The need-to-know this morning
- Kailera Therapeutics, a U.S.-based developer of obesity drugs licensed from China, filed for an initial public offering.
- United Therapeutics said its drug Tyvaso improved lung function in patients with idiopathic pulmonary fibrosis, or IPF, achieving the primary goal of a second Phase 3 study. The company will submit an application this summer to the FDA, seeking to expand Tyvaso's approval to treat IPF. The drug is currently marketed as a treatment for pulmonary arterial hypertension.
- Viridian Therapeutics said its experimental drug elegrobart significantly reduced eye bulging compared to a placebo in a Phase 3 study that enrolled participants with thyroid eye disease, or TED. Viridian shares fell in pre-market trading because the efficacy of elegrobart, which is administered via a more convenient skin injection, was lower than what's seen with current, intravenously administered TED treatments.
artificial intelligence
AI drugmaker Insilico makes a big deal with Eli Lilly
Insilico Medicine has landed a rather hefty deal with Eli Lilly — $115 million upfront and up to $2.75 billion in milestone payments — to hand off some of its AI-discovered drug candidates for development and commercialization. And CEO Alex Zhavoronkov seems to be all aflutter over the pharma giant, STAT's Brittany Trang writes: "Lilly is better in AI than Insilico, and no other company is better in AI than us … except for these guys," he said. He did underscore that Lilly would not be acquiring Insilico, however.
The partnership will focus on optimizing scale: allowing Insilico to churn out relatively fast, lower-cost preclinical assets and letting Lilly take them the rest of the way. Notably, Insilico's pipeline webpage was updated to include a candidate targeting GLP-1 that's been out-licensed to an undisclosed partner.
Zhavoronkov, who is taking Lilly's tirzepatide, called it "the best drug ever invented by humans," adding that "Mounjaro makes me so happy every day. I want to develop the next one."
Read more.
Immunology
Biogen lupus drug improves skin clearance in mid-stage study
Biogen on Saturday reported positive results from a mid-stage study of an experimental treatment for a type of lupus that mostly affects the skin. The drug, called litifilimab, has the potential to be the first approved treatment for the condition and is one of two experimental drugs that are central to Biogen's immunology growth strategy.
In the Phase 2 study called AMETHYST, 15% of participants treated with litifilimab for 16 weeks had clear or almost clear skin compared to 3% of participants offered a placebo, as measured by a physician's disease-assessment score. The drug was well tolerated, with 75% of participants reporting mild to moderate side effects compared to 65% of participants in the placebo group.
The study investigated litifilimab as a potential treatment for cutaneous lupus erythematosus, or CLE, a type of lupus that can cause irreversible skin damage. The AMETHYST study results were presented at the annual meeting of the American Academy of Dermatology.
Biogen is conducting a Phase 3 study of litifilimab in CLE with an outcome expected in the middle of 2027. If positive, Biogen has said the drug could be approved and commercially available in 2028.
Biogen is also pursuing the development of litifilimab and a second drug, called dapirolizumab pegol, as a treatment for systemic lupus erythematosus, or SLE, the more common form of lupus that causes organ damage.
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