American Journal of Psychiatry 2008; 165:1033–1039. Why Did Karuna Therapeutics Pop 26% in January? In comparison, Karuna's schizophrenia drug, KarXT, seems to have less severe adverse effects on patients while demonstrating a significant reduction in psychosis symptoms compared to the placebo.
The World Health Organization ranks psychosis as the third-most disabling medical condition in the world. The core team member who was running this program at PureTech became Karuna’s chief operating officer and PureTech built a team of leading drug developers and neuroscientists around him, including Steven Paul, MD, an expert in central nervous system (CNS) drug discovery and development. "We look forward to progressing KarXT into Phase 3 clinical development for the treatment of schizophrenia following a constructive End-of-Phase 2 meeting with the FDA," said Andrew Miller, Ph.D., chief operating officer and founder of Karuna Therapeutics. Despite xanomeline’s promising therapeutic benefit in treating psychosis and related behavioral symptoms in patients with schizophrenia and AD, its potential has been limited by cholinergic side effects, which are believed to result from the stimulation of muscarinic receptors in peripheral tissues. The M1/M4 preferring agonist xanomeline is analgesic in rodent models of chronic inflammatory and neuropathic pain via central site of action. However, even if this is the case, having to redo a phase 3 trial can set a company back for years, further pushing back the release of an otherwise acceptable drug. Tons of companies had encouraging phase 2 trial data only to see diverging results appear in the following phase 3 trial. There is an unmet need for new treatments in schizophrenia that could address the positive, negative and cognitive symptoms and are free of the problematic safety issues with existing medicines.

Karuna anticipates topline results from a Phase 1b clinical trial in healthy elderly volunteers to assess the safety, and tolerability of KarXT early in the second quarter of 2021. Considering that many promising drugs have failed in phase 3 trials, including others targeting schizophrenia, investors need to consider this risk and whether Karuna's lofty valuation is worth it. Following the news that Karuna Therapeutics has announced the Phase III Clinical Trial results of KarXT for acute psychosis in patients with schizophrenia;Alessio Brunello, Senior Pharma Analyst at GlobalData, offers his view: Current antipsychotics are often used by physicians to address a wide range of neuropsychiatric disorders in addition to schizophrenia, including bipolar disorder and psychotic depression, as well as psychosis and agitation in elderly patients with dementia, but are associated with modest efficacy and significant side effects. Additionally, 91% of patients involved in this trial were able to successfully graduate to higher doses of KarXT without having any severe adverse reactions, something which bodes well for the tolerability of the drug.

There are approximately 2.7 million adults living with schizophrenia and approximately 8.4 million people living with dementia in the United States. Karuna Therapeutics soars on potentially 'game changing' new schizophrenia drug. Conference Call and Webcast to Take Place Today at 8:30 … "We have to get this compound through phase three to get it to patients," Paul told "Power Lunch." Karuna plans to initiate a Phase 3 EMERGENT program evaluating KarXT for the treatment of adults with schizophrenia by the end of 2020. Data Support Advancing KarXT to Phase 3 and Continued Development in Other CNS Disorders. © 2020 Karuna Therapeutics. See you at the top! Sign up for free newsletters and get more CNBC delivered to your inbox. “We look forward to progressing KarXT into Phase 3 clinical development for the treatment of schizophrenia following a constructive End-of-Phase 2 meeting with the FDA,” said Andrew Miller, Ph.D., chief operating officer and founder of Karuna Therapeutics. The Company remains on track to initiate the Phase 3 program by the end of 2020. At least half of patients fail to adequately respond to current antipsychotic drugs. Our pipeline is built on the broad therapeutic potential of our lead product candidate, KarXT, an oral modulator of muscarinic receptors that are located both in the central nervous system (CNS) and various peripheral tissues. The tolerability of KarXT was also reflected in the trial’s high rate of dose escalation. KarXT combines xanomeline, a muscarinic receptor agonist that has demonstrated decreases in multiple psychotic symptoms and improvements in cognitive symptoms in placebo-controlled human trials in schizophrenia and alzheimer's disease (AD), and trospium chloride, an FDA approved and well-established muscarinic receptor antagonist that has been shown not to measurably cross the blood-brain barrier. In the clinical trial, patients demonstrated a clinically meaningful and statistically significant 11.6 point mean reduction over placebo in total PANSS score, the trial’s primary efficacy endpoint. Karuna expects to meet with the Food and Drug Administration early next year to "map out the path to get the new medicine to patients," Paul said.

