Shanghai Qilu Pharmaceutical Research and Development Centre Ltd. has described nonreceptor tyrosine-protein kinase TYK2 inhibitors reported to be useful for the treatment of psoriasis, asthma, type 1 diabetes, inflammatory bowel disease, gout, multiple sclerosis, rheumatoid arthritis and TNF receptor-associated periodic syndrome (TRAPS), among others.
Shares in Inventiva SA (Paris:IVAA) fell about 18% after development partner Abbvie Inc. quit development of the inflammatory disease drug cedirogant following an unfavorable readout from a phase II toxicology study. The companies had worked on the asset together for about a decade. Inventiva emerged from Abbott in 2012, before the healthcare giant split in 2013 to form pharma specialist Abbvie and Abbott Laboratories, focused on medical devices.
Immunic Inc. plans to forge ahead with oral psoriasis therapy IMU-935 despite stock-punishing results from a phase Ib trial that showed a higher placebo response than expected. Shares of the New York-based firm (NASDAQ:IMUX) closed at $2.08, down $7.12, or 77.4% after findings were made public from a preplanned interim group-level data analysis of the ongoing experiment, which is testing patients with moderate to severe disease. The group averages for Psoriasis Area and Severity Index (PASI) reductions in the two active arms failed to separate from placebo at four weeks, Immunic said. Although the active arms performed as intended, placebo decreases in PASI proved greater than hoped.
Positive phase I data from Dice Therapeutics Inc. with DC-806 in psoriasis sent shares (NASDAQ:DICE) on a wild ride, closing at $40, up $15.35, or 62%, on Oct. 11, 2022, and bolstered the case for oral drugs in psoriasis – an increasingly busy indication where discouraged patients often find themselves switching between therapies.
Sironax Ltd. has patented receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitors reported to be useful for the treatment of ulcerative colitis, Crohn's disease, psoriasis, rheumatoid arthritis, amyotrophic lateral sclerosis, Alzheimer's disease and viral infections.
The U.S. FDA has become the first global regulator to approve Boehringer Ingelheim GmbH’s spesolimab, the first treatment specifically approved for generalized pustular psoriasis flares in adults, a rare and potentially fatal disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection. Ingelheim, Germany-based Boehringer Ingelheim is not giving away details about pricing but Carinne Brouillon, a member of the company’s board responsible for human pharma, said Spevigo is “priced similarly to the other biologic therapies used to treat rare dermatologic diseases.”
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
Bristol Myers Squibb Co. has announced long-term data from its closely watched psoriasis pill, deucravacitinib, which it hopes will supplant Amgen Inc.’s blockbuster, Otezla (apremilast), as the main oral therapy for the disease.
The twos have it as the U.S. FDA’s Office of Prescription Drug Promotion, in its second untitled letter of the year, took Bausch Health Cos. Inc. to task over two promotions of its plaque psoriasis lotion, Duobrii (halobetasol propionate and tazarotene).
