CymaBay Therapeutics Inc. (NASDAQ: CBAY) said that it had cut short the Phase 2 proof-of-concept study of MBX-8025. The compound is designed for treatment of Primary Biliary Cholangitis (PBC). The reason for early termination of the trial was that CymaBay felt the study had met its primary objective.
What happened during the study?
According to CymaBay Therapeutics Inc. (NASDAQ: CBAY), MBX-8025 showed improvement in patients afflicted by PBC. In particular, the compound showed improvements in cholestasis biochemical markers, which was the target of the proof-of-concept study.
What’s next for CymaBay Therapeutics Inc. (NASDAQ: CBAY)?
The positive results of the Phase 2 study of MBX-8025 now pave the way for CymaBay to continue the development of the drug, but with more confidence about what to expect in future trials.
In the future studies, CymaBay Therapeutics Inc. (NASDAQ: CBAY) will be seeking to assess lower doses of MBX-8025 with the aim of optimizing risk benefit. During the proof-of-concept study, MBX-8025 was administered in the doses of 200mg and 50gm.
A solution in sight for sufferers of PBC?
The proof-of-concept study as clearly pointed the direction that CymaBay needs to take with MBX-8025. When you listen to CymaBay’s CEO, Harold Van Wart, you get a sense that he believes they have edged closer to bringing a relief to patients afflicted by PBC.
Other health experts such as Keith Lindor of Arizona State University believe that exploring lower doses of MBX-8025 provides CymaBay with the best shot to bring the treatment to market.
How was the study conducted?
CymaBay said the proof-of-concept study was double-blind, placebo controlled. The study ran for 12 weeks.
Does CymaBay have what it takes to develop MBX-8025?
CymaBay Therapeutics Inc. (NASDAQ: CBAY) finished 1Q2016 with cash and equivalents of $35.3 million. The management said the available funds should be adequate to finance the company’s activities until at least 2Q2017. Perhaps by that time the company could have secured additional capital to keep it in business longer. CymaBay funneled $4.4 million to R&D activities during 1Q2016, a slightly higher than $4.2 million in the like quarter a year ago.