A proprietary natural product that is a candidate for drug development as a monotherapy and in combination with statins

Transcription

1 A proprietary natural product that is a candidate for drug development as a monotherapy and in combination with statins

2 HEP-40 Mechanism & Manufacturing Mechanism Manufacturing & Purification HEP-40 binds to fats and bile acids in the GI tract, forming an insoluble complex. This binding process prevents fats and lipids from being absorbed into the bloodstream as HEP-40 is insoluble. And because HEP-40 is hydrophilic, it becomes hydrated in the intestine and does not irritate the digestive tract. 2

3 HEP-40 Clinical Research 10 years of HEP-40 research 300 patients treated in 4 clinical studies Phase I: 8-week, double blind placebo controlled safety study - 83 volunteers demonstrated no serious side effects Phase I: 4-week open-label proof-of-concept study - 24 patients resulted in a mean 17% reduction in LDL cholesterol Phase II: Randomized, double-blind, placebo-controlled study patients exhibited clear dose-response ( grams/day) and a mean 17% reduction in LDL after 4 weeks* *Jaffer & Samplis, Efficacy and Safety of Chitosan HEP-40 in the Management of Hypercholesterolemia: A Randomized, Multicenter, Placebo-controlled Trial, Alt. Med. Review, 12:2007, ; references on file at DNP 3 Slide 3

4 HEP-40 Study Design With a Low Dose Statin 68 patients in 7 primary care centers in Canada Managed by a top CRO JSS Medical, Montreal, Quebec Inclusion criteria Patients on a statin no more than 6 months (average of 3 months), not controlled LDL levels not at target Rather than increasing dose, patients were randomized, given HEP-40 or placebo for 12 wks (double blind) HEP-40 group took 2.4g per day, 20 minutes before each meal (800mg capsules TID) Placebo group were given microcrystalline cellulose TID same capsule size Powered to show a 20% additional LDL reduction on top of statin therapy in the HEP-40 group, relative to placebo (p<0.05) 4

5 Phase II HEP-40 + Statin Results Results: HEP-40 was well-tolerated with side effects equal to placebo group (statins alone) HEP-40 + statin group experienced an additional 26% reduction in LDL cholesterol compared to statins alone (p=0.008) HEP-40 + statin group experienced an additional 34% reduction in triglycerides compared to statins alone (p=0.008) HEP-40 + statin group experienced a 17% drop in the TC : HDL ratio compared to statins alone (p=0.027) *performed by JSS Medical 5 Slide 19

6 HEP-40 + Statin Data was presented at the 2009 ACC Annual Meeting Phase II HEP-40/statin data was accepted for poster presentation at the 58 th Annual Scientific Session of the American College of Cardiology (ACC) in Orlando, Florida March 29 31, 2009 Abstract Efficacy and Tolerability of a Short Chain Polysaccharide (HEP-40) in the Management of Hyperlipidemia John S. Sampalis, Anthony Pellegrino, Nadia Longo, McGill University, Montreal, QC, Canada, JSS Medical Research Inc., Westmount, QC, Canada Slide 19 6

7 HEP-40 A Potentially More Potent, Safer Zetia Mechanism of Action: LDL drop in monotherapy: LDL drop on top of statins: Safety: Impact on CV Risk: 2008 Rx Sales: acts on dietary fats 11% to 17% 26% excellent profile none expected not absorbed none acts on dietary fats 10% to 18% 17% to 22% excellent profile conflicting evidence and uncertainty $4.5 Billion (Zetia + Vytorin) 7

8 HEP-40 Fills A Major Void Global statin sales exceeded $30 billion in 2008 while revenues are dropping, volumes continue to increase Vytorin s success is indication of doctors increasing desire to manage the dose dependent side effects of statins: Statin boosting: boost LDL reduction of statins without having to maximize dose of statin Statin-sparing: get cardiovascular benefits of statin with low dose, minimize side effects Patent expirations of most statins will create a promotional void in primary care, especially after 2011 (Lipitor expiry) Several natural to Rx switches have been approved by FDA: ABT s Niaspan and Simcor, GSK s Lovaza Slide 8