Promising early data continue to roll out for Intellia Therapeutics Inc.’s hereditary angioedema (HAE) candidate, NTLA-2002, with one of the earliest treated patients in the phase I study remaining attack-free for more than a year. But it was the systemic CRISPR candidate’s potential as a one-time treatment that generated the most discussion on the company’s call as investors tried to assess its potential advantage in a crowded HAE market.
Researchers from Universität zu Köln have published data from a study that investigated the pathophysiology of disabling pansclerotic morphea (DPM), and as such, gain better understanding of the much larger range of disorders characterized by poor wound healing and severe, unchecked fibrosis.
Emris Pharma, a recent spin-off of Hadasit Medical Research Services and Development Ltd. and Yissum Research Development Co., has started development of a new topical drug to treat skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitors used to treat cancer.
At the recent American Transplant Congress, researchers from McGill University presented the discovery and preclinical evaluation of a novel retinoic acid receptor-related orphan receptor γt (RORγt) inhibitor, TF-S14, being developed as a potential therapy to delay skin allograft rejection.
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines.
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
Canbridge Pharmaceuticals Inc. obtained marketing approval from China’s NMPA for CAN-108 (Livmarli; maralixibat chloride oral solution) to treat cholestatic pruritus in 1-year-old or older patients with Alagille syndrome, a development that the company touted for how quickly it followed similar approvals elsewhere.
Additional data from a phase II trial of S1P modulator icanbelimod (CBP-307) reinforced earlier positive results in ulcerative colitis (UC), potentially putting Connect Biopharma Holdings Ltd. in a better negotiating position as it seeks a partner to take the program forward, while in-house activities remain focused on an early 2024 regulatory filing for atopic dermatitis candidate CBP-201.
Liminal Biosciences Inc. has nominated a lead preclinical candidate, LMNL-6326, from its oxoeicosanoid receptor 1 (OXER1) antagonist program, targeting the treatment of eosinophil-driven diseases such as eosinophilic asthma and atopic dermatitis.
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