Benzinga | May 25, 2021 08:32AM EDT

Acer Therapeutics Announces Outcome Of Pre-NDA Meeting With FDA; Plans NDA Submission For ACER-001 In Q3 2021

Acer Therapeutics Inc. (NASDAQ:ACER)("Acer"), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, and RELIEF THERAPEUTICS Holding AG ((SIX: RLF, OTCQB:RLFTF)("Relief"), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, today announced the outcome of Acer's pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for ACER-001 for the treatment of Urea Cycle Disorders (UCDs). ACER-001 is a proprietary immediate release multi-particulate powder formulation of sodium phenylbutyrate (NaPB) with a taste-masked coating. ACER-001 is being developed in collaboration with Relief.



The purpose of the pre-NDA meeting was to discuss the content of Acer's planned NDA submission. Based on FDA feedback, the Companies believe the proposed data package will be sufficient to support an NDA submission under the Section 505(b)(2) regulatory pathway of ACER-001 for the treatment of patients with UCDs. Following NDA submission and FDA determination of acceptance for filing, the FDA will conduct a substantive review before deciding upon the action on the application.

"We are pleased with the outcome of our recent pre-NDA meeting with FDA, supporting our belief that the studies and data we intend to include in our planned NDA for ACER-001 should be sufficient for NDA submission," said Chris Schelling, CEO and Founder of Acer. "We remain on track to complete the NDA submission in Q3 2021, provided that we obtain agreement with the FDA on our initial pediatric study plan (iPSP)."

Jack Weinstein, CFO and Treasurer of Relief Therapeutics, added: "The outcome of the pre-NDA meeting with the FDA is highly encouraging and marks an important milestone in support of the development and potential commercialization of ACER-001 worldwide. We are pleased with the progress of the ACER-001 program and look forward to working with the Acer team to potentially bring to market an alternative to existing NaPB-based treatments."

ACER-001 is an investigational product candidate which has not been approved by FDA. There can be no assurance that if submitted, an NDA will be accepted for filing and substantive review or, if filed, that an NDA would be approved.