Pledging a comeback, Acer axes pre-commercial ops, chops staffers in wake of CRL
Days ago the FDA slammed its door on Acer Therapeutics’ pitch for celiprolol, blocking any path to market that the company saw for the old beta blocker. Execs now say they are nixing all pre-commercial activities in the aftermath, which is also claiming almost two-thirds of its workforce.
But they are not giving up on that lead program. By bringing the headcount down to 19 from 48, Acer hopes to free up resources for the development of celiprolol as well as two other pipeline projects. The cash runway is expected to extend through the end of 2020.
Celiprolol is an off-patent drug approved in Europe for hypertension well over 30 years ago but never submitted for FDA approval.
Acer acquired it with the goal of selling it in the US as a treatment for vascular Ehlers-Danlos syndrome — a rare, inherited connective tissue disorder that can cause problems in the arteries, muscles and internal organs — in a move that critics compare to the controversial case at Marathon Pharmaceuticals.
A group of French scientists had conducted a small 54-patient trial that showed the drug could reduce arterial ruptures and dissections — with the caveat that the study was underpowered.
“Acer bought the data rights and obtained orphan designation, but has not conducted further trials as far as we can tell,” Frank David of the biotech consultancy Pharmagellan said last January after publishing a pre-print paper decrying the tactic.
The FDA has asked for another clinical trial in its complete response letter, though the company didn’t specify the data regulators are looking for.
“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 Chris Schelling, CEO and founder of Acer, in a statement.
Needham analyst Serge Belanger had estimated a target market opportunity between $200 million and $400 million based on expected pricing of $100,000 to $200,000 per patient.
Other clinical projects at Acer include ACER-001, a formulation of sodium phenylbutyrate that gets rid of the unpleasant taste Acer believes is core to non-compliance among patients with urea cycle disorders; and Sanofi castoff osanetant for a number of neuroendocrine disorders to be disclosed later this month.
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