Ensysce Biosciences is making strides in the development of its next-generation analgesics, PF614 and PF614-MPAR, designed to provide safer and more effective pain relief. The company's lead candidate, PF614, an extended-release formulation of oxycodone utilizing the TAAP™ technology, has completed several clinical trials and non-clinical studies, paving the way for discussions with the FDA regarding Phase 3 trial design. These discussions are scheduled for January 30, 2024.
PF614: Extended-Release Oxycodone for Severe Pain
PF614 aims to address the needs of patients suffering from severe pain, offering a bioequivalent alternative to OxyContin with a potentially improved pharmacokinetic profile. Clinical data suggests that PF614 has a longer half-life than OxyContin, which could translate to enhanced pain-relieving qualities and a convenient twice-daily dosing regimen.
In April, Ensysce announced positive results from the PF614-104 study, which evaluated the oral abuse potential of PF614. The study met its key endpoints, demonstrating that oral administration of PF614 resulted in significantly lower scores for "Overall Drug Liking" and willingness to "Take Drug Again" compared to the oxycodone comparator. Furthermore, a study to measure the onset of pain relief for PF614 showed the time-of-efficacy-onset of PF614 and its ability to reduce pain intensity.
PF614-MPAR: Overdose Protection Technology
In parallel with PF614, Ensysce is also developing PF614-MPAR, which incorporates the MPAR® technology designed to prevent opioid overdose. The MPAR® technology reduces the release of oxycodone from the TAAP prodrugs in the event of an overdose, potentially saving lives. According to the CDC, nearly 280,000 people in the United States died from overdoses involving prescription opioids between 1999 and 2021.
Clinical data from the Phase 1 study, PF614-MPAR-101, demonstrated that PF614-MPAR delivered oxycodone appropriately when one or two doses were consumed but reduced opioid delivery when three or more doses were taken orally, simulating an overdose situation. A regulatory submission has been made to discuss the MPAR development program with the FDA, with a meeting scheduled for February 20, 2024.
Expanding the Pain Portfolio
Ensysce is also exploring opportunities to diversify its portfolio of pain agents outside of opioids. The company has announced a Letter of Intent with OncoZenge AB, a Swedish company, to develop BupiZenge, a bupivacaine lozenge for treating pain associated with oral mucositis caused by cancer treatment. BupiZenge has already demonstrated efficacy in four clinical trials in Europe, and Ensysce aims to bring it through FDA approval and commercialization in the United States.
Financial and Operational Highlights
In 2023, Ensysce completed three financing transactions, raising a total of $12 million to support the advancement of its clinical trial programs. The company is focused on near-term discussions with the FDA regarding the Phase 3 protocol design for PF614 and is continuing regulatory discussions for PF614-MPAR. Ensysce aims to expedite regulatory approval through the 505(b)(2) pathway and expand the use cases of its TAAP™ and MPAR® technology platforms.
