Apogee Therapeutics Inc.’s phase I home run put IL-13-targeting antibody APG-777 on an accelerated development path in atopic dermatitis, and the company touted its similarity to further-along IL-13 competitor lebrikizumab, from Eli Lilly and Co., as a likely indicator of further success.
On the verge of top-line data from its phase IIb trial with oral small-molecule CC chemokine receptor 4 (CCR4) antagonist zelnecirnon in atopic dermatitis (AD), due around the middle of this year, Rapt Therapeutics Inc. said the U.S. FDA has imposed a clinical hold on that study with the otherwise promising drug, also known as RPT-193, in AD as well as the phase IIa trial with the same compound in asthma.
Kalvista Pharmaceuticals Inc.’s positive phase III news Feb. 13 with sebetralstat, an oral on-demand kallikrein inhibitor, in hereditary angioedema (HAE), sparked Wall Street speculation about competitor Pharvaris BV with deucrictibant, a bradykinin B2 receptor antagonist.
Kalvista Pharmaceuticals Inc. is promising to “change the paradigm” in the treatment of hereditary angioedema, after announcing positive phase III data for its oral on-demand kallikrein inhibitor sebetralstat. Rather than waiting four to five hours to self-administer therapy, as is the case for approved injectable on-demand therapies, there was a median time to dosing of 10 minutes after the start of an attack in the ongoing open label extension trial and a median time to dosing of 41 minutes in the 136-patient placebo-controlled phase 3 trial.
Medicxi is spinning six of its early stage companies into an immuno-dermatology specialist and turbocharging development with a $100 million seed round.
Allakos Inc. terminated all development of its lead drug, anti-Siglec-8 antibody lirentelimab (AK-002), and is cutting its workforce in half, following phase II failures for atopic dermatitis and chronic spontaneous urticaria. The San Carlos, Calif.-based company will now focus on phase I trials for anti-Siglec-6 antibody AK-006 as part of a restructuring that stretches the runway into mid-2026. Shares (NASDAQ:ALLK) sank by 60.2%, down $1.80, to close at $1.19 on Jan. 16.
Argenx SE CEO Tim Van Hauwermeiren said that, with subcutaneous efgartigimod (efgartigimod alfa and hyaluronidase-qvfc) in pemphigus, the company is “facing a situation where, even with a strong scientific hypothesis and well-executed trial, we encountered the unknown-unknown,” and the phase III experiment failed. “We are committed to doubling down” on the execution of the firm’s business plan, he added.
The data package for Filsuvez (birch triterpenes), a topical gel aimed at treating partial thickness wounds, satisfied U.S. reviewers the second time around. Chiesi Group said the FDA approved the treatment Dec. 19 for use in patients 6 months and older with rare blistering skin diseases junctional epidermolysis bullosa and dystrophic epidermolysis bullosa.
Pharvaris NV’s phase II top-line data from the Chapter-1 trial testing oral bradykinin B2 receptor antagonist deucrictibant in hereditary angioedema (HAE) wowed Wall Street and sparked speculation regarding where the drug might fit in the increasingly competitive landscape.
Connect Biopharma Holdings Ltd. has been seeking a partner for its atopic dermatitis candidate rademikibart, and it appears to have found the perfect partner in Simcere Pharmaceutical Group, which gains exclusive rights to develop, manufacture and commercialize rademikibart in China in a deal worth $120 million plus royalties.
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