Innovo Therapeutics Announces Phase 2 Clinical Results Demonstrating the Innovative Efficacy of INV-001 for Scar Treatment After Thyroidectomy

InnoVothera Therapeutics, which is developing treatments for metabolic, inflammatory, and cancer diseases, announced on the 19th the results of a placebo-controlled, double-blind Phase 2 clinical trial demonstrating the innovative efficacy of its scar treatment ‘INV-001.’

INV-001 is a drug repositioned from InnoVothera Therapeutics’ AI drug platform, DeepZema®. By inhibiting HSP47 (Heat Shock Protein 47), an essential protein for collagen production, it enables the prevention and treatment of scars after surgery and trauma.

The clinical trial involved 77 Korean patients with wounds larger than 3 cm who had undergone thyroidectomy. The trial was conducted at four general hospitals, including Seoul Severance Hospital. Patients were randomly assigned within 14 days after thyroidectomy to apply INV-001 twice daily to the surgical site for 12 weeks. At week 12, evaluation was conducted using the primary efficacy endpoint, the POSAS (Patient and Observer Scar Assessment Scale).

The trial confirmed the safety and tolerability of INV-001 in both low-dose (0.2%) and high-dose (2%) treatment groups. No serious adverse events (SAEs) were reported during the trial. In the high-dose (2%) group, which administered the clinical drug for 12 weeks without major protocol violations, statistical significance (P<0.05, ANCOVA: Analysis of Covariance) was confirmed compared to placebo, with a 24.5% reduction in scars at week 12 compared to placebo.

In the primary efficacy evaluation, both the low-dose and high-dose treatment groups tended to have lower scores compared to the placebo group. Especially in the high-dose (2%) group, the within-group score change from baseline to week 12 was statistically significantly reduced.

Secondary efficacy evaluations were conducted using the total POSAS scores and the VSS (Vancouver Scar Scale) at each time point. Overall, there was a trend of scar improvement compared to the control group, but no statistically significant differences were confirmed. However, a progressive scar improvement effect was observed in the high-dose treatment group, and the difference in scar improvement compared to placebo gradually increased with longer administration periods. This confirms that the mechanism of action of INV-001 is the inhibition of collagen production in the early stages of scar formation.

Dr. Wonjae Lee, Coordinating Investigator and Professor of Plastic Surgery at Yonsei University Severance Hospital, stated that this clinical trial is the world’s first to confirm the scar suppression effect by inhibiting HSP47, and proving the scar reduction effect of INV-001 is very encouraging.

He also mentioned that in the absence of topical prescription drugs with scar suppression effects, if a specialized scar suppression ointment is developed based on this clinical trial, it will be welcomed by both clinicians and patients.

Heedong Park, CEO of InnoVothera Therapeutics, said, “Through this clinical trial, we confirmed the usefulness of our AI platform DeepZema, as well as the safety, efficacy, and development potential of INV-001, a topical scar treatment developed based on it.” He added, “We expect it to bring innovation to the scar treatment market and provide true value to patients.”