Insilico Medicine, which has facilities in the US and China, said that an IND for a Phase 1 PK trial of rentosertib (ISM001-055) inhalation solution has been cleared by the CDE. The company said that the study is expected to enroll approximately 80 subjects, with the MAD portion of the trial enrolling patients who have idiopathic pulmonary fibrosis.
In 2023, Insilico announced that it planned to submit an IND to the FDA for a Phase 1 trial of an inhaled formulation of ISM001-055, a small-molecule anti-fibrotic that is in development for the treatment of IPF. The company’s web site currently does not indicate that any previous human trials of the inhaled formulation have been conducted.
Insilico Medicine Chief Scientific Officer and co-CEO Feng Ren commented, “We are pleased to receive CDE IND approval for Rentosertib inhalation solution. In prior clinical studies, oral Rentosertib showed good tolerability, a favorable PK profile, and dose-dependent efficacy trend, strengthening our confidence in its mechanism and clinical potential. We look forward to seeing the Rentosertib inhalation solution deliver positive clinical results again in both healthy volunteers and patient populations. The inhalation solution is designed for targeted lung delivery, with the goal of achieving higher pulmonary exposure and faster onset at lower doses while reducing systemic exposure and optimizing the benefit–risk profile.”
Read the Insilico Medicine press release
