Risk-sharing agreement with Abingworth will fund seladelpar Phase 3 development program for PBC
CymaBay retains full worldwide commercial rights to seladelpar
“CymaBay continues to seek the most capital efficient way to fund its pipeline with today’s announcement of a strategic funding arrangement with Abingworth to support the completion of the Phase 3 development program for seladelpar in PBC,” said
Under the terms of the transaction, CymaBay will receive up to
CymaBay is currently dosing patients in its Phase 3 RESPONSE clinical trial as well as its ASSURE open- label extension trial and other Phase 1 NDA-enabling clinical studies.
“We are excited to provide CymaBay with the capital needed to advance seladelpar through Phase 3 trials with the aim of bringing this important medicine to patients in real need,” said
Perella Weinberg Partners and
About Seladelpar
Seladelpar is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acids synthesis, inflammation, fibrosis and lipid metabolism, storage and transport.
About RESPONSE
RESPONSE (NCT04620733) is a 52-week, placebo-controlled, randomized, global Phase 3 study to evaluate the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC). Approximately 180 PBC patients will be randomized to seladelpar 10 mg/day, or placebo. Patients must have an inadequate response to UDCA (defined as a serum alkaline phosphatase level ≥ 1.67 x the upper limit of normal after at least 12 months of treatment) or an intolerance to UDCA to be eligible for the study. Patients who are inadequate responders to UDCA will continue their UDCA treatment during the study. The primary outcome measure will be the responder rate at 52 weeks, where a responder is defined as a patient who achieves an alkaline phosphatase level < 1.67 x the upper limit of normal with at least a 15% decrease from baseline and has a normal level of total bilirubin. Additional key outcomes of efficacy will compare the rate of normalization of alkaline phosphatase at 52 weeks and the level of pruritus at 6-months for patients with moderate to severe pruritus at baseline assessed by a numerical rating scale recorded with an electronic diary. To learn more, visit www.pbcstudies.com.
About CymaBay
About Abingworth
Abingworth is a leading transatlantic life sciences investment firm. Abingworth helps transform cutting-edge science into novel medicines by providing capital and expertise to top calibre management teams building world-class companies. Since 1973, Abingworth has invested in 175 life science companies, leading to 44 M&As and 71 IPOs. Our therapeutic focused investments fall into three categories: seed and early-stage, development stage, and clinical co-development. Abingworth supports its portfolio companies with a team of experienced professionals at offices in
Cautionary Statements
Any statements made in this press release regarding the funding expected to be provided by Abingworth and payment schedule, as well as the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, and CymaBay’s expectations and plans regarding its current and future clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the funding and 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 agreement with Abingworth may be terminated by Abingworth under certain circumstances; there is no assurance that CymaBay will be able to meet its requirements under the Abingworth agreement; 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
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