Basel, Switzerland — August 11, 2025 — Leads & Copy — FoRx Therapeutics, a clinical-stage biotechnology company, has announced the dosing of the first patient in a first-in-human clinical study of FORX-428, a novel PARG inhibitor targeting the DNA Damage Response (DDR) in advanced solid tumors. The trial is initially taking place in the U.S., following IND clearance, with initial data expected in mid-2026 from an open-label Phase 1 study. This marks a milestone in the company’s drive to redefine cancer treatment with precision oncology therapy.
The company is pursuing a next-generation DDR target, called PARG, seeking to further advance the strategy of interfering with the DDR. PARG inhibition holds promise for patients whose cancers do not respond to PARP inhibitors.
CEO of FoRx Therapeutics, Tarig Bashir, said that FORX-428 has demonstrated anti-tumor efficacy in preclinical in vivo tumor models, suggesting best-in-class potential. Manish R. Sharma, MD, Co-Director of Clinical Research at START Midwest and Principal Investigator on the trial, added that there is an unmet need to develop new therapies for advanced cancer patients with distinct DNA damage repair deficiencies or high replication stress.
FORX-428 received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) on June 13, the first patient first visit (FPFV) was on July 22 and the first patient was dosed on August 6.
FORX-428 is a proprietary, orally available small molecule drug designed to inhibit poly (ADP-ribose) glycohydrolase (PARG) to cause tumor cell death. FoRx Therapeutics is a privately held clinical-stage biotechnology company pioneering precision therapeutics targeting the DNA Damage Response in treatment-resistant cancers.
Tarig Bashir, CEO of FoRx Therapeutics, info@forxtherapeutics.com, +41 79 367 6254
