SEOUL, South Korea I August 21, 2024 I
Innovo Therapeutics Inc.
has announced the results of its Phase 2 clinical trial demonstrating the innovative efficacy of INV-001 in scar treatment.
The trial involved 77 Korean patients with wounds larger than 3 cm following thyroidectomy, conducted at four general hospitals including Severance Hospital in Seoul. Patients were randomly assigned within 14 days post-surgery to apply INV-001 twice daily for 12 weeks, with efficacy assessed at week 12 using the POSAS (Patient and Observer Scar Assessment Scale).
The trial confirmed both the safety and tolerability of INV-001 at both low (0.2%) and high (2%) doses, with no serious adverse events (SAEs) reported. In the group that received the clinical drug at a high (2%) dose for 12 weeks without major protocol violations, a statistically significant difference (p<0.05, ANCOVA; Analysis of Covariance) was observed compared to the placebo, with a 24.5% reduction in scars at week 12, as confirmed through per-protocol set.
Key Findings:
Professor Won-Jae Lee, the Coordinating Investigator and a plastic surgeon at Yonsei University Severance Hospital, mentioned that this clinical trial is the first globally to confirm the scar suppression effects of HSP47 inhibition. He emphasized that the proven scar reduction effects of INV-001 are highly encouraging. Additionally, he noted that, given the current lack of specialized topical medications for scar suppression, the development of a specialized ointment based on this clinical trial would be welcomed by both clinicians and patients.
Dr. Hee Dong Park, a founder and CEO of Innovo Therapeutics, stated that this clinical trial confirmed the safety and efficacy of INV-001, highlighting its potential as a scar treatment. He also noted that its innovative mechanism promises to deliver real value to patients in the scar treatment market.
About INV-001:
INV-001 inhibits HSP47, a key protein in collagen formation, transport, and extracellular secretion, thereby preventing and treating post-surgical and trauma-induced scars. Results from disease animal models have confirmed that INV-001 effectively inhibits trauma-induced scars without affecting wound healing.
About Innovo Therapeutics:
Innovo Therapeutics, Inc., headquartered in South Korea, is a biotechnology company primarily focused on developing small molecules for metabolic, inflammatory, and cancer diseases. The company is actively discovering new drug candidates and optimizing research through its AI platform, DeepZema®.
SOURCE:
Innovo Therapeutics