FDA hits the brakes on Histogen's knee cartilage therapy, asking for more info on manufacturing process

21 Jan 2021
endpts.com
A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock. The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review. Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12. Histogen “plans to work diligently with the FDA to seek the release of the clinical hold and provide updated guidance on any potential impact to the HST-003 program once the written notice from the FDA is received,” the company said in a statement. News of the clinical hold battered Histogen’s $HSTO stock shares in postmarket trading Tuesday, falling 17.8% — a trend which continued after the opening bell Wednesday. Prices fell another 9.3% today and are currently hovering just above $1 per share. The clinical hold for Histogen, which launched in 2005, comes just three months after the regenerative medicine company named Moya Daniels as its EVP and head of regulatory, quality and clinical operations. Daniels makes the move after being SVP of GMP quality at SanBio, and formerly held positions in regulatory affairs and quality assurance at Orchard Therapeutics, Fate Therapeutics and Osiris Therapeutics. Daniels’ addition wasn’t the only operational change at Histogen over the last year, as Susan Knudson came aboard in May as the company’s EVP and CFO. Knudson had held the same titles at Pfenex since February 2018, and had previously been the CFO of Neothetics and the senior director of finance and administration at Avera Pharmaceuticals.
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