InnoCare Announces Clearance by the US FDA of Phase II Clinical Trial Using orelabrutinib for the Treatment of Multiple Sclerosis

BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969), a clinical-stage biopharmaceutical company, announced today the Investigational New Drug (IND) clearance of its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib by the US Food and Drug Administration (FDA) for starting phase II clinical investigations in multiple sclerosis (MS) in the United States.

This will be a randomized, double-blind, placebo-controlled and multi-center phase II Study in Relapsing-Remitting multiple sclerosis patients (RRMS), which will be conducted in the US and several European countries. The trial is expected to enroll 160 patients.

MS is an autoimmune, inflammatory disease of the central nervous system. The immune system destroys myelin surrounding nerves disrupting the normal functioning of the brain, optic nerves, and spinal cord through inflammation and tissue loss. It can cause muscle weakness, fatigue, and visual problems, and ultimately lead to disability. It most often appears when people are between 20 to 40 years old and it is the most common cause of non-traumatic neurological disability in young adults.

According to the Multiple Sclerosis International Federation (MSIF), more than 2.8 million people around the world are affected by MS today¹. According to Frost & Sullivan analysis, global market of MS drugs reached US$23.0 billion in 2018, and it is expected to be up to US$48.9 billion by 2030².

BTK, a key kinase in the B cell receptor signaling pathway, plays important roles in the development and function of B cells, macrophages, and microglia, which are involved in the immunopathological characteristics of MS. BTK inhibitors have the potential to transform the treatment paradigm of autoimmune diseases including MS.

“Orelabrutinib has demonstrated sustained anti-inflammatory activity and safety profile, plus our recent finding that orelabrutinib does have a good level of Brain Blood Barrier (BBB) Penetration capability, so we believe our decision to move into MS studies is prudent and promising. I am very delighted to learn the swift IND clearance by the US FDA, and we are initiating the phase II clinical trial immediately,” said Dr. Jasmine Cui, the co-founder, chairman, and Chief Executive Officer of InnoCare.

Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications. Currently, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies. Current clinical data have demonstrated orelabrutinib’s robust efficacy and safety profile.

About InnoCare Pharma

InnoCare Pharma is a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune disease with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey, and Boston.

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¹ Source:MSIF website https://www.msif.org/about-ms/what-is-ms/
² Source: Frost & Sullivan Analysis