NuoSiLanDe Announces Topline Results from Phase III Trial of NL003 Gene Therapy for Rutherford Class 5 Critical Limb Ischemia with Ulceration

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On the evening of February 1, Northland announced that the company's innovative gene therapy drug under development, "Recombinant Human Hepatocyte Growth Factor Naked Plasmid Injection" (Project Code: NL003), used for treating Rutherford Stage 5 (ulcer) severe lower limb ischemic disease, has completed unblinding in its Phase III clinical trial (Ulcer Trial) and obtained preliminary analysis results of the main data.

The results showed that: In terms of the complete ulcer healing rate for the primary efficacy endpoint, the NL003 treatment group was significantly superior to the placebo group, with a statistically significant difference between the two groups (p<0.0001); in terms of safety, no serious adverse reactions related to the drug were found, demonstrating good safety, and the main outcomes met expectations.

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Reference: Company Announcement