BMS's Sotyktu Shows Promise in Phase III Psoriatic Arthritis Trial, Faces Competitive Landscape

Bristol Myers Squibb (BMS) has reported positive late-stage results for its TYK2 inhibitor Sotyktu in psoriatic arthritis, potentially paving the way for a label expansion. The POETYK PsA-2 study demonstrated statistically significant improvements in patients treated with Sotyktu compared to placebo, marking a crucial step forward in addressing unmet needs in psoriatic arthritis treatment.

Sotyktu's Phase III Success

In the POETYK PsA-2 trial, 54.2% of patients receiving Sotyktu experienced at least a 20% improvement in signs and symptoms at 16 weeks, compared to 39.4% in the placebo group. The treatment difference was statistically significant, with a p-value of 0.0002. Sotyktu also met key secondary endpoints, showing greater improvements in clinical signs and symptoms of psoriatic arthritis, as well as enhanced disability and patient-reported outcomes compared to placebo.

Edgar Charles, Vice President and Senior Global Program Lead of Early & Late Development Immunology at BMS, stated that these findings are "promising" and highlight "the potential of Sotyktu as an oral therapy and the first TYK2 inhibitor that may be able to address significant unmet needs of patients living with psoriatic arthritis."

Sotyktu's Safety Profile and Market Position

Sotyktu, an orally available blocker of the TYK2 protein, was first approved in September 2022 for plaque psoriasis. The drug has demonstrated a cleaner safety profile compared to other JAK inhibitors, with Jonathan Sadeh, Senior Vice President of Immunology and Fibrosis Development at BMS, noting that Sotyktu's adverse event profile "is very different from the current oral standard of care and from the class of JAK inhibitors."

However, Sotyktu faces stiff competition in a crowded market. A report from Spherix Global Insights in August 2023 found that Amgen's oral drug Otezla has maintained its market share despite Sotyktu's entry. Additionally, San Francisco-based biotech Alumis is developing ESK-001, a potential rival TYK2 inhibitor, which is currently in late-stage development for moderate-to-severe plaque psoriasis and systemic lupus erythematosus.

Industry Dynamics and Future Outlook

The pharmaceutical landscape for psoriasis and psoriatic arthritis treatments continues to evolve rapidly. Alumis recently signed a merger agreement with Acelyrin to combine their resources and expertise, potentially strengthening their position in the development of ESK-001.

As BMS builds towards a potential label expansion for Sotyktu in psoriatic arthritis, the company will need to navigate a competitive market landscape. The success of Sotyktu in this new indication could significantly impact BMS's position in the immunology space, while also providing patients with a novel treatment option for psoriatic arthritis.