BXCL501 was well tolerated with no serious or severe adverse events across the entire dose range.BXCL501 adaptive Phase 1b trial in agitated Alzheimer’s disease/dementia patients is expected to begin in Q4 2019. It is a randomized, double-blind, placebo-controlled, multiple ascending dose study assessing efficacy, pharmacokinetics, safety and tolerability of BXCL501 dosing in adult (18-65 years old) males and females with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Medicines and Healthcare products Regulatory Agency (MHRA) for the double combination trial of BXCL701 and Keytruda® in tNEPC patients. BioXcel Therapeutics has announced plans to initiate two Phase III clinical trials of BXCL501 for the acute treatment of agitation in schizophrenia and bipolar disorder patients. Recent consensus guidelines emphasize the need for non-coercive management strategies to protect the therapeutic alliance between patients and their healthcare providers—an alliance that is critical for the effective management of chronic psychiatric conditions. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.For signing up for our whitepaperZUMEDU, created by SWIL Systems, provides cloud-based, end-to-end encrypted video conference solutions for clinical researchers, including contract research organisations (CROs), sponsors and institutions.ZUMEDU, created by SWIL Systems, provides cloud-based, end-to-end encrypted video conference solutions for clinical researchers, including contract research organisations (CROs), sponsors and institutions.You can withdraw your marketing consent at any time by submitting an opt-out request. Results from secondary analyses showed statistically significant calming as measured by the ACES (Agitation-Calmness Evaluation Scale) at two hours compared to placebo following a single dose of 80 mcg (p=0.0156), 120 mcg (P=0.0005) and 180 mcg (P<0.0001). ET
We also anticipate results from the company’s Phase 1b clinical trial of BXCL501 for agitation in Alzheimer’s and dementia in the first half of 2020. Any such forward-looking statements represent management’s estimates as of the date of this press release. The Phase 1 pharmacokinetic (bioavailability) and safety study of BXCL501 yielded positive top-line data in 28 healthy volunteers.The FDA authorized the IND application for the triple combination of BXCL701, bempegaldesleukin (produced by Nektar Therapeutics, Inc., or Nektar) and BAVENCIO® (avelumab, Merck KGaA, Darmstadt, Germany and Pfizer) in pancreatic cancer.