Innovo Therapeutics Inc. Announces Phase 2 Clinical Results Demonstrating the Innovative Efficacy of INV-001 for the Treatment of Post-thyroidectomy Scars
August 20 2024 - 10:38PM
Business Wire
- 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.
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®.
This press release summarizes the clinical trial results of
INV-001, which are expected to have a significant impact on the
scar treatment market. For more information, please contact the
provided details.
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Jongkeun Jeong Innovo Therapeutics Inc. +82-2-6956-8680
invipr@innovothera.com