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Company obtains exclusive rights to NDA-enabling clinical data of the company’s lead product, VASEBRA™ (celiprolol), for the treatment of vascular Ehlers-Danlos Syndrome (vEDS)
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acer Therapeutics Inc., a pharmaceutical company developing therapies for serious rare diseases with significant unmet medical need, today announced the signing of an agreement with the Greater Paris University Hospitals AP-HP (via its Department of Clinical Research and Development*) granting the company exclusive rights to access and use data from a randomized controlled clinical study of celiprolol.1 The company will use this pivotal clinical data to support a New Drug Application (NDA) regulatory filing for its lead product, VASEBRA™ (celiprolol), for the treatment of vascular Ehlers-Danlos Syndrome (vEDS).
“We have studied celiprolol for nearly two decades in vEDS patients and this is the only drug ever to demonstrate a clinical benefit in a randomized, controlled clinical study,” said Pierre Boutouyrie M.D., Ph.D., co-director of the clinical pharmacology service at the Georges-Pompidou European Hospital AP-HP and Principal Investigator for the celiprolol study. “Having established celiprolol as a standard of care in France for vEDS patients, we are excited to partner with Acer to help bring celiprolol to members of the U.S. patient community who are suffering from this devastating, life-threatening disease.”
“We are committed to bringing VASEBRA™ to vEDS patients who currently do not have access to this treatment,” said Robert D. Steiner, M.D., Chief Medical Officer of Acer. “This pivotal clinical data from AP-HP will represent a critical element of the clinical module in our NDA, which we are diligently building along with manufacturing, non-clinical and other components of the regulatory package.”
“This collaboration between AP-HP and Acer is a fantastic example of academic-industry partnership,” said Chris Schelling, CEO and Founder of Acer. “The signing of this agreement marks an important corporate milestone as it will enable us to continue to rapidly advance our lead candidate VASEBRA™, a potential life-saving therapy for patients with vEDS, towards an NDA filing.”
Categorized in: Medical & Scientific News