This morning clinical-stage biopharmaceutical company Karuna Therapeutics Inc. (KRTX:NASDAQ), which focuses on developing novel therapies for people with disabling and potentially fatal neuropsychiatric disorders and pain, announced results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia.
According to the company, "KarXT is an oral coformulation of xanomeline (a novel muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist) designed to treat psychosis and related symptoms through preferential stimulation of muscarinic receptors in the central nervous system (CNS)."
The firm noted that in the Phase 2 trial, KarXT demonstrated statistically significant and clinically meaningful improvement in total PANSS score at all time points over five weeks and was well-tolerated compared to placebo. The firm further stated that the data from the study supports advancing KarXT to Phase 3 and continued development in other CNS disorders.
Jeffrey Lieberman, M.D., professor and chairman of the Department of Psychiatry, Columbia University, College of Physicians and Surgeons and a member of Karuna's scientific advisory board, commented, "The results of the Phase 2 trial are impressive and encouraging because they indicate that KarXT, if approved, could represent a game-changing therapeutic advance in the treatment of patients with schizophrenia...The effectiveness of antipsychotics has been limited by the frequent and serious side effects of first- and second-generation drugs which are difficult for many patients to tolerate, are potentially harmful, and lead to high rates of discontinuation and relapse. In addition to its novel mechanism of action, KarXT could be a new therapeutic option that has the potential to offer robust efficacy devoid of weight gain, metabolic effects and extrapyramidal side effects."
Steve Paul, M.D., CEO, president, and chairman of Karuna, added, "The schizophrenia treatment landscape has remained rather stagnant for decades with therapeutic options relying on discoveries dating back to the 1950s...KarXT and its novel muscarinic receptor mechanism of action represent the potential to become a true advancement in how schizophrenia is treated, allowing patients relief from their debilitating psychotic symptoms without experiencing some of the very troubling side effects associated with current treatments."
The company's Chief Medical Officer Stephen Brannan, M.D., stated, "We are extremely pleased with these results, as the 11.6-point PANSS score separation from placebo far exceeded the five-point minimum improvement that has historically supported approval of current antipsychotics...With this information, and following our anticipated end-of-Phase 2 meeting with the FDA in the second quarter of 2020, we will work to initiate a Phase 3 clinical trial of KarXT in patients with schizophrenia by the end of 2020."
The company elaborated in the report that the KarXT study was a Phase 2, randomized, double-blind, placebo-controlled, inpatient trial enrolled 182 adult patients, age 18 to 60, who had been diagnosed with DSM-5 schizophrenia and were experiencing acute psychosis.
The firm explained that "schizophrenia is a chronic, disabling disorder typically diagnosed in late teenage years or early adulthood. Characterized by recurring episodes of psychosis requiring long-term treatment with antipsychotic drugs in most patients, it affects more than 21 million people worldwide and 2.7 million Americans."
Karuna Therapeutics is headquartered in Boston, Mass., and is a clinical-stage biopharmaceutical company focused on developing and delivering first-in-class therapies for people with central nervous system (CNS) disorders. CNS disorders remain among some of the most disabling and potentially fatal disorders worldwide. The firm states that "galvanized by the understanding that today's neuropsychiatric and pain management patients deserve better, the company's mission is to harness the untapped potential of the brain's complex biology in pursuit of novel therapeutic pathways that will advance the standard of care". The firm's lead product candidate is KarXT, an oral modulator of muscarinic receptors that are located both in the CNS and various peripheral tissues. It is initially developing KarXT, for the treatment of acute psychosis in patients with schizophrenia.
Karuna started off the day with a market cap of approximately $413.9 million with about 23.41 million shares outstanding. The company completed its initial public offering (IPO) of its shares less than six months ago on July 2, 2019. KRTX shares opened nearly 84% higher today at $32.50 (+$14.82, +83.82%) over Friday's $17.68 closing price. Since the open, the stock has soared much higher hitting a new 52-week high price of $86.00/share. The shares have traded today on high volume between $32.47 and $86.00 per share and are currently trading at $85.00 (+67.32, +380.77%).
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