Pharmaceutical company focusing on acquisition and commercialisation of therapies for serious rare and life-threatening diseases, Acer Therapeutics (NASDAQ:ACER),announced on July 29, 2021 that after recent Type B meeting with U.S. FDA on Acer’s proposed EDSIVO development plan, the firm plans a pivotal clinical trial in patients with COL3A1+ vascular Ehlers-Danlos Syndrome.
The firm in 2021 second half aims to submit protocol for prospective study in addition to investigational new drug application, ask breakthrough therapy designation and coordinate for reaching agreement on Special Protocol Assessment.
EDSIVO, an investigational drug, is unapproved by FDA presently and there is no surety on funding for conducting and completing clinical trial.
Chris Schelling, CEO and Founder of Acer, said that the company appreciates the guidance of FDA on design of the proposed clinical trial. Scheling said that in next six months, it will work closely for finalising protocol for the pivotal trial as well as collaborate with vEDS advocacy groups.
Completion of clinical trial will be subjected to Acer’s ability for getting $10 million of funding. The financing may come from a number of sources, including cash, strategic partnership as well as other non-dilutive sources.
The firm opines its cash and cash equivalents is $20.0 million of Development Payments per the ACER-001 Collaboration Agreement with Relief Therapeutics.