Pharmos to develop, partner or outlicense Vela assets

By Elaine Rigoli

Tampa, Fla., April 5 - Pharmos Corp., which recently said it plans to acquire Vela Pharmaceuticals, Inc., announced new priorities for Vela's later-stage assets, including dextofisopam and tianeptine for the treatment of irritable bowel syndrome (IBS) and VPI-013 for the treatment of neuropathic pain and female hypoactive sexual desire disorder (HSDD).

"Since our announcement, we have been working diligently with Pharmos and believe that we are well on our way to a smooth and successful transition. We are working together with Pharmos as we plan the phase 2b IBS study with dextofisopam," senior vice president of research and development Steve Leventer said in a news release.

"We are jointly considering next steps with tianeptine, our follow-on IBS treatment, which demonstrated activity in the same preclinical tests as dextofisopam. We are also exploring the development of VPI-013 for the treatment of HSDD and for the treatment of neuropathic pain. Pharmos has encouraged Vela to continue to seek potential partners for the development of VPI-013 in both indications," he added.

In January 2005, Vela announced positive results from its phase 2 clinical trial of dextofisopam for the treatment of IBS. Dextofisopam provided statistically significant benefit in patients with either diarrhea-predominant or alternating-type IBS.

In patients with diarrhea-predominant IBS, reduced stool frequency and improved stool consistency were noted as early as the second day of treatment, the release said.

Vela and Pharmos are planning a dose-ranging trial with dextofisopam in women with diarrhea-predominant and alternating-type IBS. The study is anticipated to enroll about 480 patients at up to 80 sites in the United States and is expected to begin later this year or early 2007.

Pharmos also announced that Vela is collaborating with Otsuka Pharmaceutical Co., Ltd. on the development of VPI-013.

Vela licensed U.S. and European rights to VPI-013 from Otsuka, the release said.

In Vela's phase 2 trial of VPI-013 in depressed patients, the drug showed some antidepressant activity but did not achieve statistical significance on the primary depression endpoint.

Compared with a placebo, VPI-013 significantly improved overall sexual function, sexual desire/frequency and sexual desire/interest, the release said.

Although the primary purpose of this study was not to determine the effect of VPI-013 on sexual function, patients had a significant degree of sexual dysfunction coming into the study, and a positive effect of VPI-013 on sexual function was evident, officials said.

The company said the data suggests that VPI-013 improved libido and therefore may have potential for treating sexual dysfunction in men and women.

Vela has also conducted preclinical studies in rodents, with results suggesting that VPI-013 has potential for the treatment of neuropathic pain.

Based in Ewing, N.J., Vela specializes in the development of medicines related to the nervous system, including the brain-gut axis.

Based in Iselin, N.J., Pharmos discovers and develops novel therapeutics to treat a range of indications, including neurological and inflammatory disorders.

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