Ventrus (VTUS): Hemorrhoid Drug-309- PIIb hits its Primary Endpoint

Last week Ventrus Biosciences (NASDAQ: VTUS) reported that the final results from its PIIb study of VEN 309 (Iferanserin ointment) for the treatment of internal hemorrhoid disease (HD) were published. This study was conducted in Europe (Germany) and was randomized, double-blind, t=14-day placebo-controlled trial evaluating the efficacy and tolerability of BID (twice-daily) VEN 309 for the cessation of bleeding and other symptoms associated with Hemorrhoids.

The study hit its primary endpoint demonstrating efficacy and safety. The primary efficacy endpoints was a severity scores for bleeding on days 7 & 14. Secondary efficacy endpoints were itching, pain and other related symptoms also on day 7 & 14. The study was well powered at n= 111 patients split between control (placebo) and active VEN 309 groups.

VEN 309 was associated with a statisically significant reduction in daily bleeding &  itching on both days seven and 14 (bleeding, p<0.0001 and p=0.0075, respectively; itching, p=0.0008 and p=0.027, respectively). In terms of pain relief the data showed a favorable trend but was not statisically significant. Given that this is a Phase II trial and not a Phase III trial we are not concerned, a larger Phase III (P3 n=600) should add enough pwer to see a significant result. 

VEN 309 is on track to be the first new treatment (FDA Approved) for hemorrhoids. VEN 309 is in a Phase 3 trial now with top-line results expected this spring to summer. 

Ventrus Biosciences (NASDAQ: VTUS) works to provide prescription alternatives for treatment of gastrointestinal disorders

Ventrus Biosciences (NASDAQ: VTUS) is a development stage specialty pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoids, anal fissures and fecal incontinence.

Last week, Ventrus announced that S.L.A. Pharma (Private), its EU partner, is ahead of schedule and has completed enrollment in the first of two pivotal Phase III studies with Diltiazem (VEN 307) for the treatment of anal fissures. Diltiazem is an off-label calcium channel blocker that is commonly used to treat anal fissures. 

Although Diltiazem has been shown to be effective, it remains difficult for consumers to access. Because it is off-label, patients need to find a special pharmacy that can make it, which is a hassle for pharmacies, doctors and patients. 

Ventrus hopes to resolve the situation by bringing a quality controlled, clinically trial proven product to the market. Avoiding surgery and having a prescription (ie, reimbursed) alternative is a genuine patient need.

The company’s other lead product is VEN 309, Iferanserin. This product, like VEN 307, is a topical treatment for hemorrhoids. The first Phase III trial started in August 2011 and top-line data is expected in June 2012. VEN 309 can be thought of as a prescription alternative to Preparation H, an over-the-counter cream.

Given that an increased risk of hemorrhoids is yet another consequence of leading a sedentary lifestyle, the market opportunity for a new Rx product for hemorrhoids is significant.

Coronado: CNDO - Makes the NASDAQ

Coronado began trading on the NASDAQ as CNDO, and was off in its first day of trading, $6 (down $0.50). Coronado is a fascinating story in immunology on two fronts, on the cell therapy side with an NK cell that rebuilds patients immunity and the other product CNDO-201 is a "whip worm" product. Normally we would consider this a parasite but in this case, the ova from the porcine helminth Trichuris suis may work symbiotically in man, to help re-balance out of balance "auto-immune" system. A phase IIb trial is scheduled to begin in 1Q-2012 to treat Crohn's disease patients but the implications here could reach as far as Multiple Sclerosis (MS).

Please see our write-ups here on Daily Dose and also on the ProActive Coronado page. We know that National Securities and their army of 750 retail brokers helped raise the initial capital, (as they did for Ventrus -VTUS) last year to bring this company public. As of September, the company has $26.7 million in cash. Coronado starts trading with a strong retail following as management now works to create an institutional following.