CymaBay Therapeutics Announces an Oral Late-Breaking Presentation of Results from the ENHANCE Global Phase 3 Study Evaluating Seladelpar for Primary Biliary Cholangitis at The Liver Meeting® 2020

Rhea-AI Summary

CymaBay Therapeutics (CBAY) announced a late-breaking presentation of the ENHANCE Phase 3 study results for seladelpar, focused on primary biliary cholangitis (PBC), to be held at The Liver Meeting Digital Experience™ 2020 from November 13-16. The oral presentation, led by Professor Gideon Hirschfield, aims to share efficacy and safety data regarding seladelpar, an innovative therapy receiving orphan designation from the FDA and EMA for PBC. CymaBay is also preparing to initiate a new global Phase 3 study to support seladelpar's registration.

Positive

• Presentation of ENHANCE Phase 3 study results at a prominent liver disease conference.
• Seladelpar received orphan designation from FDA and EMA, enhancing its market potential.
• Planning a new global Phase 3 study to support registration of seladelpar for PBC.

Negative

• None.

NEWARK, Calif., Nov. 02, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that a late-breaking presentation highlighting results from the ENHANCE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be delivered during The Liver Meeting Digital Experience™ 2020 (TLMdX) of the American Association for the Study of Liver Diseases (AASLD) which will be held online November 13^th – 16^th.

The oral presentation titled “ENHANCE: Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis (PBC) – A Phase 3 International, Randomized, Placebo-Controlled Study,” ¹ will be delivered by Professor Gideon Hirschfield, MD, University of Toronto.

Sujal Shah, CEO of CymaBay Therapeutics, commented, “We are honored to be presenting data once again from our development of seladelpar for patients with PBC at this year’s AASLD Liver Meeting. We look forward to sharing additional results from the ENHANCE study as we focus on initiating a new global Phase 3 study to support the registration of seladelpar for PBC. We believe the opportunity to present in the late-breaking session at The Liver Meeting® for a fourth consecutive year is a remarkable achievement and a reflection of the potential for seladelpar to address significant unmet needs that remain for patients with PBC. We remain committed to these patients and their families and are grateful for their participation in our studies.”

Oral Presentation Late-Breaking Presentation

November 16^th 2:00 PM EST

LO11:
¹“ENHANCE: Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis (PBC) – A Phase 3 International, Randomized, Placebo-Controlled Study”
Gideon Hirschfield, Kris Kowdley, Mitchell Shiffman, Arun Khazanchi, Ehud Zigmond, Eric Lawitz, Dan Pratt, Richard Aspinall, Lisa Forman, Stuart Gordon, Aliya Gulamhusein, Alma Laura Ladron-De-Guevara, Cynthia Levy, Stephen Ryder, Carmen Stanca, Carlos Bresky Ruiz, Maria Sarai Gonzalez Huezo, Jeong Heo, Barbara Leggett, Gerald Minuk, Mangesh Pagadala, David Pound, Karina Raikhelson, Marina Silveira, Mark Swain, Kidist Yimam, Ziad Younes, Eli Zuckerman, Christophe Corpechot, Stephen Harrison, Pietro Invernizzi, Frederik Nevens, Douglas Thorburn, Christopher Bowlus, George Dalekos, David Jones, Andreas Kremer, Albert Pares, John Vierling, Pol Boudes, Monika Varga, Yun Choi, Charles McWherter, Alexandra Steinberg, Marlyn Mayo

Congress attendees can visit CymaBay throughout the meeting at the CymaBay booth in the Exhibitors section of the TLMdX homepage.

A full list of presentations can be found on The Liver Meeting Digital Experience™ 2020 website.

The presentations will also be made available on the CymaBay website.

About PBC
PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40. PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP) and total bilirubin. The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients. Progression of PBC is associated with an increased risk of liver cancer and liver-related mortality.

About Seladelpar
Seladelpar is a potent, selective, orally active PPARδ agonist that has been in development for the treatment of the liver diseases primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicine status from the EMA.

About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need.

Cautionary Statements
The statements in this press release regarding the potential for seladelpar to treat NASH or PBC, the potential benefits to patients, CymaBay’s expectations and plans regarding its current and future clinical trials and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide or to potentially restart clinical trials. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

For additional information about CymaBay visit www.cymabay.com.

Public Relations Contact:

Glenn Silver
Lazar-FINN Partners
(973) 818-8198
Glenn.silver@finnpartners.com

Investor Relations Contact:

Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com

FAQ

What are the results of the ENHANCE Phase 3 study for seladelpar?

Results will be presented at The Liver Meeting Digital Experience™ 2020, emphasizing the safety and efficacy of seladelpar in treating PBC.

When will the oral presentation on seladelpar take place?

The presentation is scheduled for November 16, 2020, at 2:00 PM EST.

What is seladelpar used for?

Seladelpar is developed for the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).

What designations has seladelpar received?

Seladelpar has received orphan designation from both the FDA and EMA, as well as Breakthrough Therapy Designation from the FDA.

What is the significance of the upcoming Phase 3 study for seladelpar?

The new Phase 3 study aims to support the registration of seladelpar for PBC, potentially enhancing treatment options for patients.