PurGenesis Technologies Reports Excellent Safety and Biological Activity From a 2-Week Phase IIa Proof of Concept Clinical Trial With PUR 0110 for the Treatment of Ulcerative Colitis
- Clean safety profile: no treatment-related adverse events, serious adverse events or withdrawals due to adverse events
- Objective evidence of biological activity: rapid onset and marked reductions in the levels of leukotriene B4, C-reactive protein, CRP, hs-CRP and other standard biomarkers of active inflammation
- Positive trends toward improvement in the key symptoms of ulcerative colitis
- On-going data analyses with a full report expected in the fall of 2013
MONTMAGNY, QC, Aug. 6, 2013 /CNW Telbec/ - PurGenesis Technologies Inc. (PurGenesis), the leading Canadian botanical pharmaceutical company, announced positive preliminary results from the Phase 2a clinical study with its lead drug candidate PUR 0110. This study is positive news from the first proof of concept clinical trial conducted by PurGenesis, a development stage company, which has products under development for Ulcerative Colitis, Psoriasis, Atopic Dermatitis and a line of cosmeceutical anti-aging products.
The study was a 2-week exploratory, multicenter, randomized, double-blind, parallel-group, dose-ranging, placebo-controlled safety, tolerability, biomarker and efficacy clinical study of PUR 0110 rectal enema in 24 patients with active mild-to-moderate distal ulcerative colitis. Assessments were performed at Weeks 1 and 2, and 1 week after the end of treatment (Week 3).
The primary objective of the study was to evaluate the safety and tolerability of 250 mg, 500 mg and 1000 mg PUR 0110 rectal enema administered once-daily versus placebo. The secondary objective was to assess its biological activity through its biomarker effects.
The proof-of-concept study met the primary endpoint as PUR 0110 was safe and well tolerated. No serious adverse events, treatment-related adverse events or withdrawals due to adverse events were reported. These results are consistent with the results of a previous Phase 1 study in normal healthy volunteers where 187.5 to 1500 mg doses of PUR 0110 rectal enema were safely and tolerably administered, a maximum tolerated dose was not observed.
At Week 2, the PUR 0110 250 mg treatment induced rapid, marked and consistent reductions in the level of biomarkers of active inflammation: C-reactive protein (CRP; -48.0%) and high sensitivity CRP (hs-CRP; -52.5%) levels (biomarkers of systemic inflammation); erythrocyte sedimentation rate (ESR; -29.0%), fecal calprotectin (FC; -41.5%) and fecal lactoferrin (FL; -63.6%) (biomarkers for bowel inflammation), compared to increases of 18.8% to 120.5% for placebo. At week 3, there were either further reductions to -77.6% (CRP), -80.9% (hs-CRP) and -82.9% (FL) or the reductions were maintained. Similar reductions were observed for the PUR 0110 1000 mg treatment for other biomarkers including: ESR, FC and FL. In addition, at Week 2, serum leukotriene B4 (LTB4) levels were reduced by the PUR 0110 treatments (250 mg: -31.4%; 500 mg: -28.0%; and 1000 mg: -22.2%) with further reductions at Week 3 to -85.0% (250 mg) and -46.9% (500 mg) or the reduction was maintained (1000 mg). These reductions in the established biomarkers of active inflammation, which started at Week 1, are objective evidence of the biological activity of PUR 0110 on the intestinal inflammation in ulcerative colitis. The reductions in serum LTB4 levels are consistent with the results of previous animal pharmacology studies that demonstrated PUR 0110 reduces the production and release of lipid mediators of inflammation, including prostaglandins and leukotrienes.
In addition, the preliminary results showed notable trends towards the superiority of PUR 0110 over placebo at Week 2 and included: patient-defined remission (250 mg 50% vs. 20% placebo); placebo-adjusted improvements of approximately 1-point each, corresponding to a shift from moderate symptom severity at baseline to mild at week 2, for stool frequency (1000 mg) and rectal bleeding (250 mg and 500 mg) by the modified Mayo sub-scores; and also for the total score, and diarrhea, rectal bleeding and abdominal pain sub-scores (500 mg) of the investigator's assessment of ulcerative colitis symptom score. These results suggest PUR 0110 has activity against the disease process in active mild-to-moderate distal ulcerative colitis. The analysis of the study data is on-going.
"Despite the short duration of the study, the rapid onset and marked reductions in the biomarkers of active inflammation observed, the emerging excellent safety profile along with the positive trends toward the relief of the key symptoms of ulcerative colitis are strong indicators of the potential clinical value of PUR 0110," stated Dr Theo Gana, MD, PhD, clinical consultant to the company. "These are great results and establish the feasibility of conducting a larger Phase IIb / Phase III study with a longer duration of treatment" added Dr Gana.
"The successful completion of this first proof of concept study in humans is a major milestone for our Company" added Dr Andre P. Boulet, PhD, President and COO of PurGenesis Technologies Inc.
"I am very pleased with the progress being made at PurGenesis and look forward to extending this recent success to further clinical development in a variety of areas. The pharmaceutical industry requires perseverance and commitment - especially when addressing such large potential markets" stated Eugene Melnyk, The Chairman and largest shareholder, who also is the largest shareholder of Trimel Pharmaceuticals (TSX: Symbol TRL).
About Ulcerative Colitis
Ulcerative colitis (UC) is one of the 2 major types of inflammatory bowel disease (IBD), along with Crohn disease. Unlike Crohn disease, which can affect any part of the gastrointestinal (GI) tract, UC characteristically involves the large bowel. It typically first appears in men or women between the ages of 15 and 40, but occasionally this condition first occurs in people in their 60s. Signs and symptoms include bloody diarrhea, abdominal cramping and pain on the left side, and unintended weight loss. The course of ulcerative colitis varies, with periods of acute illness often alternating with periods of remission. The highest annual incidence of UC has been reported to be 24.3 per 100,000 person-years in Europe, 6.3 per 100,000 person-years in Asia and the Middle East, and 19.2 per 100,000 person-years in North America. It is expected that sales of medications to treat ulcerative colitis in seven key markets will double over the next decade, reaching $3.7 billion by 2021.
About PUR0110
PUR0110, the first pharmaceutical product issued from PurGenesis' SUPREXTM platform is a highly innovative product to be used in the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, psoriasis, rheumatoid arthritis, skin aging, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of PUR0110 have been demonstrated by an impressive number of in vitro and in vivo studies. PUR0110 is currently under development for ulcerative colitis and Psoriasis. Both PUR0110 and SUPREXTM platform are protected by several patents in North America, Europe and Asia.
About PurGenesis Technologies Inc.
PurGenesis is a privately-held, leading Canadian Botanical Pharmaceutical Company that uses novel therapeutic approaches to develop highly promising therapies for significant markets with unmet medical needs. The company is developing novel botanical therapies to treat human inflammatory diseases. PurGenesis' lead product is PUR0110, a new investigational botanical drug product that incorporates proprietary, extraction processes of a supra-molecular complex with strong anti-inflammatory effects with applications in multiple therapeutic areas. The company is also developing anti-aging and sun care products for the cosmeceutical market.
SOURCE: PurGenesis Technologies
Brian Crombie,
CFO and Corporate Business Development
416-409-5102
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