Innovo Therapeutics has successfully completed a Phase 1 clinical trial for INV-101, its novel oral immuno-metabolic modulator designed to treat autoimmune diseases. The study, conducted in the United States with 48 healthy adult volunteers, demonstrated strong safety outcomes and favorable pharmacokinetic properties that support once-daily dosing.
The randomized, double-blind, placebo-controlled trial showed an excellent safety and tolerability profile across all dose cohorts, with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) reported. The pharmacokinetic data revealed favorable systemic exposure, suggesting the potential for convenient outpatient administration without the need for routine monitoring.
"INV-101 represents a new therapeutic strategy by modulating immune metabolism rather than suppressing immune responses," said Dr. Hee-Dong Park, CEO of Innovo Therapeutics. "These Phase 1 results confirm the strong safety and oral convenience of INV-101 and serve as a critical foundation for advancing into global Phase 2 trials."
Novel Mechanism of Action
INV-101 is a first-in-class oral small molecule that selectively inhibits glycogen phosphorylase (GP), a key enzyme involved in cellular energy production. This inhibition disrupts the metabolic reprogramming of pro-inflammatory immune cells, effectively controlling inflammation without compromising overall immune function.
Unlike conventional immunosuppressive therapies that broadly dampen immune responses and can leave patients vulnerable to infections, INV-101's targeted approach may offer a more selective method of controlling autoimmune inflammation while preserving normal immune surveillance.
The drug has demonstrated target engagement and immune-metabolic modulation in multiple preclinical models prior to entering human trials.
Development Timeline and Therapeutic Potential
Innovo Therapeutics, a South Korea-based biotech company, plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration and initiate a global Phase 2 study in the first half of 2026.
The company is positioning INV-101 for broad development potential in ulcerative colitis and other autoimmune diseases. The oral administration route offers significant advantages over injectable biologics currently dominating the autoimmune treatment landscape, potentially improving patient convenience and compliance.
"We are committed to developing INV-101 as a new treatment option that can offer stable, long-term relief for patients living with autoimmune diseases," Dr. Park added.
Company Background and Support
Innovo Therapeutics focuses on developing small molecule therapies for inflammation, fibrosis, and cancer. The company has built a proprietary AI platform called DeepZema® to accelerate target identification and compound optimization.
The Phase 1 clinical trial of INV-101 was supported by the Korea Drug Development Fund (KDDF), highlighting the collaborative approach to advancing this novel therapeutic. Innovo actively pursues global partnerships for clinical development and licensing of its pipeline assets, including INV-101.
As autoimmune diseases continue to affect millions worldwide with limited long-term treatment options, INV-101's novel mechanism and promising early results position it as a potential breakthrough in addressing the underlying metabolic drivers of immune dysregulation rather than merely suppressing symptoms.
