Navigation Links
Dynogen Reports Positive Results in Phase 1B GERD Study

WALTHAM, Mass.--(BUSINESS WIRE)--Jun 7, 2007 - Dynogen Pharmaceuticals, Inc. reported positive results of its randomized, double-blind, placebo-controlled Phase 1b trial of DDP733 for gastroesophageal reflux disease (GERD). The study was designed to demonstrate proof-of-concept for DDP733 as a treatment for nocturnal GERD (NGERD). The 0.5 mg dose of DDP733 achieved statistical significance over placebo on the primary endpoint of reduction in the number of reflux events and was safe and well tolerated. Dynogen is planning to initiate a Phase 2 study of DDP733 in GERD patients in 2008.

DDP733 is an oral, partial agonist of the serotonin type 3 receptor (5-HT(3)), which Dynogen is developing for gastrointestinal conditions such as GERD and irritable bowel syndrome with constipation (IBS-c). In this translational medicine study, healthy volunteers were given a high fat meal to induce gastroesophageal reflux. Reflux events were measured by intraesophageal impedance (the electrical resistance that provides insight into the height and duration of a reflux episode).

"With this second set of positive proof-of-concept data for DDP733, following closely on the heels of our positive Phase 2 data for DDP733 in irritable bowel syndrome with constipation, we've unlocked the potential of this compound as a treatment for two distinct and underserved GI disorders," said Lee R. Brettman, M.D., Chief Executive Officer at Dynogen. "We estimate the peak sales for these indications to be in excess of a billion dollars each, reflecting the significant unmet medical need represented by these disorders. Dynogen has the opportunity to make a real difference in the quality of life of many patients suffering from these disorders."

"We designed this study with the dual goals of obtaining an indication of efficacy and establishing appropriate doses for our later-stage clinical study, and I am pleased to say we accomplished both ," said Dr. Suhail Nurbhai, MRCP, Vice President of Clinical Development at Dynogen. "DDP733, which targets the GI motility abnormalities central to GERD, has demonstrated a statistically significant reduction in the number of reflux events at a dose of 0.5 mg in this trial. We are now planning a larger Phase 2 study in GERD patients, where we will further build on these very promising results."

In February of this year, Dynogen announced positive results from its Phase 2 study of DDP733 in IBS-c, with a statistically significant improvement over placebo in the Subject Global Assessment of IBS. The Company plans to initiate a Phase 2b study in IBS-c this year.

About DDP733

DDP733 is an oral, partial agonist of the serotonin type 3 receptor (5-HT(3)). Serotonin is a neurotransmitter that is known to be involved in the control of the gastrointestinal (GI) system. Preclinical studies of DDP733 established the compound's prokinetic properties (the ability to promote the motility of the GI tract). Dynogen's preclinical studies have also shown that DDP733 is minimally absorbed by the cells lining the gastrointestinal tract and, as a result, more of the product candidate remains available at the desired local site of action. A recently completed Phase 2 study of the candidate as a treatment for IBS-c demonstrated 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, and the drug was also well-tolerated. Previous clinical studies of the compound have demonstrated favorable safety and pharmacokinetic profiles. Dynogen has exclusive rights under issued U.S. and European patents related to the use of DDP733 as a treatment for GERD.

About Nocturnal Gastroesophageal Reflux Disease (NGERD)

Gastroesophageal reflux disease (GERD) is a chronic condition that afflicts approximately 20 percent of adults in the United States. Persistent heartburn is the most common symptom of GERD, but patients may also experience acid regurgitation into the esophagus, dyspepsia (stomach pain) and dysphagia (difficulty swallowing). GERD affects all age groups, although the incidence increases markedly after the age of 40. If left untreated, complications of GERD can include esophageal erosions or ulcers and abnormal narrowing of the esophagus. Years of chronic heartburn, left untreated, can lead to esophageal cancer, currently the fastest growing cancer in the United States. NGERD is the occurrence of GERD at night, typically while lying down to sleep. Symptoms associated with stomach reflux are exacerbated by the lack of assistance from gravity while lying recumbent. NGERD is commonly associated with a higher risk and a higher degree of esophagitis; acid remains in the esophagus for prolonged periods because there is less swallowing and less saliva produced to neutralize the acid. It is estimated that approximately one-third of patients suffering from NGERD experience symptoms that are uncontrolled by current therapies.

About Dynogen Pharmaceuticals, Inc.

Dynogen is a clinical-stage company developing a portfolio of treatments for gastrointestinal and genitourinary disorders. The Company is focused on large and untapped markets in disease areas that severely impair a patient's quality of life, such as irritable bowel syndrome, gastroesophageal reflux disease and overactive bladder. The Company leverages its development expertise to identify promising clinical compounds and rapidly advance them towards registration. Dynogen currently has multiple double-blind, placebo-controlled Phase 2 studies underway. www.dynogen.com

Contact

Dynogen Pharmaceuticals, Inc.
Mark Boshar, 781-839-5114
mboshar@dynogen.com
or
Media:
MacDougall Biomedical Communications
Kari Watson, 508-647-0209, ext. 11
kwatson@macbiocom.com


'"/>




Related medicine technology :

1. Dynogens DDP733 Reduces Reflux in Phase 1b GERD Study
2. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
3. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
4. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
5. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
6. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
7. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
8. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
9. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
10. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
11. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... Feb. 4, 2016 Global Immunology Market ... to drive long-term market growth Summary ... of chronic disorders that affect 5–7% of western ... of their symptoms and key patient demographics, they ... immune pathways and an inappropriate immune response. Generally, ...
(Date:2/4/2016)... -- Mettler-Toledo International Inc. (NYSE: MTD ) today ... the highlights: , Sales in local currency ... year.  Reported sales decreased 3% as currency reduced sales ... earnings per diluted share as reported (EPS) were $4.44, ... EPS was $4.65, an increase of 10% over the ...
(Date:2/4/2016)... 4, 2016  AMRI (NASDAQ:  AMRI) today announced that ... and President of Pfizer Global Supply, has been elected to ... 2016. In addition, the Company announced that Mr. Gabe ... since 2010, has retired from the AMRI Board of Directors ... other business ventures.  William S. Marth , ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... , ... The event is being held on April 7, 2016 from 5:30 ... Over Parkinson’s will fund nearly $100,000 for research for the care and cure of ... and is the architect of this informative event to raise awareness and funds for ...
(Date:2/5/2016)... ... ... After years as an active staff surgeon and having served as the ... Carman transitioned to chief of the Division of Plastic Surgery at what is now ... and began a second three-year term in January of 2016. , The original selection ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know the routine: each ... longer to access the treadmills. It’s a predictable trend. After the excesses of November ... get in shape by joining gyms, starting new walking or running routines, or signing ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Dr. Justin Scott ... their 2nd Annual No Cost Dental Day to individuals in need. The event is ... of this No Cost Dental Day is to provide dental care to community members ...
(Date:2/5/2016)... ... February 05, 2016 , ... Health and wellness is a ... individuals in the event they are experiencing an illness. Migraines are a severe form ... are afflicted with migraines would not wish the pain on their worst enemy, the ...
Breaking Medicine News(10 mins):