The FDA clinical hold follows a a report of liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.
Allakos’s lirentelimab did not beat a placebo in separate Phase 2 tests in atopic dermatitis and spontaneous chronic urticaria. A restructuring now turns the biotech’s focus to an early-stage drug candidate also designed to treat inflammation.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Despite artificial intelligence’s growing role in drug research, a fully AI-generated molecule has yet to advance from discovery all the way through clinical development. A novel molecule may eventually meet that goal, but some industry observers say it’s too early to focus on winning a race that has many twists and turns yet to come.
Available atopic dermatitis drugs work by blocking inflammation, but Triveni Bio is developing an antibody that addresses a root cause of the chronic condition. The startup is out of stealth to advance its lead program and a pipeline of other inflammation and immunology drugs.
“Botched math” in calculating clinical data for an autoimmune disease drug is one of the allegations Nektar Therapeutics makes in a legal complaint against Eli Lilly. The biotech claims its former partner tried to disadvantage the asset in order to advance development of another drug it acquired in a billion dollar deal.
Inflammation and immunology biotech Apogee Therapeutics and Sagimet Biosciences, a company developing a drug for the fatty liver disease NASH, are the latest biotech companies to join the public markets. Both companies upsized their IPOs, raising cash for clinical trials.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Apogee Therapeutics is planning an IPO to fund clinical development of biologic drugs that could offer dosing advantages over currently available immunology and inflammation drugs. Its lead program is being prepared for Phase 1 testing in atopic dermatitis, or eczema.
While most targeted protein degradation drug research has focused on cancer, Kymera Therapeutics’ Phase 1 data bring validation for this approach in treating inflammation. Kymera partner Sanofi has elected to advance the biotech’s program to mid-stage testing in two inflammatory skin disorders.
With FDA approval for its atopic dermatitis drug Adbry, LEO Pharma will reach the U.S market ahead of an Eli Lilly atopic dermatitis drug that addresses the same target. LEO will also able to offer patients an alternative to the blockbuster Sanofi/Regeneron Pharmaceuticals drug Dupixent.
Sales of blockbuster Pfizer drug Xeljanz are under pressure from a stronger safety warning placed across that drug’s entire class. In acquiring Arena Pharmaceuticals for $6.7 billion, Pfizer gets a lead compound with a different and potentially safer approach to treating inflammatory conditions.
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Atopic dermatitis patients now have a new therapeutic option that comes as a topical cream. The FDA approved Incyte’s drug, Opzelura, as a treatment for the inflammatory skin condition, but the regulatory nod comes with a black box warning on the label that broadly covers the entire class of JAK inhibitors.
Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.
Amgen is paying Kyowa Kirin $400 million to share in the development of a drug that could offer a new approach to treating atopic dermatitis, a form of eczema. The deal comes months after Japan-based Kyowa Kirin reported positive preliminary Phase 2 data for its antibody.
The company is developing abrocitinib, a JAK1 inhibitor, for the disease. Incyte is also developing a topical formulation of its JAK2 inhibitor for atopic dermatitis.
The companies also reported a European dermatitis approval and successful topline results from a Phase III study of the drug, Dupixent.