Innovation Pharmaceuticals Inc. · OTC:IPIX
Innovation Pharmaceuticals — Medical Dermatology Therapeutic R&D and Technical Innovation Workshop 2016
16 slides from Innovation Pharmaceuticals's conference presentation, Nov 30, 2017
Slide 1: Prurisol: A New Small Molecule under investigation for the treatment of Psoriasis
Prurisol: A New Small Molecule under investigation for the treatment of Psoriasis Krishna Menon, RCM, PhD, VMD, President of Research and Chief Scientific Officer MEDICAL DERMATOLOGY THERAPEUTIC R&D AND TECHNICAL INNOVATION Boston, MA 19September 2016 Disclosure: full-time employee of Cellceutix 1 1
Slide 2: Psoriasis: Debilitating Chronic Disease That Affects Millions
Psoriasis Debilitating Chronic Disease That Affects Millions 84% of those with moderate-to-severe psoriasis report suffering discrimination and humiliation Sources: https://www.novartis.com/news/media-releases/largest-global-psoriasis-survey-shows-84-people-face-discrimination-and http://www.cythera
Slide 3: Prurisol MOA and Attributes
Prurisol MOA and Attributes Mechanism of Action (MOA) • Nonclinical data: Acts through immune modulation and PRINS* reduction • Reduces IL-20 • Reduces skin cell proliferation rate Attributes • Strong Intellectual Property(IP) and patent protections • Small-molecule (<500 MW) (an ester of abacavir)
Slide 4: Mouse Psoriasis Model: Comparison with Ziagen (Abacavir)
Prurisol Mouse Psoriasis Model: Comparison with Ziagen® (Abacavir) • BALB/C mice treated daily with IMQ cream or control cream on the back of the animal close to the tail • 16 days of treatment; assessed every 2nd day for erythema, scales and thickness; Scale 0 to 4 • Calculated a cumulative score o
Slide 5: Human Psoriatic Xenograft Model: PRINS & IL-20
Prurisol Human Psoriatic Xenograft Model: PRINS & IL-20 * • Human psoriatic skin xenograft model; SCID mice received 350 rad total body irradiation, then transplanted with psoriatic human tissue • Four groups: • 10 mg/kg Prurisol orally once per day for 21 days • 10 mg/kg Prurisol orally twice per d
Slide 6: Prurisol Bioequivalence Trial
CTIX-0001 Prurisol Bioequivalence Trial Single-Dose, Crossover Pharmacokinetic and Bioequivalence Study Evaluating Oral Prurisol** and Oral Abacavir Sulfate (Ziagen®) in Healthy Volunteers • AUC values were comparable for both Prurisol and Ziagen, within 80% to 125% equivalence window, indicating eq
Slide 7: CTIX-0002 Proof of Concept Trial Design
CTIX-0002 Proof of Concept Trial Design Primary efficacy endpoint: percentage of subjects with ≥ 2 point improvement in IGA rating at 84 days (12 weeks) Investigator Global Assessment (IGA) rating: clear (0), almost clear (1), mild (2), moderate (3), severe (4), very severe (5) • Randomized, double
Slide 8: CTIX-0002 Disease Burden Entry Criteria
CTIX-0002 Disease Burden Entry Criteria Individuals with mild-to-moderate chronic plaque psoriasis • Clinical diagnosis of stable (at least 6 months) plaque psoriasis, not including scalp or intertriginous areas • Body surface area (BSA) affected by plaque psoriasis of 10% to 20% inclusive • Investi
Slide 9: CTIX-0002 Subject Demographics
CTIX-0002 Subject Demographics Characteristics at Baseline were similar for all 4 treatment groups ITT Population Prurisol 50 mg Prurisol 100 mg Prurisol 200 mg Placebo Baseline Characteristic (N=29) (N=28) (N=28) (N=30) Age (years), Mean (SD) 57.7 (11.11) 55.2 (13.55) 56.9 (15.02) 55.9 (11.25) Male
Slide 10: Primary Efficacy Endpoint: ≥ 2-point improvement in IGA
CTIX-0002 Primary Efficacy Endpoint (Percentage of Subjects ≥ 2-point improvement in IGA at Week 12) At Week 12 (200 mg group), 25.9% subjects (ITT) and 35.0% subjects (PP) achieved ≥ 2-point improvement in IGA Prurisol 200 mg Placebo Week 12 Analysis ITT population n/N1, (%) 7/27 (25.9) 4/30 (13.3)
Slide 11: ≥ 2-point Improvement in IGA Over Time
CTIX-0002 ≥ 2-point Improvement in IGA Over Time • Clinical improvement observed in 200 mg group as early as 4 weeks • ≥ 2-point IGA improvement (200 mg group) at Week 12 was 25.0% subjects (ITT) and 35.0% subjects (PP) * Source: Table 14.2.1.2.3 (ITT Population) Source: Table 14.2.1.2.4 (PP Populat
Slide 12: IGA Scores: Distribution Over Time (200 mg group)
CTIX-0002 IGA Scores: Distribution Over Time (200 mg group) • IGA changes noted as soon as Week 2 • Progressive decrease of IGA scores to lower values over 12 weeks • At Week 12, 42.8% subjects (ITT) and 55.0% subjects (PP) achieved “clear” (0) or “almost clear” (1) in IGA * Source: Table 14.2.1.2.1
Slide 13: Safety Summary: Generally Well Tolerated
CTIX-0002 Safety Summary: Generally Well Tolerated • Adverse Events For the Prurisol dose groups combined: • Headache was the most frequently reported AE (6 AEs, 7.1%) • One Serious Adverse Event (preferred term “hepatic enzyme increased”) reported in 50 mg dose group • Liver function test increases
Slide 14: Pharmacokinetics of Abacavir
CTIX-0002 Pharmacokinetics of Abacavir Dose-related increase in exposure and plasma concentrations observed Mean ± SE plasma concentrations of abacavir • Comparable plasma concentrations expected for 700 Linear Axes 1000 S emi-Logarithmic Axes 50 mg AM and 50 mg AM & PM doses due to 600 Abacavir Con
Slide 15: Current Perspectives: Looking Forward
Current Perspectives Looking Forward • The primary efficacy endpoint of percentage of subjects with ≥ 2-point improvement in IGA was met with the 200 mg Prurisol dose group achieving highest magnitude of effect • A clear progressive decrease of IGA scores to lower values was seen as early as 2 weeks
Slide 16: Cellceutix Corporation
Cellceutix Corporation 100 Cummings Center, Suite 151B Beverly, MA 01915 Ticker: CTIX 16