SEOUL, South Korea—Innovo Therapeutics Inc., a biotech company dedicated to developing treatments for inflammation, fibrosis, and oncology, has announced positive results from a Phase 1 clinical trial of its novel oral immuno-metabolic modulator, INV-101. The drug targets glycogen phosphorylase (GP) to selectively control inflammation by disrupting the energy metabolism of hyperactive immune cells. "We are thrilled with the Phase 1 results for INV-101," said Dr. Hee-Dong Park, CEO of Innovo Therapeutics. "By modulating immune metabolism rather than suppressing immune responses, INV-101 represents a groundbreaking therapeutic approach. The findings confirm its strong safety profile and convenient oral administration, paving the way for global Phase 2 trials. Our commitment is to develop INV-101 as a long-term, stable treatment option for patients suffering from autoimmune diseases." The Phase 1 clinical trial was a randomized, double-blind, placebo-controlled study involving 48 healthy adult participants. The trial demonstrated excellent safety and tolerability across all dose cohorts, with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs). Pharmacokinetic data further supported the feasibility of once-daily dosing, indicating favorable systemic exposure and the potential for convenient outpatient use without routine monitoring. INV-101 is a first-in-class small molecule that selectively inhibits glycogen phosphorylase, thereby disrupting the metabolic reprogramming of pro-inflammatory immune cells. This innovative mechanism allows for targeted inflammation suppression while maintaining systemic immune function. Preclinical studies have already shown promising results, with consistent target engagement and effective immune-metabolic modulation. Building on these positive outcomes, Innovo Therapeutics intends to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) and to initiate a global Phase 2 study by the first half of 2026. The Phase 1 trial of INV-101 was financially supported by the Korea Drug Development Fund (KDDF). Innovo Therapeutics Inc. is a leading South Korea-based biotech company focused on the discovery and development of small molecule therapies for various conditions, including inflammation, fibrosis, and cancer. The company utilizes its proprietary AI platform, DeepZema®, to expedite the process of identifying targets and optimizing compounds, thus enhancing the efficiency of drug development. Innovo is actively seeking global partnerships to advance the clinical development and licensing of its pipeline assets, such as INV-101, to bring innovative treatments to patients worldwide. For more updates on Innovo Therapeutics' research and developments, stay tuned for additional news releases.