InnoCare Announces End-of-Phase 2 Meeting with FDA and Agreement to Initiate a Phase III clinical trial of orelabrutinib for the treatment of PPMS
Beijing, Sept. 8, 2024——InnoCare Pharma (HKEX: 09969; SSE:688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the Company has successfully held an End of Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical development of orelabrutinib for the treatment of multiple sclerosis (MS). InnoCare has reached an agreement with the U.S. FDA on the initiation of a Phase III trial of orelabrutinib in patients with Primary Progressive Multiple Sclerosis (PPMS).
The U.S. FDA also encouraged the Company to initiate a second phase III clinical trial of orelabrutinib in PMS (Progressive Multiple Sclerosis) in the Secondary Progressive Multiple Sclerosis (SPMS) patients.
Orelabrutinib is a BTK inhibitor with high target selectivity and high brain-penetration to achieve high target occupancy in the central nervous system.
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 immune-neuropathology of MS. BTK inhibitors have the potential to transform the treatment paradigm of autoimmune diseases including MS.
Conference Call Information
InnoCare will host a conference call at 10:30 a.m. Beijing time on September 9 in Chinese and at 8:30 p.m. U.S. eastern time in English on September 9, 2024. Participants must register in advance of the conference call. Details are as follows:
For English conference call, please register through the below link:
https://ubs-innocare-pharma-sept.open-exchange.net/
For Chinese conference call, please register through the below link:
About Multiple Sclerosis (MS)
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 today[1]. 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 2030[2]. The majority of MS patients are initially diagnosed with RRMS, most of which will eventually transition to secondary progressive multiple sclerosis (SPMS). About 15% of MS patients are diagnosed with primary progressive multiple sclerosis (PPMS) featured by steadily worsening symptoms but typically without relapses or periods of remission. There is a lack of highly effective therapies for PMS, largely attributable to the challenges for the intervention to act in the central nervous system and to target the immuno-neuropathological process of PMS, therefore, highly unmet medical needs exist.
About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and autoimmune diseases. 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 profiles.
On Dec. 25, 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into the National Reimbursement Drug list, allowing it to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.
In addition, orelabrutinib is being advanced in autoimmune diseases trials worldwide, including: a phase III registrational trial for the treatment of primary immune thrombocytopenia purpura (ITP) in China, a global phase II study for the treatment of Multiple Sclerosis (MS), a phase IIb study for the treatment of SLE in China that has achieved proof of concept (PoC), and a phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) ongoing in China.
About InnoCare
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.
Forward-looking Statement
This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.
[1] Source:MSIF websitehttps://www.msif.org/about-ms/what-is-ms/
[2] Source: Frost & Sullivan Analysis
