Regado Biosciences, a development stage biotechnology company based in Basking Ridge, N.J., and Tobira Therapeutics, a clinical-stage biopharmaceutical company in South San Francisco, have agreed to merge. Privately held Tobira will merge with a wholly-owned subsidiary of Regado in an all-stock transaction. The merger will create a company focused on the development of novel treatments for liver and inflammatory diseases.
Tobira's lead product, immunomodulator and anti-fibrotic agent cenicriviroc (CVC), received Fast Track designation and currently is in a phase IIb trial in non-alcoholic steatohepatitis (NASH). Regado will be renamed Tobira Therapeutics and will be under the leadership of Tobira's CEO, Laurent Fischer, M.D.
A Tobira investor syndicate has committed to invest up to $22 million in the combined company. This financing is expected to fully fund the CVC development program through the completion of the phase IIb program. Total cash balance of the combined company following the closing of the merger and the financing is expected to be approximately $60 million.
Fischer said, "The merger and concurrent financing will allow the company to fully fund Tobira's ongoing phase IIb Centaur study of CVC in patients with NASH and liver fibrosis. We expect to have top line data from the study in the second quarter of 2016. In addition, the strong closing balance sheet allows us to expand our NASH program with additional studies of CVC in non-alcoholic fatty liver disease and combination settings that will help position CVC as a cornerstone therapy for this troubling complication of the ongoing obesity epidemic."
CVC is a first-in-class immunomodulator and the only compound in development for NASH that targets inflammation and fibrosis. It has been evaluated in approximately 580 subjects across clinical programs. CVC is being evaluated in patients with NASH for its potential to reduce liver inflammation and slow down or reverse progression of liver fibrosis or progression to cirrhosis.
The Centaur study is a randomized, double-blind phase IIb study of a single 150mg tablet of CVC given once daily versus placebo in patients with NASH and liver fibrosis. Centaur is an international study with planned treatment centers across North America, Europe, Hong Kong and Australia. The study will enroll approximately 250 patients and will evaluate the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) and resolution of NASH without worsening of liver fibrosis after one and two years of treatment as compared to placebo.
These endpoints are aligned with findings and recommendations from an American Association for the Study of Liver Diseases (AASLD)/FDA joint workshop that identified potentially acceptable surrogate endpoints for clinical studies of agents for NASH and liver fibrosis, a disease for which no treatments are approved.
The merger is expected to close in the second quarter of 2015, subject to the approval of the stockholders of each company as well as other customary conditions.
Following the merger, the company will be led by Fischer as CEO. The board of directors of the combined company will be comprised of nine representatives, three of whom will be designated by Regado and the remaining six to be designated by Tobira. Dennis Podlesak, current chairman of Regado's board, will chair the board of the combined company. Corporate headquarters will be located in South San Francisco.