Acer Therapeutics Inc (NASDAQ: ACER) stock surged by 28.7% after its EDSIVO™ (celiprolol) drug treatment was granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA).
Celiprolol is a drug targeted at treating patients with COL3A1-positive vascular Ehlers-Danlos syndrome (vEDS). The designation was awarded given that there are no approved treatments for vEDS globally.
Adrian Quartel, MD, Acer’s Chief Medical Officer, said: “With no currently approved treatments for vEDS anywhere in the world, this designation by FDA marks an important step forward in support of our goal to provide treatment options like EDSIVO™ to rare disease patients, who are often overlooked or underserved,”
“We look forward to continuing our discussions with FDA, through the SPA process, to seek agreement on the protocol design of the proposed pivotal Phase 3 DiSCOVER trial that we plan to initiate by the end of Q2 2022 once an agreement is reached.”
The designation will allow Acer Therapeutics to expedite celiprolol’s development through the remaining clinical trial process and commercialisation.
The drug had received its investigational new drug (IND) application approval from the FDA in January this year. Acer is currently in discussions with the FDA regarding a special protocol assessment (SPA) that will affect the design and size of its clinical trial.
Acer Therapeutics told investors that its phase III trial would enrol up to 150 patients based on initial statistical power calculations. The trial took up to 3.5 years to complete once all the patients had been enrolled.
Given the multi-year timeframe, investors should brace themselves for multiple updates regarding the clinical trial, and there is still a significant chance that the trial may not be successful.
Acer shares had given up most of their initial gains at writing and were trading up 5.48%.
*This is not investment advice. Always do your due diligence before making investment decisions.
Acer Therapeutics stock price.
Acer Therapeutics stock price surged 28.76% to trade at $3.76, rising from Friday’s closing price of $2.92.
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