The steadily percolating psychedelic drug space stands poised to generate a near-term stream of potentially encouraging developments in a range of mental health disorders, including depression, anxiety, post-traumatic stress disorder and more.
After gaining emergency regulatory approval in Japan for its oral COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), Shionogi & Co. Ltd. is advancing several global phase III trials across a wide range of COVID-19 patient populations. Branded as Xocova in Japan, ensitrelvir received emergency regulatory approval from Japan’s Ministry of Health, Labour and Welfare in late November 2022 for SARS-CoV-2 infection based on the results from phase II/III trials in non-hospitalized patients in Asia.
Replay Holdings LLC said it will be first into the clinic with a T-cell receptor natural killer (TCR-NK) cancer immunotherapy, after forming its latest satellite company around technology from the University of Texas MD Anderson Cancer Center. No financial details were disclosed, but the newco, Syena, is funded to run a basket trial that will assess an NY-ESO-1-targeted TCR-NK in a number of hematological and solid tumors, and said it will start treating patients in the second half of 2023.
Updated MRI results from Clene Inc.’s phase II Visionary-MS trial testing gold nanocrystal therapy CNM-Au8 bolsters the company’s premise that targeting energy metabolism could protect neuronal function in patients with multiple sclerosis and lays the groundwork for a phase III trial as soon as a strategic partner is found.
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.
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