Biscayne Pharmaceuticals has spun out a new company, Biscayne Neurotherapeutics, with $3 million in Series B funding, to continue clinical devleopment with its acetylcholinesterase (AChE) inhibitor antiepileptic candidate BIS-001. The funding will support a Phase Ib trial evaluating an extended-release formulation of BIS-001 in adult patients with refractory complex partial seizures. BIS-001 is a synthetic form of huperzine A, which was originally extracted from a traditional Chinese medicine, and which Biscayne claims exhibits high levels of brain penetration. The Series B fundraising was led by the Global Health Sciences Fund of Quark Venture, GF Securities, and Mesa Verde Venture. New and existing investors in Biscayne Pharmaceuticals also participated.

Miami, FL-based Biscayne Neurotherapeutics is initially developing BIS-001 to treat refractory forms of focal epilepsy, including the childhood seizure disorder Dravet syndrome. The extended-release formulation of BIS-001 is designed to improve tolerability and patient compliance across different dose ranges.

Biscayne Neurotherapeutics CEO, Stephen Collins, M.D., Ph.D., said, “Patients with severe epilepsies urgently need more effective therapies with fewer disabling side effects. BIS-001 has demonstrated exceptional antiseizure activity preclinically and an encouraging safety profile in a Phase Ia trial. We are delighted that our new and existing investors have provided the financing to advance our new extended-release formulation of BIS-001 into a Phase Ib clinical trial that is scheduled to begin by mid-year. If all goes well, we expect to initiate a Phase IIa trial in 2018 and to pursue an accelerated clinical program in a number of hard-to-treat epilepsies.”

Steven Schachter, M.D., professor of neurology at Harvard Medical School and a scientific co-founder of Biscayne, added, “In addition to its powerful antiseizure activity in preclinical models of severe epilepsy, BIS-001 has exhibited the cognition-enhancing properties seen with other AChE drugs, but with much better central nervous system and systemic tolerability and safety than currently available agents. Our clinical program will assess both antiseizure efficacy and whether BIS-001 supports improved cognition in epilepsy patients. At a minimum, we are optimistic it will be devoid of the detrimental effects on cognition seen with many existing antiepileptic drugs.”

Biscayne Therapeutics is separately leveraging its growth hormone-releasing hormone (GHRH) platform for the devleopment of GHRH antagonist against cancer and GHRH agonists for the potential treatment of cardiac damage resulting from cardiovascular disorders.