non-steroidal anti-inflammatory
molecule
• Inhibits inflammatory cytokine
secretion by activated T-cells3
• Has been shown to improve atopic
dermatitis4
• Study Design
– Phase IIa double-blind, randomized and
placebo-controlled study
– Patients randomized (2:1) to:
• WBI-1001 1.0 % cream (bid )
• Placebo cream (bid)
– Patients were seen at Day 0, 14, 28, 42, 56 and
84
– Treatment duration: 84 days
• Rational and Objectives
– To evaluate the safety and the tolerability of
topical WBI-1001 at 1% for the treatment of
psoriasis
– To evaluate the efficacy of topical WBI-1001 at
1% for the treatment of psoriasis
• Study Population
– 60 patients,18-65 years of age
– Stable plaque psoriasis for ≥6 months
– BSA between 1% and 10% excluding the face,
groin, scalp, and genital region
– A minimum of one target psoriasis plaque that
was at least 2x2 cm at Day 0
– Physician’s global assessment (PGA) of
psoriasis score of 2 to 4 at Day 0
– No pustular, erythrodermic, or other non-plaque
forms of psoriasis
– No guttate psoriasis as the dominant form of
psoriasis

3. Materials and Methods - continued
• Study Procedures
– Day 0:
• Randomization to WBI-1001 1% or
placebo group
– Every visit:
• Efficacy evaluations (PGA5
, PASI6
, BSA,
target lesion assessments)
• Laboratory tests (hematology, chemistry
and urinalysis)
• Adverse event and concomitant
medication collection
– Day 0, 28, 56 and 84:
• Photograph of target lesion
– Screening and Day 84:
• 12-lead ECG
– From Day 14:
• Study cream compliance evaluation
• Endpoints
– Primary endpoint: change from baseline (Day 0)
in PGA at Day 84
– Proportion of patients who achieved a PGA score
of 0 or 1 at Day 84
– Change from baseline in PASI, BSA and target
lesion assessments (erythema, induration, scaling
and target lesion severity at Day 84
– Proportion of patients who achieved a 50%
improvement in PASI from baseline (PASI 50) at
Day 84
– Proportion of patients who achieved a 75%
improvement in PASI from baseline (PASI 75) at
Day 84
– Type, frequency, severity and relationship of
adverse events
• Post-hoc analysis
– Proportion of patients who achieved a PGA score of 0 or 1 over time with at least 2-grade PGA improvement

4. Results - Efficacy
Significant difference between WBI-1001 and placebo observed as early as Day 14 for mean change form baseline in
PGA, BSA, PASI and target lesion severity (p<0.0001, p=0.0273, p=0.001 and p=0.0008 respectively)
Psoriasis severity
• Primary endpoint: mean change from baseline in
PGA at Day 84: -2.0 (-62.5%) for WBI-1001 vs -0.5 (-
14.2%) for placebo, p<0.0001.
• Mean change from baseline in BSA at Day 84: -2.6
(-79.1%) for WBI-1001 vs +0.3 (+9.4%) for placebo,
p<0.0001.
• Proportion of patients with PASI 50 at Day 84:
72.5% (WBI-1001) vs 9.5% (placebo), p <0.0001.
• Proportion of patients with PASI 75 at Day 84:
50.0% (WBI-1001) vs 4.8% (placebo), p=0.0004.

5. Results
• Safety
– All non-dermatological adverse events were
evaluated as not related to the study treatment
– Two patients discontinued because of an
application site contact dermatitis.
– One serious adverse event reported:
Cerebrovascular accident (placebo group), not
related to study treatment
– No clinically significant abnormal ECG or
laboratory results
1% WBI-1001
(N=40)
placebo
(N=21)
Adverse event with incidence
≥ 5%
Number of
patients (%)
Number of
patients (%)
Nasopharyngitis 15 (37.5) 6 (28.6)
Application site
discolouration
(hyperpigmentation)*
11 (27.5) 0 (0.0)
Application site folliculitis* 4 (10.0) 0 (0.0)
Application site dermatitis* 6 (15.0) 0 (0.0)
Abdominal pain 3 (7.5) 0 (0.0)
Application site papules* 3 (7.5) 0 (0.0)
Application site pain* 2 (5.0) 1 (4.8)
Application site pruritus* 2 (5.0) 0 (0.0)
Pruritus** 2 (5.0) 0 (0.0)
Contact dermatitis 2 (5.0) 0 (0.0)
Dry skin 2 (5.0) 0 (0.0)
Back pain 2 (5.0) 2 (9.5)
Headache 2 (5.0) 1 (4.8)
AE: Adverse event
*Treatment-related AEs
** Treatment-related AE for only one of the two subjects
1% WBI-1001
(N=40)
Placebo
N=21)
Number of
AEs
Suspected
Not
suspected
Suspected
Not
suspected
Mild 34 35 0 21
Moderate 2 7 0 2
Severe 0 0 1 1

6. Results
WBI-1001 group
Baseline Day 28 Day 56 Day 84
Baseline Day 28 Day 56 Day 84
Placebo group
• Photographs of representative psoriasis plaques on the elbow (WBI-1001) and
knee (placebo)

7. Conclusions
– Efficacy:
• WBI-1001 is effective in improving mild to moderate plaque psoriasis.
• Primary endpoint was met: mean change from baseline in PGA at Day 84: -2.0 (-62.5%) for
WBI-1001 vs -0.5 (-14.2%) for placebo, p<0.0001.
• WBI-1001 has a rapid onset of action as shown by significant improvement observed as
early as Day 14
• Improvements observed were in the same order of magnitude as what has been previously
published for potent topical corticosteroids
– Safety:
• No significant difference between patients randomized to placebo and to WBI-1001 in non
dermatological adverse events.
• All adverse drug reactions observed in patients randomized to WBI-1001 were either mild
(34) or moderate (2) in intensity and included hyperpigmentation, contact dermatitis and
folliculitis.
References:
1. Greaves MW, Weinstein GP. Treatment of psoriasis. N Engl J Med 1995; 332:581–588.
2. Bos JD, Spuls PI. Topical treatment in psoriasis: today and tomorrow. Clin Dermatol 2008;26:432-437.
3. Data on file at Welichem Biotech Inc, Burnaby, British Columbia, Canada.
4. Bissonnette R, Chen G, Bolduc C, Maari C, Lyle M, Tang L, Webster J and Zhou Y. Efficacy and Safety of Topical
WBI-1001 in the Treatment of Atopic Dermatitis: Results From a Phase 2A, Randomized, Placebo-Controlled
Clinical Trial. Arch Dermatol. 2010;146:446-449.
5. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2006;64:65-68.
6. Feldman SR, Fleischer AB Jr, Reboussin DM et al. The self-administered psoriasis area and severity index is valid
and reliable. J Invest Dermatol 1996;106: 183-186.
• WBI-1001 safety and efficacy