China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced that the US FDA has placed orelabrutinib for use in multiple sclerosis (MS) on partial clinical hold. As a result, new enrollment of the Phase II study in the United States will not be initiated. Participants in the US who have been on orelabrutinib for less than or equal to 70 days will be discontinued, while study participants who have completed more than 70 days in the study will be permitted to continue receiving orelabrutinib.
FDA Action and Safety Measures
The FDA action was based on a limited number of drug-induced liver injury cases observed with orelabrutinib in the ongoing MS Phase II study and other studies in non-MS autoimmune diseases. For all cases, the elevated laboratory values used for monitoring liver injury were reversible following the suspension of orelabrutinib administration. The company will work closely with the FDA to resolve the issues, including the implementation of enhanced safety measures.
Impact on Global Trials and Future Prospects
Enrollment at sites outside of the US will be temporarily put on hold. InnoCare will work with Independent Data Monitoring Committees and health authorities to assess the impact of this partial clinical hold on studies conducted at those sites. The study was reportedly close to completing full enrollment. Orelabrutinib, the third BTK inhibitor to gain approval in China, already has two conditional approvals from China’s National Medical Products Administration (NMPA) for r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL). The drug won clinical trial approval for MS in April 2022.
In July 2021, Biogen (NASDAQ: BIIB) struck a licensing deal with InnoCare, taking exclusive global rights to orelabrutinib for the MS indication and unspecified rights to certain autoimmune diseases in markets outside of Greater China. The deal involved a USD 125 million upfront payment and up to USD 812.5 million in future milestone payouts. A Phase II study in MS for the drug was green-lit in the US in November 2020 and also entered studies in Europe and China.-Fineline Info & Tech
