We assessed the potential of over 7,000 possible combinations of muscarinic receptor agonists and antagonists to find an optimized combination that could preferentially stimulate muscarinic receptors in the CNS to improve the symptoms of psychosis, while avoiding stimulation of muscarinic receptors in the peripheral tissues and the associated side effects. In the trial, 91% of KarXT treated patients escalated to the increased dose which was similar to the escalation rate with placebo.
M1 and M4 muscarinic receptors are the receptor subtypes believed to mediate the antipsychotic, procognitive and analgesic effects of xanomeline and other muscarinic agonists. The M1/M4 preferring agonist xanomeline is analgesic in rodent models of chronic inflammatory and neuropathic pain via central site of action. 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. American Journal of Psychiatry 2008; 165:1033–1039. 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. PureTech engaged with a group of leading schizophrenia experts who were most excited about muscarinic agonists, pointing to the data generated by Eli Lilly with xanomeline, which was not advanced at that time due to tolerability issues.
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.
That's not to take anything away from Karuna's recent results; They're excellent. Karuna Therapeutics CEO Dr. Steve Paul says the biotech firm is hopeful its new therapy for schizophrenia will prove effective for patients in further clinical trials. Patients were washed-out of antipsychotic medicines and randomized 1:1 to receive either KarXT or placebo for five weeks. 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. Approximately 40 percent of the estimated 8.4 million patients with dementia in the United States are diagnosed with the disease, with around 1.2 million experiencing symptoms of psychosis. 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. There are approximately 2.7 million adults living with schizophrenia and approximately 8.4 million people living with dementia in the United States. Muscarinic receptor subtypes mediating central and peripheral antinociception studied with muscarinic receptor knockout mice: a review. The number of discontinuations due to treatment emergent AEs were equal in the KarXT and placebo arms (n=2 in each group).
“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. This combination has the potential to be a new option for treating the difficult symptoms of debilitating CNS disorders, such as schizophrenia, without subjecting patients to the problematic side effects associated with current antipsychotic standard of care therapies.
Fresh off a meeting with the FDA, Karuna Therapeutics (NASDAQ:KRTX) will advance lead candidate KarXT into Phase 3 development for the treatment of … The point is that even with a successful stage 2 trial, there's still plenty of risk for Karuna's KarXT at this stage. Psychosis is a prominent and debilitating symptom that occurs in many neuropsychiatric disorders, including schizophrenia, dementia, bipolar disorder, major depressive disorder and inflammatory neurological diseases, such as multiple sclerosis, but there are no existing medicines that sufficiently and safely treat psychosis and cognition impairments. 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. However, investors should ask themselves whether a 700% surge in stock price -- based on just one set of phase 2 results -- is justified in the grand scheme of things.
There are currently no approved treatments for dementia-related psychosis.
The tolerability of KarXT was also reflected in the trial’s high rate of dose escalation. We want to hear from you. Analysts at Goldman Sachs, Wells Fargo, and Wedbush all issued buy ratings for the stock earlier this year. 1997 May;281(2):868-75. International Journal of Neuropsychopharmacology 2011; 14:1233–1246.
Cumulative Growth of a $10,000 Investment in Stock Advisor, Why Investors Should Resist Buying Karuna Therapeutics, Even Though It's Surging @themotleyfool #stocks $KRTX $PFE $RHHBY $AZN, The Coronavirus Pandemic Will Delay 2020 IPOs. Effects of Xanomeline, a Selective Muscarinic Receptor Agonist, on Cognitive Function and Behavioral Symptoms in Alzheimer Disease.
Results from preclinical studies and clinical trials conducted by third parties support the hypothesis that xanomeline can reduce psychosis and improve cognition. It's pretty common for a biotech stock to jump 20%, 30%, 50%, or more on strong news, such as receiving U.S. Food and Drug Administration (FDA) approval for a breakthrough drug. Founded by PureTech, Karuna is developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders, including schizophrenia and dementia-related psychosis. Karuna Therapeutics soars on potentially 'game changing' new schizophrenia drug. Karuna plans to initiate a Phase 3 EMERGENT program evaluating KarXT for the treatment of adults with schizophrenia by the end of 2020.
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.
To PureTech’s knowledge, xanomeline is the only muscarinic agonist that has demonstrated potential therapeutic benefit in humans in either schizophrenia or AD. The study enrolled 182 schizophrenia patients with acute psychosis, 90 of whom received KarXT. You can change your choices at any time by visiting Your Privacy Controls. This trial evaluated twice-a-day dosing of the proprietary KarXT co-formulation containing fixed ratios of xanomeline and trospium, rather than the three-times-a-day dosing previously used with xanomeline. "We're cautiously optimistic given the robustness of the clinical data that we reported this week.".
forward into future studies in patients with dementia-related psychosis. After the live webcast, the event will remain archived on the Karuna Therapeutics website for three months.
For more information, please visit karunatx.com.
A statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed (p<0.001).
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