October 24, 2016 6:11 PM 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: 41
Scientific Co-Founder
Director of Finance & Administration
Compensation as of Fiscal Year 2016.

Biscayne Pharmaceuticals, Inc. Key Developments

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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