Keymed Biosciences Inc. announced that Phase II clinical study of its self-developed Class1 innovative drug CM310 recombinant humanized monoclonal antibody injection (hereinafter refered to as CM310) for the treatment of chronic sinusitis with nasal polyps CM310NP001 has completed the analysis of unblinded data and preliminary statistics, and achieved the primary endpoints of the entire trial with positive results. CM310NP001 is a multi-center, randomized, double-blind, placebo-controlled,multiple subcutaneous clinical trial to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of CM310 recombinant humanized monoclonal antibody injection in patients with chronic sinusitis with nasal polyps. 56 eligible subjects enrolled in this study, and were randomized in a 1:1 ratio to receive 8 doses of 300 mg CM310 Q2W and placebo (Q2W).

The co-primary efficacy endpoints were the changes from baseline in bilateral nasal endoscopic polyp score (NPS) and nasal congestion score (NCS) at week 16 during treatment period. Topline result of this trial are positive with co-primary efficacy endpoints fully achieved: NPS and NCS at week 16 in CM310 group reduced 2.32 and 1.23 from baseline, respectively, which were significantly superior than those in placebo (decreased by 0.19 and 0.30, respectively, both p-values <0.0001). Meanwhile, CM310 continued to show a promising safety profile in this study.

The incidence of treatment-emergent adverse events (TEAE) in CM310 group was comparable to that of placebo. No Grade 3 and above TEAE occurred and all of TEAEs were transient and the subjects recovered without any medical intervention.