Insilico’s lead drug meets safety and efficacy goals in IPF study

Insilico Medicine, a biotechnology company with offices in China and the United States, announced this week that its lead drug candidate met its primary safety endpoint and secondary efficacy endpoints.

INS018_055 (also known as ISM001-055) is a small molecule drug candidate targeting TRAF2 and NCK-interacting kinase (TNIK). TNIK inhibitors are being investigated for potential anti-cancer properties, but are also believed to possess antifibrotic properties that could be effective in treating lung diseases such as idiopathic pulmonary fibrosis (IPF).

The Phase 2a study INS018_055/ISM001-055 enrolled 71 patients with IPF in China who were randomly assigned to receive either placebo, 30 mg once daily, 30 mg twice daily, or 60 mg once daily for 12 weeks. A similar Phase 2a study is currently recruiting patients in the United States.

In a statement released this week, the company said its therapy candidate met its primary endpoint of safety and tolerability at all doses. It also said secondary efficacy endpoints were also met, with the greatest improvement in forced vital capacity (FVC) seen at the highest dose of 60 mg once daily. The company will now plan a Phase 2b trial in consultation with regulators.

Notably, Insilico has not yet released full data from the trial, making it difficult to assess the potential therapy's level of effectiveness. It said in a press release that full topline data would be released at an upcoming medical conference and that clinical trial results would be submitted for publication in a peer-reviewed journal.