Innovo Therapeutics Inc. has announced promising results from its Phase 2 clinical trial for INV-001, an innovative treatment for post-thyroidectomy scars.
The trial, conducted across four hospitals in Korea, including Severance Hospital in Seoul, involved 77 patients with thyroidectomy wounds larger than 3 cm. Participants applied INV-001 twice daily for 12 weeks, with efficacy evaluated at the end of the treatment period using the Patient and Observer Scar Assessment Scale (POSAS).
Key findings include:
- Efficacy: INV-001, at both low (0.2%) and high (2%) doses, was found to be safe and well-tolerated, with no serious adverse events reported. In the high-dose (2%) group, there was a statistically significant 24.5% reduction in scar size compared to placebo (p<0.05, ANCOVA). The primary endpoint, Overall Opinion score on the POSAS Observer scale, showed lower scores in the treatment groups relative to placebo, with significant improvement in the high-dose group.
- Secondary Endpoints: Scar improvement trends were noted at 3 and 6 weeks, though not statistically significant. However, the high-dose group exhibited increasing improvement over time, with POSAS Patient scale scores showing notable differences from the placebo and meeting the Minimal Clinically Important Difference (MCID) of 0.39.
- Pharmacokinetics: Average blood concentrations of INV-001 in the high-dose group remained below 3.6 ng/mL throughout the 12 weeks.
- Safety: All adverse drug reactions were mild and site-specific, with no serious adverse events or serious adverse drug reactions reported.
Professor Won-Jae Lee from Yonsei University Severance Hospital, the study’s lead investigator, highlighted the trial as the first to demonstrate the scar-reducing effects of HSP47 inhibition. He emphasized the potential impact of INV-001 in filling the gap for specialized scar treatment options.
Dr. Hee Dong Park, CEO of Innovo Therapeutics, praised the trial’s results, noting INV-001’s potential to offer significant value in scar treatment due to its novel mechanism.
About INV-001: INV-001 targets HSP47, a crucial protein in collagen production and secretion, to prevent and treat scars resulting from surgery and trauma. Previous animal studies have shown its effectiveness in reducing scars without hindering wound healing.
About Innovo Therapeutics: Headquartered in South Korea, Innovo Therapeutics focuses on developing small molecules for metabolic, inflammatory, and cancer-related conditions. The company uses its AI platform, DeepZema®, to advance its drug discovery and development efforts.