Additionally, the firm said the drug was well tolerated by many of the 182 patients in the trial. Karuna Therapeutics CEO Dr. Steve Paul told CNBC on Friday that the biotech firm is hopeful its new therapy for schizophrenia will prove effective for patients in … This five-week, 1:1 randomized, flexible-dose, double-blind, placebo-controlled, inpatient trial, will enroll approximately 250 adults in the U.S. and evaluate the change in Positive and Negative Syndrome, Scale total score at Week 5 of KarXT versus placebo as the primary outcome measure. The magnitude of the improvement with KarXT compares favorably to meta-analyses of published clinicals trials of currently approved antipsychotic medicines which reported an average difference of nine to ten points in PANSS score versus placebo. The safety and tolerability of KarXT and dose selection for the Phase 2 clinical trial was supported by results from Karuna’s two Phase 1 healthy volunteer studies in over 140 patients with KarXT. Current antipsychotics have modest efficacy in many patients and significant side effects. Galvanized by the understanding that today’s neuropsychiatric and pain management patients deserve better, Karuna’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. BOSTON--(BUSINESS WIRE)--Karuna Therapeutics, Inc. (Nasdaq: KRTX), a clinical-stage biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain, today announced results from its Phase 2 clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia. People with schizophrenia have a ten to fifteen-year reduction in life expectancy compared to the general population, struggle to maintain employment or live independently and are often unable to maintain meaningful interpersonal relationships. M1 and M4 muscarinic receptors are the receptor subtypes believed to mediate the antipsychotic, procognitive and analgesic effects of xanomeline and other muscarinic agonists. been enrolled in the EMERGENT-2 or EMERGENT-3 trials, is expected to commence the first half of 2021. This company, now with a market capitalization of $2.9 billion, has seen its shares skyrocket by over 700% since announcing impressive results for its schizophrenia drug candidate. Karuna's drug tolerability "is a big win," Paul said Friday. Karuna Therapeutics CEO Dr. Steve Paul told CNBC on Friday that the biotech firm is hopeful its new therapy for schizophrenia will prove effective for patients in a late-stage trial. Shares of Karuna soared nearly 400% this week after the Boston-based biotech firm posted positive results Monday for its drug, called KarXT, in a midstage clinical trial. Now, not every phase 3 failure is due to a problem in the drug itself. We also plan to further analyze these results to better understand the potential of KarXT in patients with schizophrenia experiencing negative and cognitive symptoms, and to explore other CNS disorders that could benefit from this approach, such as psychosis in Alzheimer’s disease as well as the management of pain.”. Investors should pay special attention to the very first case study, which featured another promising schizophrenia drug developed by Roche called Bitopertin. That's not to take anything away from Karuna's recent results; They're excellent. Muscarinic receptor subtypes mediating central and peripheral antinociception studied with muscarinic receptor knockout mice: a review.
Tel: 617.482.2333 The problem lies in reaching that point. A live webcast of the conference call will also be available on the investor relations page of the Karuna Therapeutics corporate website at www.karunatx.com. PureTech invented and broadly filed patents to cover the concept of combining a muscarinic receptor agonist with a peripherally acting antagonist, and it in-licensed xanomeline from Eli Lilly in May 2012. In 2017, the FDA published a collection of 22 case studies documenting drugs that had strong phase 2 results yet ended up failing at the phase 3 level. Like all muscarinic receptor agonists studied to date, however, xanomeline’s tolerability has been limited by side effects arising from muscarinic receptor stimulation in peripheral tissues, leading to nausea, vomiting, diarrhea and increased salivation and sweating, collectively referred to as cholinergic AEs (or ChAEs) which led Eli Lilly to discontinue development of xanomeline. Additionally, current treatments are often associated with severe side effects, including sedation, extrapyramidal side effects such as motor rigidity, tremors and slurred speech and significant weight gain resulting in the complications of diabetes, hyperlipidemia, hypertension and cardiovascular disease. Karuna is a clinical-stage biopharmaceutical company committed to developing and delivering first-in-class therapies with the potential to transform the lives of people with CNS disorders – which remain among the most disabling and potentially fatal disorders worldwide. Xanomeline was previously studied by Eli Lilly in randomized, double-blind, placebo-controlled trials in schizophrenia acute psychosis and AD, demonstrating dose-dependent decreases in multiple psychotic symptoms and related behaviors, including hallucinations, delusions and agitation, as compared to patients on placebo in the treatment of psychosis and improvements in symptoms as measured by both the Alzheimer’s disease Assessment Scale-Cognitive Subscale and the Clinician Interview-Based Impression of Change plus caregiver interview standards. Symptoms of the illness include disruptions in thought processes, perceptions and emotional responsiveness. Historically, changes as small as five points have supported the approval of current antipsychotics. Neuroscience. We believe that the above data, as well as our Phase 1 and 2 clinical trials with KarXT demonstrating robust efficacy and significant reductions in the adverse events associated with xanomeline, support the further development of KarXT in multiple neuropsychiatric disorders, including schizophrenia and dementia-related psychosis. The study demonstrated tolerability at xanomeline dose levels exceeding those shown in previous studies of xanomeline alone. A statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed (p<0.001). Patients were washed-out of antipsychotic medicines and randomized 1:1 to receive either KarXT or placebo for five weeks. Karuna addressed this issue by combining xanomeline, a novel muscarinic receptor agonist that preferentially stimulates M1 and M4 muscarinic receptors, with trospium, an approved muscarinic receptor antagonist that does not measurably cross the blood-brain barrier, confining its effects to peripheral tissues. About 3.5 million people in the United States are diagnosed with schizophrenia, and it is one of the leading causes of disability worldwide, according to Schizophrenia and Related Disorders Alliance of America, an advocacy group.


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