Update on the ABC008(Ulviprubart) IBM Clinical Program

We would like to share an important update from Abcuro regarding the ABC008 (Ulviprubart) clinical development program in Inclusion Body Myositis (IBM) after a conversation with their medical affairs head.

Following the announcement earlier this year that the Phase 2/3 ABC008-IBM-201 study did not meet its primary or key secondary endpoints, Abcuro has now informed the community that it will be closing the ABC008-IBM-202 Open-Label Long-Term Extension (LTE) study.

As a result, participants currently receiving ulviprubart through the extension study will be transitioned off treatment and will no longer have access to the investigational therapy at this time.

According to Abcuro, study sites and investigators have been notified and will communicate directly with participating patients regarding next steps.

The company indicated that this decision was made after careful consideration as it evaluates future options for both the IBM program and the company. Abcuro also stated that it hopes a pathway may be available in the future that could allow former study participants to restart therapy if deemed appropriate by patients and their healthcare providers, although no such mechanism can currently be guaranteed.

We recognize that this news may be disappointing for patients, care partners, investigators, and everyone who has invested time and hope in this program. We especially want to acknowledge the contribution of the IBM community members who participated in these studies. Clinical trial participation remains essential to advancing our understanding of IBM and developing future treatments. 

MSU continues to support new initiatives around the world to understand and treat IBM with our translational medicine program.

As additional information becomes available, we will continue to keep the community informed.