Bristol-Myers' psoriasis drug proves itself in mid-stage study
- An experimental psoriasis medicine developed by Bristol-Myers Squibb hit its goal in a mid-stage study, reinforcing the company's designs to play a greater role in the growing market for immune-mediated diseases.
- Data published Wednesday in the New England Journal of Medicine showed treatment with the drug, an oral kinase inhibitor, resulted in significantly more patients achieving a specified level of skin clearance than did those given placebo. The findings raise confidence in the treatment, which is currently in Phase 3 testing.
- Best known for its efforts in cancer, Bristol-Myers trails rivals like J&J, Novartis and AbbVie in developing new, more potent options for diseases like plaque psoriasis. Success with this treatment could help change that.
Unlike some of the recently approved psoriasis drugs that target certain proteins called interleukins, Bristol-Myers' experimental treatment is designed to block what's known as tyrosine kinase 2 (TYK2).
Cellular signals transmitted through TYK2 are thought to trigger several other signaling pathways, including IL-12 and IL-23, that are behind the chronic inflammation characteristic of immune-mediated conditions like plaque psoriasis.
In theory, blocking activation of TYK2 can shut down those signals and help tamp down disease. Wednesday's results should help Bristol-Myers make that case more strongly.
The Phase 2 study tested five doses of the drug, dubbed BMS-986165, against placebo in 267 patients with moderate-to-severe plaque psoriasis. Results showed a dose-dependent improvement in response, with between 67% and 75% of patients in the higher dose groups achieving a 75% or greater reduction in a measure of disease severity known as PASI.
Notably, a quarter of the 44 patients who received the highest dose of Bristol-Myers' drug experienced 100% skin clearance. No one in the placebo group saw such a complete response.
On safety, treatment led to a higher rate of side effects than did placebo, although the most frequent were common cold, headache and diarrhea. Three serious adverse events, including one accidental eye injury, were reported in the treatment groups, compared to two in the placebo cohort.
Bristol-Myers is currently enrolling two Phase 3 studies of BMS-986165 in moderate-to-severe plaque psoriasis, with primary completion for both set for mid-2020. Other earlier studies in lupus and Crohn's disease are also ongoing.
Further success in the clinic could make Bristol-Myers' drug a competitor to new treatments like Novartis' Cosentyx (secukinumab), J&J's Tremfya (guselkumab) or AbbVie's experimental drug risankizumab.
Many of its potential competitors, however, are antibodies, giving BMS-986165' oral formulation a competitive edge.
"Currently, patients with moderate to severe psoriasis have a limited number of oral therapies," said Kim Papp, lead study author, in a statement released Wednesday by Bristol-Myers.
Yet, Bristol-Myers isn't alone in exploring TYK2 inhibition. Pfizer has a compound in Phase 2 for plaque psoriasis, ulcerative colitis and Crohn's, while Celgene recently inked a research deal with Nimbus Therapeutics that gives it an option to acquire a preclinical TYK2 blocker.
- New England Journal of Medicine Phase 2 Trial of Selective Tyrosine Kinase 2 Inhibition in Psoriasis
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