Ketamine Hydrochloride

BEDFORD, Mass.--( BUSINESS WIRE )--Delix Therapeutics, a clinical-stage neuroscience company pioneering novel neuroplasticity-promoting treatments for psychiatric and neurological disorders, today announced that the first patient has been dosed in its Phase 1b clinical trial to evaluate the pharmacodynamics (PD), safety, tolerability, and pharmacokinetics (PK) of DLX-001, a novel non-hallucinogenic neuroplastogen, in Major Depressive Disorder (MDD). “Building on promising preclinical studies that demonstrate DLX-001’s ability to rapidly promote robust structural and functional neuroplasticity within hours, as well as sustained therapeutic effects in animal models of depression, the initiation of this trial represents a pivotal milestone in the development of novel treatments for patients suffering from MDD,” said Aaron Koenig MD, Chief Medical Officer of Delix Therapeutics. “Importantly, data from our Phase 1 first-in-human study demonstrated that DLX-001 achieves therapeutic exposures with predictable PK, a favorable safety and tolerability profile, and no evidence of psychotomimetic, dissociative, or hallucinogenic effects. We are excited to progress this novel first-in-class agent and gain insights that will strengthen the design of our upcoming Phase 2 study in MDD.” The Phase 1b study will evaluate the PD, safety, tolerability, and PK of DLX-001 in approximately 20 patients with MDD. Based on the results of the completed single and multiple ascending dose (SAD-MAD) study in healthy volunteers, patients will receive daily oral DLX-001 over seven days at doses that produced statistically significant changes in quantitative electroencephalography (qEEG) in healthy volunteers. The key objective of the Phase 1b study is to assess effects on translational biomarkers following DLX-001 administration, including qEEG, polysomnography, and other exploratory markers. Preliminary efficacy will also be assessed. Delix is rapidly advancing its library of novel, non-hallucinogenic compounds into scalable, orally bioavailable therapies. The Company’s compounds have demonstrated the ability to promote fast-acting and long-lasting repair of synapses associated with neuropsychiatric and neurodegenerative conditions, without the liabilities inherent to first- and second-generation plasticity-promoting compounds such as LSD, ketamine, psilocybin, and MDMA. About DLX-001 DLX-001 is a novel, non-hallucinogenic, non-dissociative isotryptamine neuroplastogen currently being evaluated for the treatment of Major Depressive Disorder (MDD). Preclinical data has demonstrated that DLX-001 increases dendritic spine density in PFC neurons and has rapid and enduring antidepressant-like effects in animal models after a single dose. Recent Phase 1 data has demonstrated that DLX-001 is associated with robust signs of CNS engagement and a favorable safety and tolerability profile, with no serious adverse events reported to date. About Neuroplastogens Neuroplastogens are a novel class of potentially disease-modifying therapeutics for psychiatric and neurological conditions. These compounds promote rapid and sustained neuroplasticity in select neural circuits resulting in fast-acting therapeutic effects. Neuroplastogens are novel chemical entities inspired by compounds that are proving to be beneficial across a range of neuropsychiatric and neurodegenerative disorders, in addition to other synaptopathies. Leveraging our phenotypic drug discovery engine, Delix is committed to developing a pipeline of cutting-edge neuroplastogens that will target offering faster and more effective therapies addressing the underlying pathophysiology of many neuropsychiatric and neurological diseases. About Major Depressive Disorder (MDD) Major Depressive Disorder (MDD) is a prevalent and debilitating condition affecting over 280 million people globally, 1 with 21 million people suffering in the United States alone. 2 MDD represents the primary cause of disability in the world, 3 and is typically characterized by persistent feelings of sadness and loss of interest. Even with available approaches, many patients do not experience an optimal response to treatment, resulting in a significant need for new and differentiated treatments. 4 About Delix Therapeutics Delix Therapeutics is a clinical-stage neuroscience company focused on harnessing the power of novel neuroplasticity-promoting therapeutics to better treat patients struggling with difficult-to-treat neuropsychiatric and neurological disorders. The company's compounds are easily manufactured small molecules capable of rapidly inducing structural and functional neural changes in targeted areas of the brain. Through its novel Neuroplastogen Platform, Delix is pioneering a new class of fast-acting outpatient pharmacotherapies and rapidly advancing through preclinical and clinical development to bring patients FDA-approved, take-home medicines that will serve several unmet needs and enhance the psychiatric treatment paradigm for patients and providers. References: World Health Organization. Depressive disorder (depression). World Health Organization. Published March 31, 2023. https://www.who.int/news-room/fact-sheets/detail/depression . National Institute of Mental Health. Major Depression. National Institute of Mental Health. Published July 2023. https://www.nimh.nih.gov/health/statistics/major-depression . National Library of Medicine. Major Depressive Disorder. National Institute of Mental Health. Published April 10, 2023. https://www.ncbi.nlm.nih.gov/books/NBK559078/ . Rush, A. J., et al. Am J Psychiatry , (2006).

