The company is mainly focused on the development and acquisition of late clinical-stage proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions.
Patient enrolment in the double-blind placebo-controlled Phase III trial is expected to start during the third quarter of 2014.
About 320 subjects are expected to be enrolled in the trial, which is planned to be carried out in eight clinical sites in the US.
Based on prior discussions with the FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the trial is intended to support potential future submissions of marketing applications for a new undisclosed indication in both the US and Europe.
The company estimates that, if the trial is successful and the marketing applications are filed and approved by the FDA and the MHRA, the new indication would significantly expand the potential market for RHB-102.
Separately, the company is pursuing marketing approval of RHB-102 for the indications of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV respectively) in Europe and the US.
The company has recently reported positive results from a comparative bioavailability trial comparing RHB-102 and a European reference drug.
Based on the positive results from the bioavailability study and data from prior successful clinical studies, and subject to various regulatory requirements, the company intends to submit a European Marketing Authorization Application (MAA) for RHB-102 during the third quarter of 2014 for the indications of CINV and RINV prevention.
In addition, the company had held a pre-New Drug Application (pre-NDA) meeting in March 2014 with the FDA regarding the development of RHB-102 for CINV and RINV prevention in the US.
After the pre-NDA meeting, and based on the FDA’s feedback, the company provided the FDA with additional information and is currently awaiting the FDA’s response.