en.Wedoany.com Reported - Insilico Medicine recently announced that its drug candidate, Rentosertib Inhalation Solution, has received clinical trial approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. This marks the 13th IND approval in the company's AI-driven pipeline. Rentosertib Inhalation Solution is designed for targeted lung delivery, aiming for rapid onset at lower doses while reducing systemic exposure and side effects, for the treatment of idiopathic pulmonary fibrosis (IPF).

This IND approval supports a Phase I study evaluating the safety, tolerability, and pharmacokinetics of Rentosertib Inhalation Solution. The study is divided into two parts: a randomized, double-blind, placebo-controlled single ascending dose and multiple ascending dose trial in healthy subjects, and an open-label, multiple-dose evaluation in IPF patients, with a total of approximately 80 subjects expected to be enrolled.

Dr. Feng Ren, Co-CEO and Chief Scientific Officer of Insilico Medicine, stated: "We are very pleased to receive IND approval from the CDE for Rentosertib Inhalation Solution. In previous clinical studies, oral Rentosertib demonstrated good tolerability and a dose-dependent efficacy trend. The inhalation solution is specifically designed for pulmonary delivery, aiming to optimize the benefit-risk ratio. We are simultaneously advancing the oral Rentosertib program, with the potential to initiate a Phase III trial in the second half of this year."

Preclinical studies have shown that Rentosertib Inhalation Solution can achieve high lung exposure with low systemic exposure and demonstrated anti-fibrotic and anti-inflammatory effects in animal models. Dr. Alex Zhavoronkov, founder and CEO of Insilico Medicine, pointed out that this approval validates the sustainability and reproducibility of the company's AI-driven drug discovery process. Insilico Medicine has established collaborations with multiple companies including Eli Lilly and Sanofi. From 2021 to 2024, over 20 nominated drug candidates took an average of only 12 to 18 months from project initiation to preclinical candidate nomination.

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