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news.US-based biopharmaceutical firm AbGenomics has initiated a Phase-Ib/IIa clinical trial of neihulizumab (AbGn-168H), a humanized monoclonal antibody, for the treatment of steroid refractory acute graft-versus-host disease (aGvHD).
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The investigator-initiated trial is sponsored by Stanford University and its primary objective is to evaluate the safety and efficacy of AbGn-168H in patients with steroid refractory aGvHD in the post-allogeneic transplantation setting.
aGVHD is a complication of hematopoietic cell transplantation (HCT) that accounts for most non-relapse mortality and limits the use of HCT.
Before initiating the aGvHD trial, the proof of clinical efficacy and safety of AbGn-168H has been well shown in a randomized, multicenter, double-blind, placebo-controlled Phase II trial in patients with moderate-to-severe plaque psoriasis.
Recently, the company has also started an open-label, multi-center Phase II trial for psoriatic arthritis.
Steroid refractory aGVHD carries an especially high mortality of between 60-85% and according to reports, a huge unmet medical need of aGvHD needs to be satisfied under the existing therapies.