Latest news with #schizophrenia
Yahoo
10 hours ago
- Business
- Yahoo
EuMentis Therapeutics Receives U.S. FDA Clearance of IND Application for EM-221, a Novel PDE10A Inhibitor for Schizophrenia
-Company expects to initiate Phase 2 study in 2H 2025- SAN DIEGO, July 30, 2025 /PRNewswire/ -- EuMentis Therapeutics, Inc., ("EuMentis"), a clinical-stage drug development company focused on advancing novel treatments for schizophrenia and other central nervous system (CNS) conditions, today announced that the U.S. Food and Drug Administration (FDA) has authorized its Investigational New Drug (IND) application to initiate a Phase 2 clinical trial of EM–221, the company's investigational phosphodiesterase 10A (PDE10A) inhibitor, in patients with schizophrenia. "This IND clearance represents a major milestone for EuMentis as we advance EM–221 through Phase 2 clinical development," said Frank Stonebanks, Chief Executive Officer of EuMentis. "EM–221 is more than a single asset—it represents a pipeline in a product with potential applications across multiple neuropsychiatric and neurodevelopmental conditions. As we enter this next phase, we're excited by the opportunity to unlock significant therapeutic and commercial value in schizophrenia and beyond, supported by a world-class team and leading scientific collaborators." EM-221 is targeting PDE10A, a key intracellular enzyme that regulates dopamine and glutamate signaling in brain regions implicated in schizophrenia. Unlike traditional antipsychotics that broadly block dopamine receptors and are associated with serious side effects such as weight gain, movement disorders, and sedation, PDE10A inhibition offers a more targeted mechanism that modulates these pathways without direct receptor antagonism. "We are very excited to receive IND clearance from the FDA for schizophrenia, which is a serious, lifelong disorder affecting nearly 4 million adults and adolescents in the U.S. alone," said Dr. Randall Marshall, Chief Medical Officer of EuMentis. "There is a wealth of data suggesting that a PDE10A inhibitor can benefit individuals with schizophrenia as a more effective, safer, and better-tolerated therapy. We look forward to initiating our Phase 2 study of EM-221 later this year." EM–221 is a next-generation, selective PDE10A inhibitor designed to maximize efficacy while minimizing off-target effects. Preclinical and phase 1 clinical studies suggest EM–221 may offer superior tolerability and a broader therapeutic window, positioning it as a potential best-in-class treatment for both the positive and negative symptoms of schizophrenia—a critical gap left unaddressed by current therapies. "Despite decades of use, current dopamine receptor-blocking antipsychotic medications remain limited in their tolerability and effectiveness which make them unacceptable to many patients," said Dr. John Krystal, Robert L. McNeil, Jr. Professor of Translational Research and Chair of Psychiatry at Yale School of Medicine. "The PDE10A mechanism represents an important and innovative approach to modulating dopaminergic and glutamatergic signaling in the brain. I'm encouraged by the potential of EM–221 to offer a new therapeutic option for patients who urgently need safer and more effective treatments." About EM-221 EuMentis is building a pipeline-in-a-product around EM-221. EM-221 is an innovative product that targets the phosphodiesterase 10A enzyme, uniquely concentrated in the brain's striatum, to enhance cyclic nucleotide signaling and balance dopamine pathways. Unlike traditional antipsychotics, it offers the potential to address not only the positive symptoms like hallucinations but also the challenging negative symptoms—such as social withdrawal, blunted emotions and difficulty planning—that often persist untreated. EM-221 has been cleared by the U.S. FDA for Phase 2 evaluation, and the company expects to begin dosing in its first clinical trial in the second half of 2025. About EuMentis Therapeutics EuMentis is a clinical-stage drug development company focused on advancing novel treatments for schizophrenia and other central nervous system (CNS) conditions. EuMentis is committed to leading innovation in the neuropsychiatric disease field by advancing programs that target selective CNS circuits in the brain with clinically validated mechanisms of action. This approach will enable its therapies to achieve better efficacy and tolerability, with the goal to deliver improved outcomes for patients. The Company's lead product, EM-221, is a potentially groundbreaking advancement in schizophrenia treatment, with a new, differentiated PDE10A inhibitor. Developed through years of rigorous research, this breakthrough heralds a new era of hope, aiming to improve overall quality of life for those affected by schizophrenia with a novel mechanism that's both precise and promising. EuMentis is headquartered in San Diego, CA. For more information, please visit and engage with us on LinkedIn. Media ContactAmy ConradJuniper Pointamy@ Company ContactFrank StonebanksCEOfstonebanks@ View original content to download multimedia: SOURCE EuMentis Therapeutics, Inc. Sign in to access your portfolio
The Independent
2 days ago
- Health
- The Independent
The role llamas might play in treating schizophrenia
Llamas – likely without red pajamas – may hold the key to treating schizophrenia. The serious brain disorder causes people to interpret reality abnormally, and affects approximately 3.7 million U.S. adults between the ages of 18 to 65 years old, according to the nonprofit RTI International. But the domesticated South American woolly animal might be be able to help. French researchers said this week that they had used llama antibodies, or proteins that help to protect the immune system, to design a tiny fragment of an antibody known as a 'nanobody' that will trigger a neurotransmitter in the brain involved in regulating neural activity. Neurotransmitters are chemical molecules that carry messages or signals from one nerve cell to the next target cell, according to the Cleveland Clinic. No llamas were harmed in the study and researchers can identify nanobodies in a petri dish. In the past, llama antibodies have also proven effective in fighting Covid and other 'SARS-like' viruses. When scientists at the Institute of Functional Genomics injected the molecule into the veins or the muscles, it was able to break the blood-brain barrier and effectively reach brain receptors. The barrier is a a tightly locked layer of cells that defend your brain from harmful substances. Studying the impact of the nanobodies in two tests using mice, the researchers found that they corrected cognitive deficits that were observed. There was an improvement of cognitive function with just one shot, and a prolonged effect over one week. Clinical studies are now required to show that their findings could be a new avenue of treatment for schizophrenia. "In humans obviously we don't know [yet], but in mice yes, it is sufficient to treat most deficits of schizophrenia," molecular biologist Jean-Philippe Pin told Newsweek.. He was a co-author of the research which was published in the journal Nature. Pin said that medications currently given to schizophrenia patients "treat the symptoms well, but less the cognitive deficits." The cause of the chronic condition remains unknown, but the World Health Organization says it is thought that an interaction between genes and a range of environmental factors may be the reason. The exact prevalence of schizophrenia is difficult to measure. Some have tied cases in Canada to cannabis use. Although schizophrenia can occur at any age, people are typically diagnosed between the ages of 16 and 30. Symptoms vary from person to person. There is no cure, but it can be treated through antipsychotic medications, talk therapy, and self-management strategies, the National Alliance on Mental Illness says. The study's authors hope to add this strategy to the list. 'This research confirms the potential of nanobodies as a new therapeutic strategy for acting on the brain, with their use eventually being broadened to include the treatment of other neurological illnesses,' the institute said in a statement.
