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.
Alys Pharmaceuticals Inc. has launched with a focus in the field of immuno-dermatology. Supported by $100 million in financing from Medicxi, Alys was formed through the aggregation of six asset-centric Medicxi companies: Aldena Therapeutics Inc., Graegis Pharmaceuticals Ltd., Granular Therapeutics Ltd., Klirna Biotech Sàrl, Nira Biosciences Inc. and Vimela Therapeutics Inc.
Guangzhou Fermion Technology Co. Ltd. has received IND approval by China’s National Medical Products Administration (NMPA) for its TYK2 JH2 inhibitor, FZ-007-119.
DP Technology Ltd. has nominated DPT-0218, a novel small molecule targeting Kv1.3, as a preclinical candidate for the treatment of various autoimmune diseases, including inflammatory bowel disease and atopic dermatitis.
Dermasensor Inc. received U.S. FDA clearance for its non-invasive skin cancer evaluation device that provides quantitative identification of all skin cancer types at the point of care and within seconds. The point-and-click device is designed to facilitate detection of skin cancers by primary care physicians (PCPs) and speed the time to diagnosis and treatment.
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.
Onquality Pharmaceuticals LLC has obtained IND clearance from the FDA for OQL-025 to treat epidermal growth factor receptor (EGFR) inhibitor-induced acneiform rash, a common toxicity affecting patients treated with EGFR inhibitor therapy for various cancers.