Acer is a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Our pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Our product candidates are believed to present comparatively de-risked programs as evidenced by having one or more of the following: favorable safety profile, clinical proof-of-concept data, mechanistic differentiation, and/or accelerated pathways for development through specific programs and procedures established by the United States (U.S.) Food and Drug Administration (FDA).
$ Additional capital resources required to fund these programs going forward
* In response to a Complete Response Letter from the FDA for our New Drug Application (NDA) for EDSIVO™ for the treatment of patients with vEDS with a confirmed COL3A1 mutation, we submitted a Formal Dispute Resolution Request which was denied in March 2020 by the FDA’s Office of New Drugs. However, the Office of New Drug’s denial described possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO™ NDA
These pipeline products are under investigation and their safety and efficacy have not been established. There is no guarantee that any of these products will receive health authority approval or become commercially available for the uses being investigated.