Reviva Pharmaceuticals CEO Tells Benzinga About The Trouble With Today's Schizophrenia Drugs – And How The Company Is Fixing That

Schizophrenia afflicts about 24 million people around the globe, yet when it comes to treating it, the world still needs to rely on centuries-old treatments. Reviva Pharmaceuticals Holdings Inc. (NASDAQ:RVPH), a late clinical stage pharmaceutical company, is aiming to change that with Brilaroxazine, its schizophrenia drug in development. Reviva CEO Laxminarayan Bhat recently sat down with Benzinga to discuss the state of the schizophrenia treatment market, how Brilaroxazine is aiming to transform it and what the market opportunity is for the company.

Brilaroxazine is a once-daily, serotonin-dopamine signaling modulator with the potential to reduce neuroinflammation. It works by modulating the activity of serotonin and dopamine receptors in the brain, acting as a partial agonist and antagonist, with the goal of stabilizing the serotonin/dopamine system involved in schizophrenia and other neuropsychiatric disorders.

Already Proving Its Mettle 

The drug has already successfully completed a phase 3 study and a one-year open-label extension (OLE) trial, as well as clinical pharmacology studies. All of the studies have demonstrated positive results for the treatment of schizophrenia, including statistically significant reductions in major symptoms and a well-tolerated safety profile, reported the company. The reductions in symptoms were across symptoms, from hallucinations and delusions to lack of motivation, decreased ability to experience pleasure and low social drive. 

The company reports that the trials also demonstrated strong and sustained efficacy from acute to maintenance treatment after one year, with a large number of patients showing reductions in their Positive and Negative Syndrome Scale (PANSS) scores. 

According to Bhat, the problem with schizophrenia is that symptoms usually come on in the early teenage years and typically stay with a person throughout their adult life, which means they need lifelong medication. Developing ones that work over the long haul has proven difficult.

 "It has to be durable and safe enough to take life long," Bhat told Benzinga. "Only fourteen drugs have gotten approved over the last forty years." As a result, around one-third of the 24 million people with schizophrenia do not respond to the current treatments either fully or partially, said Bhat. "This is a huge unmet need."  How big? Bhat said the schizophrenia market opportunity is $12 billion and that the wider anti-psychotic market opportunity is close to $40 billion. 

Targeting Schizophrenia At Its Root 

According to the CEO, what makes Brilaroxazine unique is that it targets neuroinflammation, which is present in every person who suffers from schizophrenia and bipolar or major depressive disorder. By targeting neuroinflammation, Bhat said the drug can enhance and sustain efficacy and also address side effects, which can include weight gain. Brilaroxazine proved to have anti-inflammatory effects in two clinical trials, noted Bhat.  

While Reviva is focused on treating schizophrenia with its drug candidate, Bhat said it also has potential for other diseases of the brain, including bipolar and major depression. All three are caused by a dysfunction in serotonin-dopamine neurochemicals, but at different levels. "An antipsychotic drug that has a good safety profile is also approved beyond schizophrenia to bipolar and major depression disorder at different dose levels," said Bhat, noting Brilaroxazine falls into that category. "That's why (we call it) a pipeline in a drug." Combined, Bhat said the bipolar and major depression disorder market opportunity is $23 billion. 

As for recent M&A activity in the schizophrenia drug market, including Bristol-Myers Squibb’s (NYSE:BMY) acquisition of  Karuna Therapeutics Inc. and Johnson & Johnson’s (NYSE:JNJ) purchase of Intra-Cellular Therapies, Bhat says Reviva isn't deterred. Many of those deals are around add-on treatments, not a new approach like what Brilaroxazine brings. "It doesn't matter. The proof is in the pudding, and we believe we have good pudding," said Bhat. "We have good safety and good efficacy. I believe physicians will notice that when it comes to the market and patients will benefit." 

Featured image from Shutterstock.

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