Clinical studies of oral IPF treatment INS018_055 advancing in US, China
Developer Insilico now planning proof-of-concept trial to launch next year
A Phase 2a clinical trial testing the safety of treatment candidate INS018_055 among idiopathic pulmonary fibrosis (IPF) patients in the U.S. is still seeking participants, while a parallel trial in China has now completed enrollment.
That’s according to an update from Insilico Medicine, which developed the oral therapy with technology powered by artificial intelligence (AI). Both studies are mainly designed to evaluate the treatment’s safety and tolerability.
The Chinese trial (NCT05938920) has met its planned enrollment, with 71 IPF patients participating at centers across the country, while the U.S. study (NCT05975983) is aiming to enroll 60 patients, also ages 40 or older, at sites nationwide.
Data from the Chinese study are expected by the end of the year. Meanwhile, Insilico is planning the launch, in 2025, of a Phase 2b proof-of-concept trial that’s intended to further explore the efficacy of INS018_055 in IPF.
“I am excited about the clinical progress in this program,” Feng Ren, PhD, co-CEO and chief scientific officer at Insilico, said in a company press release, adding that it “marks a step forward in the validation of AI-driven drug discovery and development.
“We look forward to sharing more clinical data and evaluating INS018_055 in a proof-of-concept study soon,” Ren added.
Parallel trials testing safety, tolerability of IPF treatment
IPF is a serious and progressive lung disease characterized by scarring, or fibrosis, in the lungs that makes it progressively harder to breathe. Currently available treatments aim to slow disease progression but often fail to halt it entirely, and come with a range of side effects, according to Insilico.
INS018_055 is a small molecule that targets TNIK — TRAF2- and NCK-interacting kinase — a molecule that’s been associated with fibrosis-driving cell signaling pathways. The gene encoding TNIK has been found to have higher activity in lung cells from IPF patients compared with that seen in people without it.
As such, the company believes the oral treatment may be a first-in-class antifibrotic treatment option for IPF.
Insilico identified TNIK as a therapeutic target for IPF using its commercially available AI-powered platform PandaOmics. The company then used another AI-based platform, called Chemistry42, to design a small molecule that would target it — the one it dubbed INS018_055.
Subsequent preclinical studies showed that the investigational therapy eased lung fibrosis in a mouse model of IPF. The treatment also was generally safe and well tolerated in Phase 1 studies involving healthy adults.
The parallel Phase 2 trials involving IPF patients began dosing around this time last year. In the two studies, participants are randomly assigned to receive either of two doses of INS018_055 or a placebo, taken orally once or twice daily for three months.
We thank our clinical collaborators and participating patients and families. … Their support contributes to our understanding of the discovery and development of innovative therapies driven by AI, in this serious chronic disease.
In addition to safety, the therapy’s pharmacokinetics — its movement into, through, and out of the body — will be assessed. Changes in lung function, exercise capacity, and hospitalizations related to IPF lung exacerbations also will be monitored.
INS018_055 holds orphan drug designation in the U.S. for the treatment of IPF. This regulatory status is intended to speed the therapy’s development toward regulatory approval.
“We thank our clinical collaborators and participating patients and families for their continued interest and commitment,” said Sujata Rao, MD, Insilico’s chief medical officer. “Their support contributes to our understanding of the discovery and development of innovative therapies driven by AI, in this serious chronic disease.”
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