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Biscayne’s BIS-001ER bound for China
MIAMI—Biscayne Neurotherapeutics, Inc., announced a licensing agreement today with Global Drug Development Centre China (GDCC), registered as China Global Bio-Pharmaceutical Industry Development (Chengdu) Co., Ltd. The license covers rights to Biscayne’s lead antiepileptic product BIS-001ER in China, Taiwan, Hong Kong and Macau.
The agreement gives GDCC rights to BIS-001ER’s intellectual property in these territories, and Biscayne will provide technical assistance to GDCC to facilitate the development, regulatory approval and marketing of the product. Biscayne Neurotherapeutics received an upfront payment from GDCC and is also eligible to receive milestone payments and royalties on BIS-001ER sales. Financial details were not disclosed.
“We are delighted to finalize an agreement for the development and marketing of BIS-001ER in China, the world's largest market for antiepileptics. The agreement is an example of the multiple benefits we are realizing from our relationship with Quark Ventures and the Global Health Sciences Fund, which led our 2017 Series B financing,” said Stephen Collins, MD, PhD, President and Chief Executive Officer of Biscayne Neurotherapeutics. “They were instrumental in facilitating this partnership with GDCC, their drug development and marketing affiliate in China.
“Notably, BIS-001ER is a highly potent form of huperzine A, a synthetic extract of a traditional Chinese medicine with a long history of safe use in neurological disorders. We look forward to the opportunity to provide technical assistance to our colleagues at GDCC as they develop and market this promising new agent with the potential to help the many epilepsy patients poorly served by current treatments,” Collins continued.
Huperzine A is an acetylcholinesterase inhibitor with high brain penetration that offers a unique mechanism of action for the treatment of epilepsy. It has shown promising efficacy in highly predictive preclinical models of refractory epilepsy. Biscayne’s extended release formulation is designed to enhance tolerability across a range of doses, and ensure patient convenience and medication adherence. In a Phase 1b study, BIS-001ER achieved its goal of twice-daily dosing and exhibited serum drug exposure levels that were almost twice as high as the levels researchers think are needed to achieve strong efficacy results. Adverse events were generally mild to moderate, transient and non-dose limiting.
Jesson Chen, Chairman of Global Drug Development Centre China (GDCC), commented, “Its promising efficacy and safety profile and roots in traditional Chinese medicine make BIS-001ER a potentially valuable new therapy for the Chinese epilepsy market. Our researchers are eager to initiate a clinical program in China, and we expect that Biscayne will provide us with valuable assistance as we move to advance our development activities for BIS-001ER.”
Biscayne has also separately commenced a Phase 2 study of BIS-001ER in subjects with Focal (onset) Impaired Awareness Seizures (FIAS), the most common form of adult epilepsy. BIS-001ER is a novel agent that has shown promising results in preclinical models of severe epilepsy and successfully completed a Phase 1b safety trial late last year.
The Phase 2 proof of concept trial will assess the ability of BIS-001ER to reduce seizures in subjects with FIAS, previously known as Complex Partial Seizures. FIAS affects an estimated 35% of adults with epilepsy. FIAS seizures that are not responsive to treatment cause serious, life-altering problems for patients and can be fatal. While some patients achieve good control with current treatments, there is substantial unmet need for more therapeutic options. The Phase 2 study is being conducted at two internationally-recognized epilepsy centers of excellence in Australia using a well-validated robust design that includes advanced video EEG techniques. Results are expected later this year.
Biscayne is developing BIS-001ER to treat refractory forms of focal epilepsy, including FIAS and catastrophic pediatric onset epilepsies such as Dravet and Lennox Gastaut syndromes. It has been awarded a U.S. FDA Orphan Drug designation for the treatment of Dravet syndrome.