Clinical-stage biotechnology company Graviton BioScience Corporation announced on Wednesday the publication of peer-reviewed data from a multicentre Phase Ib/II multi-dose, open-label clinical trial evaluating the safety, tolerability, and efficacy of GV101 (TDI01) in patients with moderate to severe chronic Graft versus Host Disease (cGvHD).

The data, published in Signal Transduction and Targeted Therapy, a Springer Nature Portfolio journal, provide efficacy and findings from the 60 enrolled patients, 30 at 200mg and 30 at 400mg, who had previously received one to five prior systemic therapies for cGvHD.

GV101, a novel, highly selective ROCK2 inhibitor, yielded an 86.2% best overall response rate (bORR) at 400 mg and a 67.9% bORR at 200 mg at 24 weeks in cGvHD patients who had failed at least two prior lines of therapy. GV101's 24-week bORR exceeds published six-month bORRs for all existing, approved steroid-refractory cGvHD therapies, Graviton said.

Failure-free survival (FFS) was 83.9% at 24 weeks and reached 89.4% at 400 mg (78.6% at 200 mg). This FFS also exceeds published six-month FFS probabilities for all approved steroid-refractory cGvHD therapies.

GV101 is a clinical-stage, best-in-class selective inhibitor of Rho/Rho-associated coiled-coil containing protein kinase 2 (ROCK2). ROCK2 is a key regulator of multiple cellular pathways involved in inflammation, fibrosis, metabolism, and gene expression. GV101 has been evaluated in preclinical and clinical studies and is being developed for multiple potential indications.