Napo, Glenmark to start phase 2 acute infectious diarrhea trial in India

By Elaine Rigoli

Tampa, Fla., Aug. 3 - Napo Pharmaceuticals, Inc. has received approval from the Drug Controller General of India to start a phase 2 trial with crofelemer, Napo's proprietary gastrointestinal compound for the treatment of acute infectious diarrhea.

Glenmark Pharmaceuticals Ltd., Napo's product development and commercialization partner for crofelemer in India and more than 110 emerging and developing countries, will start the trial.

Upon marketing, Glenmark will pay up to 14% royalties to Napo.

The trial is expected to start later this year and will involve 60 adult patients suffering from acute diarrhea in a prospective, randomized, parallel group using a controlled, double-blind placebo method.

The trial will be concluded within three months from the start of dosing, according to a news release.

Glenmark is also working on a development plan for the other indications of AIDS-related diarrhea and pediatric diarrhea.

"We are advancing our pipeline according to schedule and look forward to furthering the development of this important compound," chief executive officer Lisa Conte said in the release.

Napo is a biopharmaceutical company based in South San Francisco, Calif.

Glenmark is a biopharmaceutical company based in Mumbai, India.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.