Dynogen's DDP733 Reduces Reflux in Phase 1b GERD Study ( stablishing appropriate doses forour l...)

Dynogen's DDP733 Reduces Reflux in Phase 1b GERD Study

stablishing 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-HT3). 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.

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