Innovo Therapeutics Announces Positive Phase 1 Results for INV-101, a Novel Immuno-Metabolic Modulator for Autoimmune Diseases

• Demonstrated strong safety and favorable pharmacokinetics in Phase 1 study
• A First-in-class oral small molecule modulating immune cell metabolism via glycogen phosphorylase inhibition
• Once-daily oral administration with high patient convenience
• Broad development potential in ulcerative colitis and other autoimmune diseases

Innovo Therapeutics Inc., a biotech company developing treatments for inflammation, fibrosis, and oncology, today announced the successful completion of a Phase 1 clinical trial for INV-101, a novel oral immuno-metabolic modulator targeting glycogen phosphorylase (GP), in healthy volunteers in the United States. INV-101 selectively controls inflammation by disrupting energy metabolism in hyperactivated immune cells.

The randomized, double-blind, placebo-controlled study enrolled 48 healthy adult participants and demonstrated an excellent safety and tolerability profile across all dose cohorts, with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs). Pharmacokinetic data also supported once-daily dosing with 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. 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.”

About INV-101

INV-101 is a first-in-class oral small molecule that selectively inhibits glycogen phosphorylase, disrupting the metabolic reprogramming of pro-inflammatory immune cells. This novel mechanism enables targeted suppression of inflammation while preserving systemic immune function. INV-101 has demonstrated target engagement and immune-metabolic modulation in multiple preclinical models. Innovo Therapeutics plans to submit an IND application to the U.S. FDA and initiate a global Phase 2 study in the first half of 2026. The Phase 1 clinical trial of INV-101 was supported by the Korea Drug Development Fund (KDDF).

About Innovo Therapeutics Inc.

Innovo Therapeutics Inc. is a South Korea–based biotech company focused on the development of small molecule therapies for inflammation, fibrosis, and cancer. The company has built a proprietary AI platform, DeepZema^®, to accelerate target identification and compound optimization. Innovo actively pursues global partnerships for clinical development and licensing of its pipeline assets, including INV-101.

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“INV-101 represents a new therapeutic strategy by modulating immune metabolism rather than suppressing immune responses. These Phase 1 results confirm the strong safety and oral convenience of INV-101."