Editor’s note: WRAL TechWire and the Council for Entrepreneurial development are partnering to present a series of profiles and Q&As featuring companies startups and emerging companies participating in the CED’s annual Life Science conference coming up Feb. 28-March 1 in Raleigh. The latest profile is BetaBlue, which is based in Graham, N.C. and targets schizophrenia.

BetaBlue

  • Web site:​ http://www.beta-blue.com
  • CEO: Jeremy Ollerenshaw,
  • Contact information: ford@beta-blue.com
  • Sub-sector: Biotech and Pharmaceutical                                                                    
  • Headquarters: Graham, NC                                                          
  • Year Founded: 2016

COMPANY PROFILE

BetaBlue is an early stage biopharmaceutical company seeking to commercialize functionally selective ligands for the D2 dopamine receptor with the goal of improved efficacy in treating the negative and cognitive symptoms of schizophrenia. We are also pursing development for additional indications, including bipolar disorder, depression, levodopa-induced dyskinesia, childhood dystonia, and addiction disorders.

FOUNDERS/MANAGEMENT TEAM

  • Jeremy Ollerenshaw PhD, Chief Executive Officer
  • Jeremy Ford MD MBA, Chief Innovation Officer
  • Stephen Montgomery PhD, Chief Development Officer

KEY MILESTONES TO DATE

  • Company Founded by Jeremy Ford and Jeremy Ollerenshaw, June 2016
  • Option for Co-Exclusive License obtained from UNC-Chapel Hill, August 2016
  • Preparation of STTR and Michael J. Fox Foundation Grant Applications, September-November 2016
  • Recruitment of Stephen Montgomery, PhD, who has overseen the submission of multiple IND applications and previously worked for the FDA, November 2016

Q&A

  • What is the primary pain point you are seeking to address?

Schizophrenia is a mental disorder characterized by positive symptoms (delusions, hallucination), negative symptoms (blunted affect, lack of motivation, social problems), and cognitive symptoms (disorganized thinking, impaired learning). Positive symptoms come from too much dopamine in a part of the brain called the striatum, and the negative and cognitive symptoms arise from too little dopamine in the brain’s cortex.

Drugs, known as dopamine blockers, or antagonists, have been available since the 1950s to treat the positive symptoms but have been ineffective in treating the cognitive and negative symptoms. Dopamine antagonists, which also block dopamine signaling in the cortex, in fact make these symptoms worse.

The voices may stop, but the emotional and cognitive issues remain. Therefore, despite being on drug therapy, many people living with schizophrenia continue to have shorter life expectancies, require significant community services, and fail to reach their full potential.

  • What sets your company apart? What’s the “secret sauce”?

The challenge lies in developing a drug to serve simultaneously as a dopamine activator and blocker depending on which region in the brain the drug acts. Until now, that was largely considered fool’s errand. By exploiting a cell signaling feature known as functional selectivity, our lead compound activates dopamine receptors in the cortex while blocking dopamine in the striatum, creating the pharmacologic foundation for the first drug to concurrently treat all three symptom domains of schizophrenia.

Our family of compounds has been tested in animal models of psychosis, cognition, and sociability, with great success. What’s more, our lead compound is based on the structure of one of the bestselling drugs of all time, so low toxicity is expected in preclinical studies and clinical trials.

  • Why should investors be interested in your company? What is the potential market size?

“Me too” antipsychotics, with weak claims to novelty and superiority, still perform very well, largely because true innovation in this space has been lacking. These include Latuda, which achieved $1.3 billion in sales in 2015, and newly released Rexulti, which is pegged to reach peak sales of $1.4 billion.

These examples suggest that psychiatrists, patients, and payors have low price sensitivity, even if a new antipsychotic demonstrates minimal advantages over generic competitors. In other words, the bar for a minimum differentiable product is low in the antipsychotic space. The pipeline has also run dry, as Big Pharma has divested from antipsychotic development after multiple high profile drug failures. Of note, these failed drugs were attempting to exploit non-dopamine mechanisms of action for negative and cognitive symptoms.

The time is ripe for a truly antipsychotic that actually works. Once our lead clears preclinical studies, clinical trials, and FDA approval, peak annual revenues could easily exceed $1-2B.