Replies to post #136723 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

In my experience these announcements are made as an when the event occurs, like this one just now:

Enrollment Begins in Long-Term Extension Study of Seladelpar in Patients with Primary Biliary Cholangitis

Study allows continued access to long-term treatment with seladelpar in support of the phase 3 registration program
Patients currently enrolling have now completed one year of treatment in the phase 2 low dose study


NEWARK, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that the first primary biliary cholangitis (PBC) patients have been successfully enrolled in the seladelpar long-term extension study (NCT03301506). The study entitled “An Open-Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)” is an international Phase 2/3 study that is being conducted both in North America and Europe.  The study will provide access to long-term seladelpar treatment for patients enrolled in a previous or ongoing study evaluating seladelpar for the treatment of PBC. The objectives of the study are to provide additional long-term safety and efficacy data that will support the seladelpar registration program and to follow patients until registration of seladelpar.

The long-term extension study is currently enrolling patients that complete the Phase 2 low dose seladelpar study (NCT029556022). Positive interim results from this Phase 2 study1 were shared with the scientific community during a late-breaking presentation on October 23, 2017 in Washington, DC at The Liver Meeting® hosted by the American Association for the Study of Liver Diseases.

“We are very excited to continue to provide seladelpar to PBC patients who enrolled in our clinical development program,” said Pol Boudes, M.D., Chief Medical Officer, CymaBay. Dr. Boudes added, “Our patients and their families have made immense contributions toward building our understanding around the potential for seladelpar to treat PBC and along with our investigators, have helped us advance the program to Phase 3. The long-term extension study also fulfills an important commitment of CymaBay to provide PBC patients who benefit from seladelpar continued and uninterrupted access to the drug.”

1. Hirschfield GM, Bowlus CL, Harrison SA, et al. Treatment efficacy and safety of low dose Seladelpar, a selective PPAR- d agonist, in patients with primary biliary cholangitis: twelve-week interim analysis of an international, randomized, dose ranging, phase 2 study. LB-4. Hepatology 2017;66(6S):1256A