INDIANAPOLIS--( BUSINESS WIRE )-- Gate Neurosciences , a synaptic health biotechnology company focused on advancing next-generation precision central nervous system (CNS) treatments, today announced the initiation of a Phase 2 clinical study with the University of Pittsburgh (Pitt) to assess the potential for extending the efficacy of apimostinel – a rapid-acting antidepressant drug candidate that enhances synaptic plasticity – in combination with Pitt’s digital therapeutic. The Phase 2 study ( Clinicaltrials.gov ID: NCT06400121 ) led by Dr. Rebecca Price Ph.D., the university’s associate professor of psychiatry, psychology and clinical and translational science, will assess the utility of combining Pitt’s Automated Self-Association Training (ASAT) tool in extending the duration of apimostinel’s single-dose antidepressant effects. ASAT is a digital neurocognitive training program that uses cognitive tasks to condition patients to associate thoughts about themselves with positive attributes. The combination of neurocognitive training in the presence of apimostinel is hypothesized to leverage a “primed window of brain plasticity” as a more targeted and efficient method to extend relief in depressed patients. “Our precision drug candidates work by rapidly enhancing synaptic function and neuroplasticity, which has broad potential across mental health and cognitive disorders,” said Mike McCully, president and CEO of Gate Neurosciences. “This Phase 2 study partnership with Pitt gives us an exciting opportunity to potentially extend apimostinel’s treatment benefit in depressed patients with the ASAT platform, a synergistic and innovative digital tool.” Dr. Price has previously conducted a similar randomized clinical trial ( 1 , 2 , 3 ) with the rapid antidepressant drug ketamine, plus ASAT training, in patients with treatment-resistant depression. Dr. Price found that one 40-minute ketamine infusion combined with four days of ASAT exercises had statistically significant extended effects on depression that endured for three months, whereas a typical efficacy response from a single ketamine infusion lasts for up to seven days. Gate’s drug candidates apimostinel and zelquistinel share ketamine’s convergent downstream mechanism of enhancing neuroplasticity via the NMDA receptor; however, both of Gate’s molecules have exhibited a superior safety profile versus ketamine with evidence of reduced dissociative or psychotomimetic side effects. “We are thrilled to partner with Gate to further explore ASAT’s efficacy with apimostinel and build on our previous success with extending ketamine’s benefit for depressed patients,” said Dr. Price. “ASAT was crafted to complement rapid-acting treatments for psychiatric disorders. It is designed to be as efficient as possible with short digital administrations and shows promise for extending single-dose outcomes by months.” Apimostinel is a second-generation, intravenous NMDA receptor PAM (positive allosteric modulator) being developed by Gate Neurosciences for acute psychiatric disorders. In a prior single-dose Phase 2 study, apimostinel demonstrated rapid and statistically significant 24-hour antidepressant effects that lasted up to seven days and was well-tolerated. Most recently, Gate’s Phase 1 biomarker study of apimostinel showed positive dose-dependent qEEG biomarkers of NMDAR target activation. About Gate Neurosciences Gate Neurosciences is a synaptic health biotechnology company focused on advancing next-generation precision CNS treatments that address growing needs in mental health. The company is developing a portfolio of novel mechanisms of action that enhance synaptic function to address neuropsychiatric and neurocognitive diseases, including major depressive disorder (MDD). Using learnings from extensive clinical, preclinical, and translational data and a better understanding of CNS development challenges, the company is advancing its clinical pipeline using evidence-driven, precision psychiatry approaches.