- INV-001 demonstrates good safety and tolerability.
- At week 12, 2% dose group showed a 24.5% scar reduction compared to placebo.
- The first clinical trial to confirm the efficacy of INV-001 on inhibiting HSP47.
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:
- Primary Endpoint: The primary efficacy endpoint was the Overall Opinion score on the POSAS: Observer scale at 12 weeks. A trend of lower scores was observed in each treatment group compared to the placebo. Additionally, the within-group score change from baseline to 12 weeks was statistically significantly reduced in the high-dose (2%) treatment group.
- Secondary Endpoints: In the secondary efficacy evaluation, there was a trend of scar improvement at 3 and 6 weeks, but no statistically significant differences were observed. In the high-dose (2%) treatment group, a gradual improvement effect was observed, and the difference in scar improvement compared to the placebo increasing over time. The POSAS Patient scale scores also showed a trend of improvement at 3, 6, and 12 weeks, and the differences between the placebo and the low-dose (0.2%) and high-dose (2%) treatment groups were greater than the MCID (Minimal Clinically Important Difference) of 0.39, indicating clinically significant differences.
- Pharmacokinetic analysis results: The average blood concentration of INV-001 in the high-dose (2%) treatment group was measured at below 3.6 ng/mL at the 3-week, and this concentration remained similar at the 6-week and 12-week.
- Safety Results: Safety evaluations revealed all reported adverse drug reactions (ADRs) were predictable and related to the application site of the clinical trial drug, with no serious adverse events (SAEs) or serious ADRs (SADRs).
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
Post Views: 4,553
- INV-001 demonstrates good safety and tolerability.
- At week 12, 2% dose group showed a 24.5% scar reduction compared to placebo.
- The first clinical trial to confirm the efficacy of INV-001 on inhibiting HSP47.
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:
- Primary Endpoint: The primary efficacy endpoint was the Overall Opinion score on the POSAS: Observer scale at 12 weeks. A trend of lower scores was observed in each treatment group compared to the placebo. Additionally, the within-group score change from baseline to 12 weeks was statistically significantly reduced in the high-dose (2%) treatment group.
- Secondary Endpoints: In the secondary efficacy evaluation, there was a trend of scar improvement at 3 and 6 weeks, but no statistically significant differences were observed. In the high-dose (2%) treatment group, a gradual improvement effect was observed, and the difference in scar improvement compared to the placebo increasing over time. The POSAS Patient scale scores also showed a trend of improvement at 3, 6, and 12 weeks, and the differences between the placebo and the low-dose (0.2%) and high-dose (2%) treatment groups were greater than the MCID (Minimal Clinically Important Difference) of 0.39, indicating clinically significant differences.
- Pharmacokinetic analysis results: The average blood concentration of INV-001 in the high-dose (2%) treatment group was measured at below 3.6 ng/mL at the 3-week, and this concentration remained similar at the 6-week and 12-week.
- Safety Results: Safety evaluations revealed all reported adverse drug reactions (ADRs) were predictable and related to the application site of the clinical trial drug, with no serious adverse events (SAEs) or serious ADRs (SADRs).
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
Post Views: 4,553
