Innovation Combating Schizophrenia

About 1% of people in the world and over 50% of the US homeless population suffer from schizophrenia, a severe mental illness characterized by delusions and hallucinations (auditory and visual). So, without a doubt treating schizophrenia more effectively has a key role to play in preventing homelessness. One might ask, what are companies (particularly pharmaceutical companies) doing to combat schizophrenia today?

Well, despite the seemingly large market opportunity that treating schizophrenia presents (with over 3 million Americans diagnosed), few companies are developing medications to fight this mental illness. The reason why lies in economic incentives and in one of the key difficulties in treating schizophrenia; many of those who suffer from schizophrenia do not take their medication. In fact, as many as 50% of people who have schizophrenia may have anosognosia, a brain illness that makes them believe they are not ill. Why raise hundreds of millions of dollars to go through the FDA approval process and go-to-market, when your customers are unlikely to buy and even more unlikely to use your medication?

Here are some companies that are taking the risk anyway:

Karuna Pharmaceuticals is developing one of the only new antipsychotic drugs in the last few decades. Their medication, called KarXT (xanomeline combined with trospium chloride), was originally developed in the 1990’s by another company called Lilly, for Alzheimer’s to improve memory (then only consisting of xanomeline). It was found to be far more effective at treating psychosis, a common symptom of Alzheimer’s. Unfortunately, xanomeline caused terrible gastrointestinal side effects and the medication was shelved by Lilly. In 2009, Karuna was founded on the premise that xanomeline, combined with another medication specialized in treating overactive bladders (tropsium chloride), may be the answer to improving treatment for schizophrenia. KarXT addresses schizophrenia in a way that previous medications have not, targeting “muscarinic receptors” rather than blocking dopamine and serotonin receptors in the brain as other antipsychotic drugs like Zyprexa, Seroquel, and Abilify do. Karuna announced in late 2019 the success of their stage 2 clinical trials on 180 patients with schizophrenia, stating that KarXT demonstrated a statistically significant and clinically meaningful reduction in the total Positive and Negative Syndrome Scale (PANSS) score compared to placebo (and relatively few side effects). Karuna has raised over $211 million to date and IPOed (NAS: KRTX).

Lyndra Therapeutics, a company that specializes in long-acting, oral, sustained-release therapies is attacking the market problem from its source by creating a schizophrenia medication that only needs to be taken once a week, instead of daily. This gives schizophrenia patients the leeway they need; it is far easier to bring oneself to take the medication once a week than once per day. Their medication, called risperidone, is designed to be long-acting as it resides in the stomach longer than typical schizophrenia medication, dispersing active ingredients consistently over time. Lyndra’s Chief Medical Officer (CMO) Dr. Richard Scranton is overseeing Lyndra’s progression through Stage I and II clinical trials as of early 2020. Lyndra has raised over $60 million in venture capital financing, closing their Series B round in early 2019.

Click Therapeutics is developing novel prescription therapeutic treatments that utilize software as a medium for treatment rather than medication (though their treatment may be prescribed concurrently with pharmaceutical drugs). Their therapies undergo a rigorous development process backed by scientific research, must demonstrate effectiveness in (FDA) clinical trials, and must be prescribed by a physician. Click Therapeutics uses the famous “painkiller vs. vitamin” VC analogy to describe the difference between their mobile app and other health apps. Unlike Lyndra and Karuna, Click Therapeutics addresses a wide range of illnesses, with their flagship product called Clickotine targeted at nicotine users who want to quit. Their schizophrenia treatment, codenamed CT-155, is in Click Therapeutics’ first stage of development: Research. Other product offerings in development include treatments for Major Depressive Disorder, Insomnia, Acute Coronary Heart Syndrome, Migraine, Overactive Bladder, Chronic Lower Back Pain, and Obesity. Click’s treatments are also covered by most insurance plans, according to the company’s website. Click Therapeutics has raised over $322 million to date and shows promise to continue growing at a high rate.

While the process of creating any pharmaceutical drug or treatment is fraught with risk, it is even riskier to create a drug/treatment that treats schizophrenia. However, the outlook seems promising that these companies will be handsomely rewarded once they get FDA approval. As Karuna Pharmaceuticals CEO Dr. Steve Paul said, “Big pharma, with some exceptions, has really abandoned psychiatric drugs despite the fact that there’s still huge unmet medical need, despite the fact that there’s incredible commercial value.”