Dynogen presents results of its positive Phase 2 IBS-d study with DDP225

Dynogen presents results of its positive Phase 2 IBS-d study with DDP225

Dynogen Pharmaceuticals, Inc. announced today the presentation of positive results from its Phase 2a trial of DDP225 in patients with irritable bowel syndrome with diarrhea (IBS-d) at the Digestive Disease Week 2008 (DDW) scientific meeting. The randomized, double-blind, placebo controlled trial established clinical proof-of-concept with statistically significant results for the endpoint of relief of abdominal pain or discomfort associated with IBS-d. Dynogen previously reported top-line results from this Phase 2a trial in December 2007. The DDW abstract was co-authored by Dynogen and a team of investigators from leading clinical centers in Canada. The DDP225 results were presented yesterday in a Distinguished Abstract Plenary session on Neurogastroenterology and Motility by Steven B. Landau, M.D., a member of Dynogen’s Scientific Advisory Board.

Dynogen expands DDP225 patent estate

Dynogen Pharmaceuticals, Inc. today announced that the Company has acquired from Arachnova Therapeutics, Ltd. all of its worldwide patent rights and know- how related to DDP225 in an asset purchase agreement. The Arachnova patent rights, which include granted patents and pending applications related to the use of DDP225 for the treatment of functional bowel disorders, genitourinary (GU) disorders and pain, complement and enhance Dynogen’s existing extensive worldwide patent estate related to DDP225. Financial terms of the agreement were not disclosed.

Dynogen announces positive results in Phase 2 IBS-d study

Dynogen Pharmaceuticals, Inc. today announced positive results from its Phase 2 trial of DDP225 in patients with irritable bowel syndrome with diarrhea (IBS-d). The randomized, double-blind, placebo controlled trial generated statistically significant results for the clinical endpoint of relief from abdominal pain or discomfort associated with IBS-d. Detailed results will be submitted for disclosure in a peer-reviewed journal or at a future medical conference.

Dynogen begins Phase 2b trial for IBS with constipation drug

Dynogen Pharmaceuticals, Inc. announced today that the first patients have been dosed in a Phase 2b trial of DDP733 (pumosetrag) as a treatment for irritable bowel syndrome with constipation (IBS-c). This DDP733 Phase 2b trial is a randomized, double-blind, placebo controlled study that is enrolling female patients with IBS-c at multiple centers in the U.S. and Canada. The study is assessing efficacy using the Overall Subject Global Assessment (OSGA) of relief of IBS symptoms, as well as the safety and tolerability of the drug.

Dynogen announces the presentation of its positive Phase 1b trial results at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Philadelphia, PA

Dynogen Pharmaceuticals, Inc. announced the presentation of its positive Phase 1b trial results for its DDP733 (pumosetrag) nocturnal gastroesophageal reflux disease (NGERD) program at the American College of Gastroenterology Annual Scientific Meeting (ACG) in Philadelphia, PA. The randomized, double-blind, placebo-controlled study demonstrated proof-of- concept and overall safety and tolerability of DDP733 in reducing reflux events. The ACG abstract was authored by researchers from the Mayo Clinic and Dynogen. The DDP733 results were presented on October 14, 2007 during a poster session.

Dynogen reports positive results in Phase 2 IBS-c study

Dynogen Pharmaceuticals, Inc. today reported positive results of its randomized, double-blind, placebo–controlled, parallel group Phase 2 trial of DDP733 in patients with irritable bowel syndrome with constipation (IBS-c). DDP733 achieved an overall clinical response rate of 54% in patients receiving a dose of 1.4 mg t.i.d. compared to a 15% clinical response rate for patients receiving placebo. This was a statistically significant difference in a clinical endpoint which has been accepted by the FDA as a registration endpoint for this indication. The drug was well tolerated in this study. Detailed results will be submitted for disclosure in a peer-reviewed journal or at a future medical conference.

Dynogen initiates phase 1b trial of DDP733 in gastroesophageal reflux disease (GERD)

Dynogen Pharmaceuticals, Inc. announced today that dosing has begun for a double-blinded, placebo controlled Phase 1b trial designed specifically to examine DDP733 on the functional changes associated with gastroesophageal reflux. In addition to examining safety, the trial will be powered to yield important efficacy data to support the use of DDP733 as a treatment for nocturnal gastroesophageal reflux (NGERD). Dynogen is developing DDP733 for NGERD as an adjunctive treatment with current GERD therapies. DDP733 is also being studied by Dynogen for irritable bowel syndrome with constipation (IBS-c) in a Phase 2 clinical study.

Dynogen Initiates Phase II Trial of Ddp225 for Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome

Dynogen Pharmaceuticals, Inc. announced today that it has initiated a Phase II proof-of-concept trial of DDP225 for diarrhea-predominant irritable bowel syndrome (IBS-d), and the first patients have been dosed. DDP225 is an orally-active compound that targets two key pathways that control the gastrointestinal (GI) system, thus giving it the potential to address multiple symptoms associated with IBS-d. This DDP225 Phase II trial is a randomized, double-blind, placebo controlled study that is enrolling patients with IBS-d at multiple centers in Canada and is assessing safety and pharmacodynamic efficacy as well as symptom-based endpoints. In September 2005, Dynogen began dosing patients in a Phase II study of DDP733 for the treatment of patients with constipation-predominant IBS (IBS-c), the other common form of IBS.