Mont-Saint-Guibert, Belgium, 10 May 2024: Cellaïon, a clinical stage biotech, announces the discontinuation of the company’s Phase 2b clinical trial ‘DHELIVER’ with HepaStem®, an allogenic cell therapy, under development for life-threatening liver diseases.

The decision is based on the results of an interim review of global data presented to the independent Data Safety Monitoring Board (DSMB), of the data from 129 patients randomised to the trial, the study being fully recruited, and all patients having received treatment. The global data demonstrated that the trial would show no difference in  survival, versus placebo, at 90 days for Acute on Chronic Liver Failure (ACLF) patients on HepaStem® (the study primary endpoint). The decision is not based on safety or tolerability findings. 

Dr (Med) James Neil Phillips, CEO, said, ‘Our team is grateful to the patients, families and healthcare professionals involved in the DHELIVER trial. The results are not what we hoped for, but success rates for therapies in Phase 2 trials are less than 50% overall. Our research and work have potentially contributed to advancing our understanding to help people living with life-threatening liver diseases.’

The company will work closely with the Health Authorities and the clinical trials sites to implement the discontinuation of the trial. Taking into account these results, the company and its Board of Directors believe that there is no use in any further development of HepaStem®. As HepaStem® is the company’s single asset for the treatment of ACLF, the company will be entering into a period of consultation with its employees, in line with Belgian employment law, in relation to its intention to close operations. The company will ensure the correct consultation process is followed and provide the required support to employees.

The annual shareholder meeting (ASM) scheduled for 10 May 2024 is cancelled as the agenda and reports did not consider the trial results, which were unblinded after the mailing of convening notices. An ASM and an Extraordinary Shareholder Meeting will be scheduled in due course.