Israeli-based biopharmaceutical company, RedHill Biopharma Ltd., has received Investigational New Drug Application (IND) approval from the US FDA, for an advanced clinical trial with RHB-102 for the prevention of nausea and vomiting in cancer patients. The IND approval follows the recent Clinical Trial Application (CTA) approval from Health Canada.

Based on advice from the company’s regulatory advisors and preliminary discussions held with US FDA regarding the requisite regulatory route, if positive results are obtained and certain FDA requirements are met, the clinical trial may be considered a pivotal one (phase III-equivalent), to be used by the company for submitting a US marketing approval application (NDA - New Drug Application).

The IND means that the FDA has no objection to the commencement of the clinical trial on the basis of the submitted trial protocol.

The planned RHB-102 clinical trial is a bioequivalence study which aims to test the pharmacokinetic similarity between RedHill's once-daily controlled release tablet formulation and Zofran, GlaxoSmithKline's well known, leading, approved antiemetic drug administered several times per day.

The RHB-102 clinical trial is expected to commence in Canada during the first quarter of 2012 and is expected to last several months up to final analysis of its results.

RHB-102 is a patent protected once-daily controlled release tablet formulation of the active ingredient Ondansetron, a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic (i.e. for prevention of nausea and vomiting). The drug market for serotonin receptor inhibitors (the drug family of RHB-102) is estimated at approximately $1 billion.

Gilead Raday, VP Corporate & Product Development at RedHill Biopharma stated:  "The IND from the FDA is an important step in the regulatory development of RHB-102. The clinical results previously demonstrated by RHB-102 were encouraging. Should RHB-102 be approved for marketing in the future, it may become an important therapy in support of cancer patients suffering from nausea and vomiting".  

RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development of late clinical-stage new formulations of existing drugs.