Bristol-Myers Squibb (BMY.US) Announces Breakthrough Data on New Small Molecule Drugs

The Zhitong Finance App learned that on June 12, Bristol-Myers Squibb (BMY.US) announced the positive results of the key phase 3 trial of POETYK PsA-1 (IM011-054). This trial aims to evaluate the efficacy and safety of clexitinib deuterium in adult patients with active psoriatic arthritis who have not previously received biologic antirheumatic drugs (BdMard). The trial reached the main end point, that is, at 16 weeks of treatment, the ACR20 (at least 20% improvement in disease signs and symptoms) response rate of patients treated with deuterocloxitinib was significantly higher than in the placebo group (54.2% vs. 34.1%, respectively).

During the 16-week treatment period, the safety characteristics of deuterocloxitinib were consistent with the results observed in previous clinical trial programs, including the phase 3 POETYK PsA-2 trial and the phase 3 clinical trial for moderate to severe plaque psoriasis. Deuterocloxitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. It is also a representative class of novel small-molecule drugs, and is undergoing clinical trials for various immune-mediated diseases.

Scientists at Bristol-Myers Squibb designed deuterium clexitinib to selectively target TYK2 to inhibit IL-23, IL-12, and IFN signaling, and these cytokines are key cytokines involved in the pathogenesis of various immune-mediated diseases. Deuterocloxitinib achieves high selectivity by combining it with the regulatory domain of TYK2, contributing to the inhibition of modification of TYK2 and its downstream functions. Within physiological concentrations, deuterium clexitinib selectively inhibits TYK2. At therapeutic doses, deuterocloxitinib does not inhibit JAK1, JAK2, or JAK3. Deuteroclavitinib has been approved in many countries and regions around the world to treat adult patients with moderate to severe plaque psoriasis.