A phase IIb clinical study has Frequency Therapeutics Inc. reeling and making big changes, including layoffs. The placebo-controlled phase IIb study of FX-322 in treating acquired sensorineural hearing loss by regenerating hair cells in the cochlea missed its primary efficacy endpoint, so the company is discontinuing the program. It’s also shutting down a phase Ib study of FX-345, a program for treating the same indication.
Disappointing phase II antitumor results with a drug that is designed to preserve the bone marrow during chemotherapy have dashed G1 Therapeutics Inc.’s hopes of expanding Cosela’s label to include metastatic colorectal cancer patients, at least for now. Cosela (trilaciclib) is an intravenous-administered transient CDK4/6 inhibitor designed to mitigate the side effects patients experience with current cytotoxic drug regimens used to treat aggressive cancers by offering myeloprotection and by preserving immune system function, so enabling patients to receive chemotherapy for longer and at higher doses.
Biomedical Research & Bio-Products (Bio&Bio) AG is laying plans for a phase III trial of its vaccine for preventing methicillin-resistant Staphylococcus aureus infections from sparking toxic shock syndrome, after delivering phase II data showing good safety and immunogenicity.
Leveraging ferroptosis, or iron-mediated cell death, Hillstream Biopharma Inc. has turned up intriguing early stage data in non-small-cell lung cancer (NSCLC) when the company’s candidate called HSB-1216 was paired with the anti-PD-1 antibody Keytruda (pembrolizumab, Merck & Co. Inc.).
Privately held Vivacelle Bio Inc. has completed its phase IIa study of VBI-S in treating septic shock patients with severe hypovolemia, a drastic drop in blood pressure that can lead to organ failure and death. In the study, VBI-S, an intravenously injected fluid composed of phospholipid nanoparticles, increased blood pressure and improved organ function.
Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s experimental COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) 23% on Feb. 9 as the company continues to seek regulatory approval. That approval path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA.
Roche Holding AG’s investigational monoclonal antibody, crovalimab, which inhibits part of the innate immune system in patients with the rare blood condition paroxysmal nocturnal haemoglobinuria, met its co-primary efficacy endpoints in a phase III trial that will form the basis of its approval submissions worldwide.
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
Shares in Idorsia Ltd. plummeted by around 14% Feb. 6 as the company announced that its phase III REACT trial investigating the use of Pivlaz (clazosentan) failed to reach the primary endpoint in patients who had experienced a type of stroke called aneurysmal subarachnoid haemorrhage, leaving the drug’s future in the U.S. and Europe uncertain.
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