July 28, 2017 9:49 AM ET


Company Overview of Biscayne Pharmaceuticals, Inc.

Company Overview

Biscayne Pharmaceuticals, Inc., a clinical stage biotechnology company, develops drugs for difficult-to-treat conditions in central nervous system (CNS) disorders. It develops drugs to treat refractory epilepsy and drug-resistant cancer. The company develops new therapies for CNS disorders based on a highly potent acetylcholinesterase inhibitor that is used to treat central nervous system ailments; and new cancer therapies based on molecular target–growth hormone-releasing hormone (GHRH) receptors. Its compounds include GHRH antagonists in development for the treatment of cancer; and GHRH agonists for the repair of cardiac damage in animal models of myocardial infarction (heart attack), redu...

4770 Biscayne Boulevard

Suite 660

Miami, FL 33137

United States

Founded in 2012



Key Executives for Biscayne Pharmaceuticals, Inc.

Chief Executive Officer, President and Director
Co-Founder and Executive Chairman
Age: 42
Scientific Co-Founder
Director of Finance & Administration
Compensation as of Fiscal Year 2017.

Biscayne Pharmaceuticals, Inc. Key Developments

Biscayne Pharmaceuticals, Inc. Reports New Scientific Publication

Biscayne Pharmaceuticals, Inc. reported that a new scientific publication shows that BIS-001 can eliminate all seizures in the majority of animals in models of the catastrophic type of epilepsy known as Dravet syndrome. BIS-001 is a clinical-stage, highly potent agent with a novel mechanism of action that is a synthetic form of huperzine A, an extract of a traditional Chinese medicine. Biscayne is initially developing BIS-001 for the treatment of children with Dravet syndrome and for adults with complex partial seizures. Dravet syndrome is a catastrophic, genetically-mediated early life seizure disorder associated with prolonged, recurrent refractory seizures; cognitive and behavioral deficits and a 15–20% mortality rate. The SCN1A sodium channel mutations implicated in Dravet syndrome are also associated with other serious inherited epilepsy conditions that affect both children and adults. Available antiepileptic drugs often fail to protect against the severe seizures and cognitive deficits in these patients, and new treatments are urgently needed. The new studies assessed BIS-001 in mice who have the same SCN1A mutations seen in human Dravet syndrome and are subject to similar severe seizures. The studies were conducted in the Emory University laboratory of Dr. Andrew Escayg. In these studies, BIS-001 completely eliminated seizures in the majority of treated animals at doses expected to be well-tolerated and achievable in patients with a new extended release formulation of BIS-001. Importantly, the effects of BIS-001 were sustained over time, with high levels of anti-seizure activity maintained during repeat dosing for up to 21 days, with no evidence of the tachyphylaxis, or diminishing efficacy, that can be seen with other antiepileptic drugs. BIS-001 appeared to be well-tolerated in these animals. Biscayne expects to advance BIS-001 into a Phase 1b study in adults in mid-2017, and if all goes well, to proceed to a Phase 2 study shortly thereafter. Clinical trials in children will commence after successful completion of FDA-required juvenile animal safety testing.

Biscayne Pharmaceuticals Presents Data On Novel Antiepileptic Agent BIS-001 at EILAT Conference On New Antiepileptic Drugs

Biscayne Pharmaceuticals, Inc. reported that it presented data on lead compound BIS-001 at the Thirteenth Eilat Conference on New Antiepileptic Drugs in Madrid, Spain. BIS-001 is a clinical-stage, highly potent and selective acetylcholinesterase (AChE) inhibitor that is a synthetic form of the traditional Chinese medicine huperzine A. Biscayne is initially developing BIS-001 for the treatment of adults with complex partial seizures (CPS) and children with the devastating condition Dravet syndrome. About 30% of CPS patients are fully refractory to current therapy and there are no approved treatments for Dravet syndrome. It showed high central nervous system (CNS) penetration, with a very high affinity for the antiepileptic site of action and low systemic effects. In contrast to other agents in the class tested by the NIH that were only effective at toxic doses, BIS-001 demonstrated superior efficacy to existing products at doses that appeared well-tolerated. BIS-001 is also far more potent than marketed antiepileptic drugs--it was 57 times more potent than the standard of care therapy levetiracetam (Keppra®) and completely eliminated seizures in a mouse model of Dravet's. Dr. Collins also presented pharmacokinetic data from a Phase 1a study of the original oral immediate release formulation of BIS-001. The data showed that the immediate release formulation would have required frequent dosing and that it produced high peak serum levels associated with non-serious, but annoying side effects. Biscayne is currently developing novel extended release formulations of BIS-001 with improved pharmacokinetic profiles that will reduce dosing frequency. Dr. Collins discussed preliminary data on the prototype extended release formulations, which exhibit improved pharmacokinetics with gradual, controlled release rates that support twice-daily dosing regimens. Further studies of the new formulations are underway, and the company expects to initiate a Phase 1b trial with one of the new formulations in 2016.

Biscayne Pharmaceuticals, Inc. Announces Executive Changes

Biscayne Pharmaceuticals, Inc. announced that it has merged with Insero Health. Stephen Collins, MD, PhD, formerly Chief Executive Officer of Insero Health, has become President and CEO of Biscayne Pharmaceuticals. Samuel Reich, who co-founded both Biscayne and Insero Health, will retain the position of Executive Chairman of the combined companies.

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