Acticor Enrolls First Patient in Phase 2/3 Stroke Treatment Study

After demonstrating positive results in a Phase 1b/2a study, Acticor Biotech’s glenzocimab is moving forward in the clinic with the first patient enrolled in a Phase 2/3 trial evaluating the safety and efficacy of the drug in patients with acute ischemic stroke.

Beginning the Pivotal Clinical Trial

France-based Acticor is bringing glenzocimab into its newest Phase 2/3 clinical trial called ACTISAVE, with the intention of enrolling 1,000 participants worldwide to study the drug’s safety and efficacy in treating acute ischemic stroke. The trial will study glenzocimab in combination with standard-of-care therapies like thrombolysis with the recombinant tissue plasminogen activator and thrombectomy. 

Acticor is collaborating with approximately 80 specialty healthcare centers in the US, Europe, Great Britain, and Israel to administer glenzocimab in patients with acute ischemic stroke. The company will undergo a first futility analysis with the first 200 enrolled patients to confirm the initial hypothesis. 

Glenzocimab is a humanized monoclonal antibody fragment (fab) designed to target the human platelet glycoprotein GPVI. Acticor designed the drug to decrease symptomatic and asymptomatic intracerebral hemorrhage (sICH) events in patients with acute ischemic stroke. 

During the Phase 1b/2a clinical trial, ACTIMIS, Acticor reported that the drug did reduce sICH events in the study. Additionally, across the 166 participants with a median age of 75, participants in the glenzocimab group experienced an 8% death rate, with a 19% death rate in the placebo group. 

Chief Operating Officer and Chief Medical Officer at Acticor, Dr. Yannick Pletan, said, “The opening of the first U.S. centers, in addition to those already active in Europe, marks another important milestone for our ACTISAVE Phase 2/3 study. The cumulative incidence of ischemic stroke in the USA, Europe, Japan, and China will approach 4 million patients by 2026, highlighting the urgent need for an effective treatment to address this major public health problem with a strong societal and economic impact.”

Related Article: Bristol Myers Squibb’s New Drug Boasts Strong Anti-thrombotic Profile

Glenzocimab’s Regulatory Success So Far

Going into the ACTISAVE trial, glenzocimab has achieved a few regulatory milestones, marking signs of early success for the drug. In July, the European Medicines Agency granted the drug Priority Medicines status, recognizing glenzocimab’s potential clinical benefit in treating acute ischemic stroke. 

In November 2021, Acticor received notice that the FDA accepted glenzocimab’s Investigational New Drug application. Unfortunately, the drug was not eligible for Breakthrough Therapy status based on the Phase 1b/2a secondary endpoints. Still, Acticor says it plans to apply for Fast Track status in the coming weeks based on the new Phase 2/3 clinical trial criteria. 

The first enrolled patient in its newest Phase 2/3 clinical trial is exciting news for Acticor because it marks the company’s first late-stage clinical trial for its leading candidate. With any luck, glenzocimab will keep moving forward, providing benefits to patients with acute ischemic stroke in the clinic before eventually making it to market. 

Author

Reed Slater