A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.
New and updated clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Abbvie, Acelyrin, Arcutis, Concert, Connect, Galderma, Incyte, Inmagene, Leo, Nimbus, Regeneron, Sanofi, Sun, Takeda, UCB.
Takeda Pharmaceutical Co. Ltd.’s oral allosteric tyrosine kinase 2 inhibitor TAK-279 (formerly NDI-034858) met primary and secondary endpoints in a phase IIb clinical trial in patients with moderate to severe plaque psoriasis, but analysts say it may be too little too late to make a big splash compared to competitors.
Protagonist Therapeutics Inc. got a win in its phase IIb study and is making plans for a phase III. JNJ-2113 (formerly PN-235), an oral, interleukin-23 receptor antagonist peptide, hit its primary efficacy endpoint in treating moderate to severe plaque psoriasis. A statistically significant greater proportion of the participants receiving JNJ-2113 saw a 75% improvement in their skin lesions compared to placebo at week 16.
Once-monthly subcutaneous injections of CSL Ltd.’s CSL-312 (garadacimab) significantly reduced the rate of hereditary angioedema (HAE) attacks compared to placebo, meeting both primary and secondary endpoints in the pivotal phase III Vanguard trial. Based on the trial results, CSL will file global regulatory submissions later in 2023.
Biocryst Pharmaceuticals Inc.’s unveiling of real-world data Feb. 24 with its approved Orladeyo (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) brought more attention to the space, due to yield findings from would-be competitors in the near term.
Evelo Biosciences Inc.’s late-stage efforts with EDP-1815 are forging ahead despite unfavorable data in atopic dermatitis (AD), and talks so far with the U.S. FDA have proven encouraging, the company said. Cambridge, Mass.-based Evelo made public findings from the first three cohorts of the phase II trial with EDP-1815 in AD, where the compound fell short of the primary endpoint: proportion of patients who achieve an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index (EASI) score compared to placebo at week 16. Evelo blamed an unusually high placebo response rate.
After working through a complete response letter (CRL) brought about by COVID-19 from the U.S. FDA in June 2021, Mediwound Ltd. has received the agency’s approval for Nexobrid (anacaulase-bcdb) to treat severe burns in adults.
Pediatrix Therapeutics Inc. licensed exclusive China rights to Aclaris Therapeutics Inc.'s ATI-1777 for investigational “soft” JAK 1/3 inhibitor, for diseases including atopic dermatitis, in exchange for an up-front payment of $5 million and up to $91 million in milestones.
Unlike amphibians, mammals do not regenerate appendages. Except when they do. “If you amputate one of the branches off of the antler [of a reindeer], it will also regenerate,” Jeff Biernaskie told BioWorld. Even without amputation, the antlers of both male and female reindeer regenerate annually, including their skin. That regeneration is “the only large mammal model of true skin regeneration,” he said.
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