The Independent
2 days ago
- Health
- The Independent
How llamas could change the way we treat schizophrenia
French researchers have developed a potential new treatment for schizophrenia using llama antibodies. They engineered tiny antibody fragments, known as nanobodies, which can cross the blood-brain barrier to target specific brain receptors. In tests on mice, these nanobodies successfully corrected cognitive deficits observed in models of schizophrenia. A single injection demonstrated improved cognitive function, with effects lasting for over a week. The findings suggest a promising new therapeutic approach for schizophrenia and potentially other neurological conditions, pending human clinical trials.
Yahoo
2 days ago
- Business
- Yahoo
ATAI Life Sciences (ATAI) Stock Plunge on Trial Failure News
July 28 - Atai Life Sciences (NASDAQ:ATAI) shares slid 9% in pre?market trading on Monday after Recognify Life Sciences, an Atai?backed company, reported its Phase 2b trial of inidascamine for cognitive impairment linked to schizophrenia missed its primary endpoint. Warning! GuruFocus has detected 6 Warning Signs with ATAI. The oral compound, engineered to modulate multiple neurotransmitter pathways for pro?cognitive effects, failed to outperform placebo on key cognitive measures. Recognify said the results fell short of statistical significance. Atai's CEO acknowledged the setback but highlighted inidascamine's potential in CIAS and other indications. He added that Atai will redirect its efforts toward its wholly?owned psychedelic programs focused on affective disorders. Investors have been closely watching Atai's broader pipeline, which includes compounds targeting depression, PTSD and Alzheimer's disease. This latest trial disappointment adds to a string of mid?stage readouts that have tested market sentiment around biotech firms pivoting to next?generation neuroscience therapies. Despite today's drop, Atai's management reiterated its commitment to advancing its lead psychedelic candidates through upcoming Phase 1 and Phase 2 trials. Based on the one year price targets offered by 6 analysts, the average target price for ATAI Life Sciences NV is $9.83 with a high estimate of $12.00 and a low estimate of $7.00. The average target implies a upside of +175.44% from the current price of $3.57. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
The Independent
3 days ago
- Health
- The Independent
This fuzzy animal friend may be the key to treating schizophrenia
Llamas – likely without red pajamas – may hold the key to treating schizophrenia. The serious brain disorder causes people to interpret reality abnormally, and affects approximately 3.7 million U.S. adults between the ages of 18 to 65 years old, according to the nonprofit RTI International. But the domesticated South American woolly animal might be be able to help. French researchers said this week that they had used llama antibodies, or proteins that help to protect the immune system, to design a tiny fragment of an antibody known as a 'nanobody' that will trigger a neurotransmitter in the brain involved in regulating neural activity. Neurotransmitters are chemical molecules that carry messages or signals from one nerve cell to the next target cell, according to the Cleveland Clinic. No llamas were harmed in the study and researchers can identify nanobodies in a petri dish. In the past, llama antibodies have also proven effective in fighting Covid and other 'SARS-like' viruses. When scientists at the Institute of Functional Genomics injected the molecule into the veins or the muscles, it was able to break the blood-brain barrier and effectively reach brain receptors. The barrier is a a tightly locked layer of cells that defend your brain from harmful substances. Studying the impact of the nanobodies in two tests using mice, the researchers found that they corrected cognitive deficits that were observed. There was an improvement of cognitive function with just one shot, and a prolonged effect over one week. Clinical studies are now required to show that their findings could be a new avenue of treatment for schizophrenia. "In humans obviously we don't know [yet], but in mice yes, it is sufficient to treat most deficits of schizophrenia," molecular biologist Jean-Philippe Pin told Newsweek.. He was a co-author of the research which was published in the journal Nature. Pin said that medications currently given to schizophrenia patients "treat the symptoms well, but less the cognitive deficits." The cause of the chronic condition remains unknown, but the World Health Organization says it is thought that an interaction between genes and a range of environmental factors may be the reason. The exact prevalence of schizophrenia is difficult to measure. Some have tied cases in Canada to cannabis use. Although schizophrenia can occur at any age, people are typically diagnosed between the ages of 16 and 30. Symptoms vary from person to person. There is no cure, but it can be treated through antipsychotic medications, talk therapy, and self-management strategies, the National Alliance on Mental Illness says. The study's authors hope to add this strategy to the list. 'This research confirms the potential of nanobodies as a new therapeutic strategy for acting on the brain, with their use eventually being broadened to include the treatment of other neurological illnesses,' the institute said in a statement.
