InnoCare Pharma is preparing to launch a Phase 2 trial to assess the safety and efficacy of orelabrutinib, its investigational Bruton tyrosine kinase inhibitor, in patients with relapsing-remitting multiple sclerosis (RRMS).
The trial, which is expected to enroll approximately 160 patients, will be carried out in the U.S. and several European countries. The announcement came after the company learned the U.S. Food and Drug Administration (FDA) cleared its request — in the form of an investigational new drug (IND) application — to advance orelabrutinib into MS clinical testing.
“I am very delighted to learn the swift IND clearance by the US FDA, and we are initiating the phase II clinical trial immediately,” Jasmine Cui, PhD, co-founder, chair, and CEO of InnoCare, said in a press release.
Orelabrutinib is a potent, selective, oral inhibitor of the enzyme Bruton tyrosine kinase (BTK), which plays a key role in the survival and activity of immune B-cells. This subset of antibody-producing immune cells can give rise to different types of blood cancers when they become malignant, and are also thought to be one of the key drivers of inflammation in MS.
Thus, by blocking the activity of BTK, orelabrutinib is thought to limit the survival and growth of malignant B-cells, and lower inflammation throughout the body. For this reason, the therapy is currently being investigated as a potential treatment for B-cell lymphomas and autoimmune diseases across a range of clinical studies ongoing in the U.S. and China.
According to the company, preliminary studies have shown that orelabrutinib can block BTK’s activity by more than 90%, without interfering with the function of other enzymes. Additionally, the therapy has shown a favorable pharmacological profile so far, which allows it to be given once daily at a low dose without compromising its ability to specifically and strongly inhibit BTK activity.
Orelabrutinib has also shown a favorable safety and robust efficacy profile, and was found to be able to cross the blood-brain barrier — the semi-permeable membrane that separates the brain from the rest of the blood circulating in the body — and reach the brain.
“Orelabrutinib has demonstrated sustained anti-inflammatory activity and safety profile, plus our recent finding that orelabrutinib does have a good level of [blood-brain barrier] penetration capability, so we believe our decision to move into MS studies is prudent and promising,” Cui said.
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