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Trial completion date, Trial primary completion date: A PET Study Following a Single Oral Dose of ITI-333 in Healthy Subjects (clinicaltrials.gov) - Jan 11, 2023
P1, N=24, Recruiting,
Currently, this investigational new drug is in phase I clinical development. Trial completion date: Dec 2022 --> Aug 2023 | Trial primary completion date: Dec 2022 --> Aug 2023
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Mechanism of Action of ITI-333, a Novel Modulator of Mu Opioid, Serotonin, and Dopamine and for the Treatment of Opioid Use Disorder (Grand Sonoran F) - Oct 31, 2022 - Abstract #ACNP2022ACNP_476;
Results Cell-based assays demonstrate ITI-333 is a biased MOP receptor partial agonist, acting as an antagonist to block effects of high doses of morphine in pain and motor activity models; acting alone as an analgesic in acute and inflammatory pain models...ITI-333 (0.3, 1, and 3mg/kg, SC) dose-dependently suppresses signs of opioid withdrawal precipitated by naloxone injection in oxycodone-dependent mice (i.e., oxycodone dosed for 8 days; increasing daily doses of 9-33 mg/kg, n=10/group)...ITI-333 was safe and well-tolerated in a first-in-human safety study and continues in clinical development as a treatment for OUD. Conclusions Data support a role for ITI-333 in mitigating opioid withdrawal symptoms with no significant indications of abuse liability.
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Clinical Research on Novel Pharmacologic and Immunologic Approaches to Treating Cannabis Use Disorder and Opioid Use Disorder (Grand Sonoran F) - Oct 31, 2022 - Abstract #ACNP2022ACNP_172;
Haney will present Phase 1-2a studies testing the pregnenolone analogue, AEF0117, a signaling specific inhibitor of the cannabinoid type 1 receptor...D’Souza, will describe findings from a near-completed multi-site Phase 2b trial testing the effects of PF-04457845, an orally active, longacting, potent, and selective inhibitor of fatty acid amide hydrolase (FAAH), the primary enzyme degrading the endocannabinoid, anandamide...Comer will present the safety, immunogenicity, and preliminary efficacy data from a Phase 1a/1b study to evaluate an opioid vaccine targeting oxycodone in non-treatment-seeking participants with OUD, as well as preclinical data that were used to support the clinical research. Snyder will present unpublished data describing the preclinical pharmacological profile of ITI-333 in animal models of opioid withdrawal and craving and the clinical translation of ITI-333 into Phase I SAD study.
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ITI-333: An Investigational Drug for the Treatment of Opioid Use Disorder (Grand Ballroom 1) - Oct 17, 2019 - Abstract #ACNP2019ACNP_559;
New data include, but are not limited to, results in neuropathic pain models in rodents and nonhuman primate self administration. New plans for clinical development of ITI-333 will also be discussed.
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Responses to the Opioid Epidemic: Government, Industry and Academic Perspectives (Grand Ballroom 1) - Oct 17, 2019 - Abstract #ACNP2019ACNP_555;
As an example of industry response to the opioid crisis, Kimberly Vanover, PhD (SVP, Early Stage Clinical Development and Translational Medicine, Intra-Cellular Therapies), will describe updated results for compound, ITI-333, is a serotonin 5-HT2A antagonist, a biased partial mu opioid agonist, and has affinity for dopamine D1 receptors...For the treatment of opioid overdose, NIDA is supporting the development of a nasal spray containing nalmefene, a longer acting alternative to naloxone...From an academic perspective, Laura Bohn, PhD, will discuss development of novel mu opioid receptor biased agonists. Unique Data Unique data from NIDA, NINDS, industry and academic sources will be presented.
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