Gyre Therapeutics (GYRE) H.C. Wainwright 8th Annual MASH Virtual Conference summary

Strategic direction and pipeline highlights

• Focus on anti-fibrotic mechanisms involving chronic inflammatory pathways and a de-risked R&D approach.

• Owns commercial rights to both Pirfenidone and Nintedanib for idiopathic pulmonary fibrosis.

• Pipeline includes Hydronidone (lead, phase 3), F573 (phase 2), F230 (IND approved), and F528 (IND preparation).

• Financially sustainable with $112 million in commercial sales in 2023.

Lead candidate Hydronidone: Mechanism and clinical progress

• Hydronidone, a Pirfenidone derivative, targets TGF-beta/Smad signaling and induces apoptosis in hepatic stellate cells.

• Demonstrated efficacy in preclinical models for liver fibrosis and favorable safety profile in phase 1 trials.

• Phase 2 trial in HBV-associated liver fibrosis showed significant improvement in fibrosis and liver stiffness, especially at 270 mg/day.

• No severe adverse events reported; no cases of drug-induced liver injury in published phase 2 data.

Ongoing and upcoming milestones

• Phase 3 trial in China for HBV-associated liver fibrosis completed enrollment; top-line results expected early 2025.

• NDA preparation underway in China, aiming for submission in 2025.

• U.S. phase 1 completed; protocol submission to FDA planned by end of 2024, with phase 2 enrollment targeted for 2025.