Biscayne Neurotherapeutics, created by Biscayne Pharmaceuticals to develop drug therapies to treat neurological diseases like epilepsy, has closed on $3 million in financing to advance a novel antiepileptic compound into a Phase 1b clinical trial.
Clinical studies of the new extended-release form of the compound, BIS-001, will evaluate it for the treatment of adults with epilepsy who have refractory complex partial seizures.
“Patients with severe epilepsies urgently need more effective therapies with fewer disabling side effects,” Stephen Collins, MD, PhD, Biscayne Neurotherapeutics’ president and CEO, said in a press release. “BIS-001 has demonstrated exceptional anti-seizure activity preclinically and an encouraging safety profile in a Phase 1a trial.”
Collins said the company is thrilled that new and existing investors provided the financing for the Phase 1b trial to assess the new extended release form of BIS-001. The trial is scheduled to start by the middle of 2017.
“If all goes well, we expect to initiate a Phase 2a trial in 2018 and to pursue an accelerated clinical program in a number of hard-to-treat epilepsies,” he added.
Biscayne Neurotherapeutics is a spin-out of Biscayne Pharmaceuticals, based in Miami. The $3 million Series B financing will primarily be used to conduct the Phase 1B trial.
BIS-001 is a highly potent form of huperzine A, a synthetic extract of a traditional Chinese medicine that’s been used safely for years. The compound is an acetylcholinesterase (AChE) inhibitor with high brain penetration that offers a unique mechanism of action to treat epilepsy.
In research findings published in Frontiers in Pharmacology, huperzine A showed promising results in eliminating seizures in most mouse models used, with no safety issues.
Biscayne’s extended formulation of the compound is designed to enhance tolerability and ensure patients of its convenience in the treatment of refractory forms of epilepsy, including Dravet syndrome.
“In addition to its powerful anti-seizure 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,” said Steven Schachter, MD, a neurology professor at Harvard Medical School and a scientific co-founder of Biscayne.
“Our clinical program will assess both anti-seizure efficacy and whether BIS-001 supports improved cognition in epilepsy patients,” Schachter said. “At a minimum, we are optimistic it will be devoid of the detrimental effects on cognition seen with many existing antiepileptic drugs.”
He said the company is “eager to test BIS-001 in a variety of conditions, given the high unmet therapeutic need that exists across the spectrum of seizure disorders.”