KEYMED BIO-B (02162) has announced that the Phase II clinical study of its independently developed Class 1 new drug, CM512 injection, for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) has completed data unblinding and preliminary statistical analysis.
The results indicate that CM512 met all study endpoints, with comparable efficacy across all dose groups. The drug exhibited rapid onset of action, quickly reducing nasal polyp size and significantly improving nasal congestion as early as the fourth week of treatment, while also promoting the recovery of olfactory function. A single dose maintained efficacy for six months, with the 24-week nasal polyp score (NPS) showing a significant improvement from baseline compared to the control group, along with a noticeable reduction in overall sinonasal inflammation.
In patients with CRSwNP, all dose groups of CM512 demonstrated a favorable safety and tolerability profile, with a very low incidence of anti-drug antibodies (ADA). The rate of treatment-emergent adverse events (TEAEs) was comparable to the placebo group, and no serious adverse events were reported in the CM512 group. Detailed data will be further disclosed in international academic journals or at academic conferences in the future.
Based on these Phase II results, the company is rapidly initiating the Phase III clinical study of CM512 injection for the treatment of CRSwNP, with a confirmed dosing regimen of 300 mg administered once every 24 weeks (Q24W).
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