Business
Ensysce Biosciences Provides Business Update and Reports First Quarter 2022 Financial Results
Corporate Update Call to be Held Tuesday, May 17, 2022SAN DIEGO, CA / ACCESSWIRE / May 12, 2022 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company")
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"Corporate Update Call to be Held Tuesday, May 17, 2022SAN DIEGO, CA / ACCESSWIRE / May 12, 2022 / Ensysce Biosciences, Inc. (\"Ensysce\" or the \"Company\") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance focused on reducing abuse and overdose, today reported financial results for the first quarter 2022.Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, \"The first few months of 2022 are off to an exciting start, evident in the most recent clinical results from trials PF614-102 and PF614-MPAR-101. As we progress on our studies and clinical trials, we are closer to realizing our mission - providing abuse and overdose protection where needed. I look forward to our upcoming corporate update call next week to discuss the recent results from the trials, especially regarding the longer-lasting profile of PF614 and the encouraging initial data from our overdose protection study. Additionally, we expect the Bioequivalence (BE) trial data of our TAAP™ opioid, PF614, to be available prior to the end of the second quarter, positioning PF614 as our first commercial candidate and demonstrating progress towards our goal to bring a unique pipeline of products to the market.\"TAAPTM (Opioid Abuse Deterrent Program) UpdatesOn May 5, 2022, the Company announced clinical trial results from trial PF614-102 confirming the safety and longer-lasting profile of PF614 versus Oxycontin.The results of the study show the longer-lasting half-life of PF614 versus OxyContin as seen in the prior Phase 1 single-ascending dose study of PF614 oral solution versus OxyContin. We believe this data confirms the findings from our Phase 1 study that demonstrate PF614 should provide true twice-daily dosing.The safety data for the study also showed that PF614 performed similarly to OxyContin with no serious treatment emergent adverse events recorded.The second part of the PF614-102 study, the bioequivalence (BE) arm, continues to be analyzed and as reported previously, we anticipate that this BE data will be available by the end of the second quarter of 2022. The Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval.Human abuse liability (HAL) studies to determ...