Glenmark Pharmaceuticals has successfully completed phase III trials for HIV-related diarrhoea. It has exclusive marketing and distribution rights to this novel anti-diarrhoeal compound for multiple diarrhoea indications across 140 countries. The completion of top-line analysis of the primary efficacy endpoint from the phase 3 ADVENT trial was announced in the US by Glenmark's partners Napo Pharmaceutical and Salix Pharmaceuticals.
Crofelemer at a daily dose of 125 mg twice daily demonstrated a highly statistically significant improvement in the primary responder analysis, defined as patients having two or less watery stools in two of the four week placebo-controlled phase. Crofelemer was well tolerated in this study, and its adverse event profile was not different from that of the placebo-treated group.
Glenn Saldanha, CEO and managing director of Glenmark, said, “The results from these pivotal phase III studies for Crofelemer in the treatment of HIV-associated diarrhoea are very encouraging for Glenmark as this will accelerate our goal to provide patients access to this drug across multiple diarrhoeal conditions. We are encouraged by these results as we could now prepare for the launch of Crofelemer and this will be our first novel product.”
“Besides HIV-related diarrhoea, most of the markets where Glenmark has exclusive rights have significant incidence of acute diarrhoea especially in young children. Crofelemer has previously shown benefit in patients with mild to severe acute watery diarrhoea. Glenmark will invest significant resources to fast track its development plan to ensure early regulatory approvals and launch in most of our markets.” Saldanha added.
The ADVENT trial is being conducted under a 'fast track' status and has been a part of a 'special protocol assessment' agreement. Due to the adaptive nature of the trial design, the pre-specified p-value for the treatment difference was 0.025. Prevalence of HIV is very high in Glenmark territories with India alone estimated to have 2.5 million people and South Africa with about 9 million people living with HIV. The company anticipates approval of Crofelemer in India in 2012.