Infinity Pharmaceuticals, Inc., a biopharmaceutical company focused on developing small molecule medicines that target disease pathways in difficult-to-treat diseases, recently announced clinical findings from a Phase II study, dubbed ASPIRA. The trial evaluated the efficacy of Duvelisib in patients with rheumatoid arthritis.
Specifically, ASPIRA is double-blind, randomized, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety and pharmacokinetics of duvelisib dosed at either 0.5 mg, 1.0 mg or 5.0 mg twice daily (BID) for 12 weeks, with background methotrexate, compared to treatment with placebo plus methotrexate.
A total of 322 patients with moderate to severe Rheumatoid Arthritis were enrolled and treated with methotrexate. The ASPIRA primary endpoint was to test the response rate according to ACR20 at 12 weeks. ACR20 is the American College of Rheumatology (ACR) response criteria after 12 weeks of a drug treatment, and stipulates that clinical improvements should be observable in at least 20% of the patients to achieve efficacy.
However, the results reported by Infinity Pharmaceuticals revealed that duvelisib was unable to meet the ACR20. Compared to placebo, duvelisib was not successful in reaching the primary endpoint at any of the three dose levels tested. The majority of side effects observed were Grade 1-2 and deemed reversible or clinically manageable. No new safety signals associated with duvelisib therapy were identified. Data for the ASPIRA clinical trial is still under analysis, and Infinity expects to submit these findings in a peer-reviewed forum.
Based on the reported results, the company stated that they will not continue trials for the development of PI3K inhibitors in rheumatoid arthritis. Still, the company disclosed plans to test duvelisib in patients with haematological cancers, including indolent non-Hodgkin lymphoma, and chronic lymphocytic leukemia.
Infinity Pharmaceuticals, Inc. and AbbVie, Inc. are jointly developing Duvelisib as a potential cancer treatment based on the evidence that the PI3K pathway plays a role in regulating the growth and survival of tumour cells by inhibiting PI3K-delta and PI3K-gamma signaling. Duvelisib is being examined in 3 trials, involving patients with refractory indolent non-Hodgkin lymphoma, previously treated follicular lymphoma, and relapsed/refractory chronic lymphocytic leukemia.
In other developments on rheumatoid arthritis, Zydus Cadila launched the world’s first biosimilar of Adalimumab (Enbrel), the largest selling therapy in the world. This event increases the possibility that the up to 12 million people with immune disorders such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and Ankylosin Spondylitis in India will to have access to treatment.