China-based Benethera has received investigational new drug (IND) approval in the US to commence a first-in-human clinical trial for BT-101, its first-in-class oral drug candidate designed to induce regulatory T-cells (Tregs) in vivo for the treatment of inflammatory bowel disease (IBD). The Phase I study will evaluate the safety, tolerability and pharmacokinetics of BT-101 in healthy adult volunteers through single and multiple ascending dose cohorts. This milestone marks the clinical-stage entry for the company, which was founded in December 2021.

BT-101 is a small molecule that works by targeting a specific G protein-coupled receptor (GPCR) to promote the differentiation of endogenous naive T-cells into functional Tregs within the intestinal immune system. This mechanism, leveraging oral immune tolerance, aims to restore immune balance in IBD patients without the broad immunosuppression associated with some existing therapies. The company's pipeline also includes other Treg-focused assets for autoimmune and inflammatory conditions.

PharmCube's NextBiopharm® database shows that Benethera's pipeline additionally includes four preclinical assets in several immunology indications. Click here to request a free trial for NextBiopharm®.