Dive Brief:
- An experimental anti-inflammatory drug being developed by Belgium-based Galapagos met its main goal in one Phase 2 clinical trial but missed in another, the company said Thursday.
- The drug, which blocks an inflammation-signaling enzyme called TYK2, helped significantly improve disease signs and symptoms in people with a muscle and skin condition called dermatomyositis. But it didn’t help people with lupus, missing statistical significance on a broad measure of clinical response.
- Called GLPG3667, the drug is Galapagos’ biggest remaining asset following a decision to wind down the company’s cancer cell-therapy business after an unsuccessful attempt to sell it. Galapagos may seek a partner to help further develop GLPG3667, which has some competition in the form of a Roivant medicine that could be under Food and Drug Administration review for dermatomyositis early next year.
Dive Insight:
Research into TYK2-blocking agents has been stimulated by the clinical success of Bristol Myers Squibb’s Sotyktu, which in 2022 became the first drug in the class to gain approval. This type of therapy provides an oral alternative to the injectable biologics often used in autoimmune disorders like psoriasis, a condition for which Sotyktu is approved.
Other companies active in developing TYK2 drugs include Takeda Pharmaceutical, which reported positive psoriasis data earlier this week, as well as Alumis, Spain-based Oncostellae and startup Neuron23.
Bristol Myers recorded $206 million in Sotyktu sales over the first nine months of 2025, a 26% increase from the same period in 2024.
Galapagos and Roivant are being helped by Bristol Myers having no immediate plans to advance Sotyktu in dermatomyositis, choosing to expand instead into lupus and Sjögren's syndrome. A National Institutes of Health Phase 2 trial of Sotyktu in dermatomyositis has been withdrawn because Bristol Myers stopped supplying the pills.
Dermatomyositis is an autoimmune condition that causes severe rash and muscle weakness and can lead to heart and lung problems. It is now treated with steroids, other immune-suppressing drugs like methotrexate and, in severe cases, intravenous infusions of donor-derived antibodies. In its trial, Galapagos set a goal of improving patients’ scores on a scale that measures biological disease markers, patients' symptoms and overall disease activity.
Compared to enrollees who got a placebo, those on GLPG3667 for 24 weeks scored more than 14 points better, a statistically significant difference as measured under the trial’s pre-specified plan. That is similar to the 15-point difference seen with Roivant’s trial of brepocitinib after 52 weeks, although the two drugs haven’t been tested against each other.
With the dermatomyositis data in hand, Galapagos is “evaluating all strategic options,” CEO Henry Gosebruch said in a statement. “These include resuming potential partnering discussions announced earlier this year to accelerate development in dermatomyositis, as well as exploring opportunities to expand into other severe autoimmune diseases with significant unmet medical need.”
Longtime collaborator Gilead Sciences has waived certain rights to the drug, enabling Galapagos to seek partners.
While viewing the dermatomyositis data as positive, Wall Street analysts said they doubt the drug will move forward solely under Galapagos’ banner.
The company has “suggested to us that its bar to develop '3667 and further invest in the program itself remains high,” wrote T.D. Cowen analyst Phil Nadeau, in a note to clients. Given the mixed Phase 2 data and Gilead temporarily waiving its rights, “we expect '3667 will likely advance further only if a partner can be found.”
