Rila Therapeutics has dosed the first cohort of subjects in a Phase I clinical trial of RLA-23174, a potential treatment for chronic kidney disease (CKD) and fibrosis, in China.

The dosing was carried out in partnership with Yingli Pharmaceutical, Rila’s development partner.

The single-centre, placebo-controlled study will assess the tolerability, safety at varying dose levels, food effect, and pharmacokinetics of RLA-23174.

Enrolment of healthy subjects is underway in the trial, which will have staggered single ascending dose and multiple ascending dose cohorts.

Up to 80 subjects will be enrolled in the trial.

This Phase I trial is anticipated to conclude by the third quarter of this year to support the progression into the Phase II clinical programme.

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The mechanism of action for RLA-23174, a small molecule allosteric HIPK2 inhibitor,  involves disrupting the interaction between HIPK2 and Smad3, thereby reducing TGF-β signalling without completely blocking HIPK2 or TGF-β receptor systems.

This selective inhibition is expected to minimise serious adverse effects while exerting anti-fibrotic effects.

The asset demonstrated to possess superior anti-fibrotic effects, substantial in vivo activity, robust pharmacokinetic properties in animal models, and a favourable safety profile in preclinical studies.

It is also claimed to have promising druggability and development potential.

Rila Therapeutics CEO Robert Drakas said: “Dosing of the first cohort in this first human study with RLA-23174 is a meaningful milestone for Rila Therapeutics.

“It signifies our evolution into a clinical development company bringing us closer to helping patients with kidney disease.”

The company develops first-in-class medicines for fibrotic disease treatment and its programmes target key molecular pathways.