PRESS RELEASE
News Provided by
Innovo Therapeutics
June 22, 2026, 09:00 AM KST
·
Phase 2 study demonstrated a
statistically significant 24.5% reduction in scar formation versus placebo at
Week 12.
·
First-in-class HSP47-targeting
mechanism designed to inhibit excessive collagen production and scar formation.
·
Aims to address the significant
unmet need in the prescription scar treatment market.
Seoul, June 22,
2026 – Innovo Therapeutics Co., Ltd. (CEO:
Hee-Dong Park), an AI-driven drug discovery company, announced that the
Ministry of Food and Drug Safety (MFDS) of South Korea has approved the Phase 3
Investigational New Drug (IND) application for INV-001, the company’s topical
treatment for scar prevention and management.
INV-001 is a drug
repositioning-based development asset discovered through Innovo’s proprietary
AI-driven drug discovery platform, DeepZema®. The product inhibits Heat Shock
Protein 47 (HSP47), a collagen-specific molecular chaperone essential for
collagen synthesis, thereby reducing abnormal scar formation by regulating
excessive collagen accumulation and fibrosis. As a first-in-class
HSP47-targeting approach for scar prevention and treatment, INV-001 has
attracted attention as a potential new therapeutic option in a market where
approved prescription treatments with direct anti-scarring effects remain
highly limited.
The Phase 3 approval was
supported by the results of a domestic Phase 2 clinical trial completed in
August 2024. The study enrolled 77 Korean patients with post-thyroidectomy
wounds measuring at least 3 cm and was conducted at four tertiary hospitals, including
Severance Hospital, in a randomized, double-blind, placebo-controlled design.
Efficacy was evaluated using the Patient and Observer Scar Assessment Scale
(POSAS).
In the Phase 2 study, the
high-dose (2%) treatment group demonstrated a statistically significant 24.5%
reduction in scar formation compared with placebo at Week 12 (P<0.05,
ANCOVA). Both the low-dose and high-dose groups exhibited favorable safety and
tolerability profiles with no serious adverse events (SAEs). Furthermore, the
treatment effect versus placebo increased progressively over time, supporting
INV-001’s mechanism of inhibiting collagen production during the early stages
of scar formation.
The Phase 3 study will be a
multicenter, randomized, double-blind, placebo-controlled trial enrolling
approximately 252 patients undergoing thyroidectomy in South Korea. The study
will evaluate the efficacy and safety of INV-001 using POSAS-based scar assessments.
Hee-Dong Park, Chief Executive Officer of Innovo Therapeutics, commented: “The
approval of this Phase 3 study marks an important milestone in the development
of INV-001 as the world’s first HSP47-targeting prescription treatment for
scars. We are committed to successfully completing the Phase 3 program and
bringing a new therapeutic option to patients with unmet needs in scar
management, while actively pursuing opportunities in both domestic and global
markets.”
INV-001 is being developed
as a topical formulation characterized by minimal systemic exposure while
achieving high local drug exposure to skin tissue. This profile may provide
both favorable safety and convenience for long-term scar management.
Innovo Therapeutics is a
Korea-based biotechnology company focused on the discovery and development of
small-molecule therapeutics for inflammatory, fibrotic, and oncologic diseases.
Leveraging its proprietary AI-driven platform, DeepZema®, the company continues
to advance novel discovery programs and clinical development. Its inflammatory
bowel disease program, INV-101, received U.S. FDA clearance for a Phase 2 trial
in 2025. Another IBD program, INV-008, was licensed to Daewoong Pharmaceutical
in a transaction valued at KRW 662.5 billion (approximately USD 480 million),
demonstrating the commercial potential of Innovo’s AI-enabled discovery
capabilities.
Media Contact:
Kyungyoun
Hong
Innovo
Therapeutics Inc.
+82-2-6956-8680
kyhong@innovothera.com