Innovo Therapeutics Inc. has revealed remarkable results from its Phase 2 clinical trial, demonstrating the efficacy of INV-001 in reducing post-thyroidectomy scars. This innovative treatment achieved a notable 24.5% reduction in scar size with the high (2%) dose compared to a placebo, marking a significant advancement in scar management.

The clinical trial, which involved 77 patients in South Korea, including at Severance Hospital in Seoul, was designed to evaluate INV-001’s effectiveness and safety. Patients who had undergone thyroidectomy and had wounds larger than 3 cm were treated with INV-001 twice daily for 12 weeks. Efficacy was measured using the Patient and Observer Scar Assessment Scale (POSAS). The trial’s outcomes underline INV-001’s potential to offer a new solution for scar treatment.

The primary endpoint, assessed through the Observer scale of the POSAS at 12 weeks, demonstrated a favorable trend in scar reduction for all treatment groups relative to the placebo. The high-dose (2%) group showed a statistically significant reduction in scars, with a 24.5% decrease, based on the per-protocol analysis. This result highlights INV-001’s potential as a significant breakthrough in scar management.

Secondary evaluations of the trial indicated early signs of scar improvement at 3 and 6 weeks, with more pronounced effects observed in the high-dose group over time. The POSAS Patient scale scores also reflected consistent improvement across the study period. The differences between the treatment groups and the placebo surpassed the Minimal Clinically Important Difference (MCID) of 0.39, underscoring the clinical relevance of the findings.

Pharmacokinetic analysis of INV-001 revealed that the average blood concentration in the high-dose group remained below 3.6 ng/mL throughout the 12-week period, indicating stable and low systemic exposure. Safety evaluations confirmed that all adverse drug reactions (ADRs) were localized to the application site, with no serious adverse events (SAEs) reported, highlighting the treatment’s favorable safety profile.

Professor Won-Jae Lee, the Coordinating Investigator and a plastic surgeon at Yonsei University Severance Hospital, emphasized that this trial represents the first global study to confirm the scar suppression effects of HSP47 inhibition. He praised INV-001’s demonstrated efficacy and highlighted the lack of specialized topical medications for scar management, noting that the development of INV-001 could be highly beneficial for both clinicians and patients.

Dr. Hee Dong Park, founder and CEO of Innovo Therapeutics, commented on the trial’s success, affirming that INV-001’s safety and efficacy have been validated. Dr. Park emphasized the innovative mechanism of INV-001, which offers substantial potential for the scar treatment market, reflecting the company’s commitment to advancing therapeutic solutions.

INV-001 targets HSP47, a protein crucial for collagen formation and secretion, thus preventing and treating scars resulting from surgery or trauma. Previous studies in animal models have demonstrated its effectiveness in managing scars without affecting wound healing.

Innovo Therapeutics Inc., headquartered in South Korea, is dedicated to developing small molecules for treating metabolic, inflammatory, and cancer-related diseases. The company leverages its AI platform, DeepZema, to drive drug discovery and optimization, reinforcing its role in pioneering therapeutic innovations.

  Dr. Hee Dong Park, HSP47, Innovo Therapeutics Inc., INV-001, POSAS, Professor Won-Jae Lee, Severance Hospital, South Korea, Yonsei University