In addition to the layoffs, Acer said it has halted pre-commercial activities surrounding Edsivo due to the FDA’s rejection last month.
Two weeks after the U.S. Food and Drug Administration rejected Acer Therapeutics’ New Drug Application (NDA) for Edsivo (celiprolol), the company initiated a restructuring plan that includes the elimination of 29 employees in order to extend its cash runway through the end of 2020.
Over the holiday weekend, Acer announced the restructuring plan. Acer did not provide financial specifics regarding the layoffs, nor did the company specify when those layoffs will occur. Shares of Acer fell nearly 8% following the announcement.
The Newton, Mass.-based company said it plans to discuss the FDA’s requirements for a new clinical trial for potential approval of Edsivo, a treatment in development for vascular Ehlers-Danlos syndrome (vEDS), the most severe subtype of a group of hereditary diseases of the connective tissue. While it seeks a path forward for the New Drug Application, Acer said it intends to halt pre-commercial activities for Edsivo. In Late June, the regulatory agency issued a Complete Response Letter to Acer for Edsivo. Before it could consider approval for the drug, the FDA said Acer will need to run an “adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.”
Acer Chief Executive Officer Chris Schelling, said the CRL made it necessary to reduce company expenses in order to focus on the potential approval of Edsivo and the other assets in the company pipeline.
“While we are disappointed by the CRL, we intend to continue our dialogue with the FDA to fully understand its response and work toward our goal of approval of Edsivo for confirmed COL3A1+ vEDS patients, who currently have no approved treatment options,” said Schelling, who is also the founder of Acer.
While Acer was light on the details regarding its restructuring, the company did note that it will also continue to focus on the development of other pipeline programs, including ACER-001 and osanetant. In the fourth quarter of 2019, Acer said it will initiate a pivotal bridging study of ACER-001, a fully taste-masked, immediate release formulation of sodium phenylbutyrate, in patients with a Urea Cycle Disorder under an active Investigational New Drug application. Sodium phenylbutyrate has been found to help control blood ammonia levels in conjunction with a restricted diet for people with UCD, but Acer said there is a high rate of non-compliance with current treatments due to the cost and a bad taste. Acer believes the taste-masked properties and competitive pricing of ACER-001 could make it a compelling alternative to existing treatments. If successful, the company said it could file a New Drug Application for ACER-001 in the first half of 2020. The Company also intends to develop ACER-001 for patients with Maple Syrup Urine Disease, n autosomal recessive metabolic disorder. It has been granted orphan drug designation by the FDA in this indication.
Acer is also developing osanetant, a clinical-stage, selective, non-peptide tachykinin NK3 receptor antagonist it acquired from Sanofi last year. Acer expects to disclose specific indications for the development of osanetant in late July 2019 and to initiate a clinical study by mid-2020 to evaluate pharmacokinetics, pharmacodynamics and safety of osanetant in patients with various rare and life-threatening neuroendocrine disorders.
