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Ensysce Biosciences, Inc. (NASDAQ: ENSC) is a San Diego-based clinical-stage biotech company specializing in the development of safer prescription drugs using its proprietary technology platforms. The company focuses on creating new, tamper-proof opioids that aim to reduce drug abuse and prevent overdoses. Ensysce leverages its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms to develop innovative pain relief options with a lower risk of misuse.
The company’s core projects include two key drug platforms: the TAAP technology, which activates upon ingestion to release pain medication, and the MPAR technology, designed to prevent overdose by inhibiting further release of the drug when excess doses are consumed. These platforms are supported by global intellectual property protection, ensuring a wide array of prescription drug compositions.
Recent milestones include the FDA’s Breakthrough Therapy designation for PF614-MPAR, a combination product designed to provide overdose protection alongside effective pain relief. This designation accelerates the drug’s development and review process, highlighting its potential to offer substantial improvements over existing therapies. Ensysce’s lead candidate, PF614, is currently in Phase 3 clinical development, having demonstrated efficacy and safety in previous trials.
In terms of financial health, Ensysce has shown stability, with recent funding from federal grants and warrant exercises supporting ongoing research and development. The company's collaboration with Quotient Sciences aims to further optimize their PF614-MPAR drug product, enhancing its effectiveness and safety profile.
Ensysce is also expanding its product pipeline to address opioid use disorder (OUD) with PF9001, a TAAP-based candidate that has shown promise in reducing cardiovascular side effects compared to traditional treatments. Supported by a multi-year HEAL grant from the NIH and NIDA, this candidate is poised to enter human clinical studies within the next 12 to 18 months.
For more detailed information about Ensysce Biosciences, Inc. and its innovative projects, please visit www.ensysce.com.
Ensysce Biosciences announced positive data from its PF614-102 bioequivalence study, demonstrating that PF614, an abuse-protected opioid, meets FDA standards compared to OxyContin. The study involved 57 healthy volunteers and showed minimal absorption variability under different meal conditions. The findings could facilitate PF614's path to FDA approval via the 505(b)(2) regulatory pathway. Dr. Lynn Kirkpatrick highlighted this as a critical step toward providing a safer pain management alternative. A corporate update call is scheduled for August 17, 2022.
Ensysce Biosciences has initiated the PF614-103 study, testing the abuse potential of PF614 compared to oxycodone in recreational opioid users. This double-blind trial, led by Dr. Glen Apseloff, aims to confirm that PF614 cannot be misused via nasal inhalation. Chief Medical Officer Dr. Nily Osman emphasized the importance of this study in establishing PF614's safety profile, as it requires trypsin activation for efficacy, significantly reducing abuse risk. Results are anticipated by October 2022, which will help differentiate PF614 from traditional opioids.
Ensysce Biosciences has secured $8 million in funding through a convertible note agreement with institutional investors, supporting its mission to enhance opioid safety. The financing includes senior secured convertible notes and warrants, with $4 million received in an initial closing. The funds will aid in advancing clinical studies for its abuse deterrent products. The notes are convertible at a 10% premium and bear a 6% interest rate, maturing in 18 months. The company continues to prioritize developing safer prescription drugs utilizing its unique technologies.
Ensysce Biosciences has been awarded $2.8 million for the fourth year of funding from the National Institute on Drug Abuse (NIDA) for its Multi-Pill Abuse Resistance (MPAR) platform. This funding raises total NIDA support to $10.8 million, facilitating the ongoing Phase 1 clinical trial of the PF614-MPAR opioid prodrug. CEO Lynn Kirkpatrick emphasized the grant's validation of their progress in developing safer pain relief options that deter abuse and overdose. The company is focused on delivering a market-ready MPAR drug product in the future.
Ensysce Biosciences has initiated a critical study, PF614-103, to assess the intranasal abuse potential of its drug PF614 compared to oxycodone. Conducted by Dr. Glen Apseloff, the trial aims to demonstrate that PF614 cannot be manipulated for euphoric effects by drug abusers. Chief Medical Officer Dr. Nily Osman emphasized the drug's tamper-resistant features, while CEO Dr. Lynn Kirkpatrick expressed confidence in PF614's efficacy. Results from the trial are anticipated in September 2022, marking a significant advancement in Ensysce's commitment to safer opioid alternatives.
Ensysce Biosciences reported its Q1 2022 financial results with a net loss of $1.0 million, slightly higher than the $0.9 million loss in Q1 2021. Cash reserves decreased to $8.4 million from $12.3 million at year-end 2021, driven by increased operating costs. Notably, $3.1 million was spent on R&D, up from $0.3 million in the prior year. The company announced positive results from trials PF614-102 and PF614-MPAR-101, indicating advancements in their opioid products aimed at reducing abuse and overdose risks. A corporate update call is scheduled for May 17, 2022.
Ensysce Biosciences has published its 2021 Annual Shareholder Letter, authored by CEO Dr. Lynn Kirkpatrick. The company, a clinical-stage biotech firm based in San Diego, focuses on developing safer prescription drugs using its proprietary technologies, TAAP and MPAR. These platforms aim to mitigate opioid abuse and overdose risks while offering effective pain relief. The company emphasizes its commitment to innovation in drug safety, and its extensive intellectual property portfolio supports these efforts. The letter can be viewed on their official site.
Ensysce Biosciences has announced promising results from clinical trials PF614-102 and PF614-MPAR-101. The PF614-102 study, assessing a novel oxycodone prodrug, confirmed a longer-lasting profile compared to OxyContin, indicating a potential for safer, twice-daily dosing. The PF614-MPAR-101 trial revealed early data on overdose protection capabilities of the combination product. Both studies showed favorable safety profiles, supporting Ensysce's goal of creating safer pain management options. A corporate update call is scheduled for May 17, 2022, to discuss these results further.
Ensysce Biosciences (NASDAQ:ENSC, OTC PINK:ENSCW) announced its participation in two key conferences in May 2022 focusing on opioid research. Dr. William Schmidt will present at the New York Academy of Sciences on May 3, while Dr. Lynn Kirkpatrick, CEO, will discuss critical Multi-Ascending Dose clinical data on May 5 at SMi's Pain Therapeutics Conference in London. The company aims to develop safer, tamper-proof opioids through its proprietary platforms to combat prescription drug abuse and overdose.
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