Innovo Therapeutics Completes Phase 1 Trial of INV-101, a First-in-Class Oral Immune Metabolism Modulator

13 May 2025 | Tuesday | News

INV-101 Shows Strong Safety and Pharmacokinetics, Paving the Way for Phase 2 Trials in Ulcerative Colitis and 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.”

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