January 14, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
Regado Biosciences, Inc. , a development stage biotechnology company, announced today that it has entered a merger agreement with Tobira Therapeutics worth $60 million. Tobira, a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapies for liver disease.
A Tobira investor syndicate has agreed to invest up to $22 million in the joint venture. The financing will fund the company’s lead product, immunomodulator and anti-fibrotic agent cenicriviroc, through its Phase IIb program. All of Tobira’s stock investors have agreed to participate in the financing as well.
“Following an extensive and thorough review of strategic alternatives, we believe the proposed merger with Tobira provides the opportunity for substantial returns for Regado shareholders,” said Michael Metzger, Regado‘s president and chief executive officer. “We expect Tobira to be the next breakout company in NASH based on the best-in-class profile and potential of their lead drug CVC.”
Regado shareholders will own 32 percent of the combined company, and current Tobira shareholders will own about 68 percent. The merger is predicted to close in the second quarter of 2015, assuming the stockholders approve of the deal. Laurent Fischer, the current chairman and chief executive officer of Tobira, will act as the chief executive officer of the merged company. The corporate office will be located in San Francisco, Calif.
“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,” said Fischer.”
The First Dose
In October 2014, Tobira announced that it had given its first dose of CVC to a patient in the CENTAUR study, which examines individuals living with non-alcoholic steatohepatitis and liver fibrosis. As of October, researchers had administered the drug to 580 patients in other Phase I and Phase IIb clinical studies.
“Initiating a Phase IIb clinical study with CVC in NASH, a potentially life threatening liver disease for which there are no approved therapies, is an important milestone for Tobira,” Fischer. “CVC has previously demonstrated dual inhibition of CCR2 and CCR5, key regulators of signaling pathways in NASH that lead to liver damage and disease. This study will help further determine if these drivers are responsive to CVC and advance our clinical investigation of a potential treatment option for patients with NASH.”
CENTAUR is a randomized, double-blind Phase IIb study that examines the use of a 150mg tablet of CVC given once per day to patients versus a placebo.
