AB Science: €25 Million Insurance to Cover Potential Clinical Trial Failure in ALS
AB Science has received a firm offer for clinical trial financing insurance covering up to €25 million in costs in the event of a failure of its phase III trial AB23005 evaluating masitinib in amyotrophic lateral sclerosis. The company has also voluntarily suspended the recruitment of new patients in Europe to strengthen its organization in response to health authority requirements.
Securing Financial Risk through Insurance
AB Science has secured a firm subscription offer for a Clinical Trial Financing Insurance (CTFI) policy from Medical & Commercial International Ltd., Lloyd's Syndicate 1902, for its phase III clinical trial AB23005. The policy provides coverage with a liability limit of €25 million, which can extend up to €39 million to cover the full financial costs associated with a clinical failure, with no deductible. The placement was organized by Acrisure Re UK, a Lloyd's broker, in collaboration with its European subsidiary Acrisure Re Netherlands. The insurance will take effect from the date the first patient is enrolled, and the premium will be payable at the trial's launch, with the offer being firm until December 31, 2026. This coverage allows AB Science to transfer a significant portion of the financial risk associated with the study's outcomes.
Voluntary Suspension of Patient Recruitment in Europe
AB Science has voluntarily suspended the recruitment of new patients in its studies in Europe during negotiations with the insurer and ongoing discussions with European health authorities. These authorities have raised concerns about the company's resources and its level of organization for conducting clinical studies in Europe. In response, AB Science is reevaluating its strategic priorities. For the launch of the phase III trial on ALS and the continuation of its AB8939 program, AB Science will strengthen its organization to meet the health authorities' requirements. The firm offer of CTFI has contributed to this strategic prioritization, focusing on the phase III trial on ALS where risks have been mitigated. For informational purposes, the AB23005 study will include 408 patients randomized in a 1:1 ratio, evaluating masitinib at a dose of 4.5 mg/kg/day in combination with riluzole compared to riluzole combined with a placebo after 48 weeks of treatment.
