Ensysce Biosciences Inc Stock Price, News & Analysis

Ensysce Biosciences (NASDAQ:ENSC) has received IRB approval for the PF614-MPAR-102 protocol, marking a significant milestone in the clinical development of their FDA-designated Breakthrough Therapy for severe pain relief. This study, supported by a $14 million federal grant, will evaluate the pharmacokinetics of oxycodone and PF614 when co-administered with nafamostat. PF614-MPAR is unique as the only opioid with both abuse and overdose protection to receive Breakthrough Therapy designation. The company plans to initiate the three-part trial immediately, with first data expected in mid-2025. This development brings Ensysce closer to introducing a new generation of safer pain management products.

Ensysce Biosciences (NASDAQ:ENSC) has received a $14 million multi-year grant from the NIH and National Institute on Drug Abuse (NIDA) for the continued development of PF614-MPAR, an abuse-deterrent opioid with overdose protection. This follows the FDA's Breakthrough Therapy designation for PF614-MPAR in January 2024. The funding will support the completion of the Phase 1b clinical trial, PF614-MPAR-102, over approximately three years.

PF614-MPAR is designed to provide optimal pain relief at prescribed doses while limiting accidental or intentional overdose. This grant brings the total federal funding awarded to Ensysce to $40 million, supporting their mission to develop innovative solutions for severe pain relief with reduced potential for opioid abuse and overdose.

Ensysce Biosciences (NASDAQ:ENSC) reported Q2 2024 financial results and provided updates on its opioid programs. Key highlights include:

• PF614-MPAR advancing to Phase 1b study
• PF9001 selected as lead candidate for Opioid Use Disorder program
• PF614 Phase 3 protocol being finalized for FDA submission
• Q2 cash position of $1.0 million
• Q2 net loss of $2.0 million, down from $2.2 million in Q2 2023
• R&D expenses decreased to $0.9 million from $1.6 million year-over-year

The company is progressing its TAAP™ and MPAR® technologies to develop safer opioid analgesics with abuse deterrent and overdose protection features.

Ensysce Biosciences (NASDAQ:ENSC) hosted a successful symposium at the International Association for the Study of Pain (IASP) 2024 World Congress in Amsterdam. The symposium, titled 'Severe Pain: A New Chapter for Safer Analgesics', focused on innovative solutions for severe pain relief while reducing opioid abuse and overdose risks. Key discussions included:

1. Current landscape of severe pain treatment
2. new therapeutic agents in the past decade
3. Pros and cons of opioid use and genetic influences on pain
4. Ensysce's Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) technologies
5. Safety and effectiveness of PF614 and PF614-MPAR
6. Upcoming clinical studies and commercial positioning

The symposium received positive feedback on its content and Ensysce's clinical strategy.

Ensysce Biosciences (NASDAQ:ENSC) provides a mid-year 2024 update on its clinical-stage pharmaceutical developments for severe pain relief with reduced opioid abuse and overdose potential. Key highlights include:

1. PF614: Completed End of Phase 2 FDA meeting, published bioequivalence study results, and established manufacturing partnerships.

2. PF614-MPAR: Received FDA Breakthrough Therapy designation, applied for $15 million NIH/NIDA grant, and advanced to second clinical trial.

3. Opioid Use Disorder (OUD) program: Selected lead drug candidate PF9001, a TAAP methadone analogue with potentially lower cardiovascular side effects.

The company is finalizing the PF614 Phase 3 protocol and anticipates initiating enrollment later in 2024. Ensysce continues to seek non-dilutive federal funding to support its innovative pain relief solutions.

Ensysce Biosciences (NASDAQ:ENSC) announced it will host a symposium at the IASP 2024 World Congress on Pain on August 8, 2024, in Amsterdam. The symposium titled 'Severe Pain: A New Chapter for Safer Analgesics' will feature Dr. Lars Arendt-Nielsen and Dr. William Schmidt, who will discuss the landscape of severe pain treatment, trends in treatment, and the safety and effectiveness of Ensysce's PF614 and PF614-MPAR based on clinical data. CEO Dr. Lynn Kirkpatrick emphasized the importance of the event for presenting their technology platforms, TAAP and MPAR, which aim to reduce prescription drug abuse and overdose.

Ensysce Biosciences, a clinical-stage pharmaceutical company (NASDAQ: ENSC), shared key insights from the 2024 EPHMRA Annual Meeting, held in London on June 25-26. Geoff Birkett, Chief Commercial Officer, participated in discussions about the future of healthcare research and emphasized the importance of new technologies in addressing pain and opioid abuse. Ensysce's TAAP™ and MPAR® platforms were highlighted as examples of innovative solutions. Birkett also led a session on integrating AI and human intelligence in drug development, underscoring the need for active involvement from company staff and prescribers. He expressed optimism about the potential of advanced technologies to improve patient lives and stressed the ongoing importance of research in drug development. Additionally, the meeting reinforced the significance of combining AI with human insights.

Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company, announced a partnership with manufacturing expert Purisys to scale the production of its lead opioid use disorder (OUD) drug candidate, PF9001. Developed using Ensysce's TAAP technology, PF9001 aims to reduce the cardiovascular side effects commonly associated with methadone. This collaboration aims to expedite the drug's progression to IND studies. Ensysce is also advancing its pain treatment candidate, PF614, towards Phase 3 trials. CEO Dr. Lynn Kirkpatrick highlighted Purisys' expertise in controlled substance chemistry and its role in improving the manufacturing processes for PF614.

Ensysce Biosciences (NASDAQ: ENSC) has achieved a critical milestone in its opioid use disorder (OUD) program. The company has selected PF9001, a lead drug candidate designed to reduce abuse potential and improve safety, particularly with lower cardiovascular risks compared to traditional treatments. The candidate will proceed to Investigational New Drug (IND) enabling studies, backed by a $15 million NIH and NIDA HEAL award. CEO Dr. Lynn Kirkpatrick highlighted the adaptability of Ensysce's TAAP technology in producing controlled-activation drug candidates. Human clinical studies are expected to begin within 12 to 18 months.