Ensysce Biosciences Announces IRB Approval for Key MPAR Study

Rhea-AI Summary

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.

Positive

• Received IRB approval for PF614-MPAR-102 protocol
• Secured $14 million federal grant to support clinical trials
• PF614-MPAR has FDA Breakthrough Therapy designation
• Only opioid with both abuse and overdose protection to receive Breakthrough Therapy status
• Collaboration with Quotient Sciences for clinical study using Translational Pharmaceutics® platform

Negative

• First data from the new trial not expected until mid-2025

Insights

Medical Research Analyst

The IRB approval for Ensysce's PF614-MPAR-102 protocol marks a significant milestone in the development of a novel opioid with dual protection against abuse and overdose. This unique approach addresses critical safety concerns in pain management. The $14 million grant from NIDA underscores the potential impact of this technology on public health. The FDA's Breakthrough Therapy designation, granted to only ~0.1% of drugs, highlights the exceptional promise of PF614-MPAR. This accelerated pathway could lead to faster market entry, potentially revolutionizing severe pain treatment while mitigating opioid crisis risks.

Financial Analyst

Ensysce's progress with PF614-MPAR presents a compelling investment case. The $14 million government grant significantly reduces financial risk and demonstrates strong federal support. The Breakthrough Therapy designation could lead to expedited FDA review, potentially shortening time-to-market and reducing development costs. However, investors should note that clinical success is not guaranteed and the timeline to revenue generation remains uncertain. The opioid market is highly competitive, but Ensysce's unique dual-protection approach could provide a substantial market advantage if approved, potentially leading to strong revenue growth and market share gains.

Pharmaceutical Industry Expert

Ensysce's PF614-MPAR represents a potential game-changer in the opioid market. The combination of abuse deterrence and overdose protection addresses two critical issues simultaneously, a unique selling proposition in this space. The collaboration with Quotient Sciences utilizing their Translational Pharmaceutics® platform could accelerate development and optimize formulation. The expected data release in mid-2025 will be a crucial inflection point. If successful, PF614-MPAR could reshape prescribing patterns for severe pain management, potentially becoming a first-line treatment due to its enhanced safety profile. This could lead to significant market penetration and potentially disrupt current market leaders.

Next Clinical Trial of FDA Breakthrough Therapy PF614-MPAR Supported by $14 Million Federal Government Grant

SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has received Investigational Review Board ("IRB") approval of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' Ensysce has continued its collaboration with Quotient Sciences to conduct this second clinical study of MPAR using their Translational Pharmaceutics® platform.

Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "The approval of this study protocol represents another key milestone towards completing the clinical development of our first-in-class opioid with both abuse and overdose protection. Clinical data from our initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA designation of Breakthrough Therapy. PF614-MPAR is the only opioid to receive such recognition and one of only ~300 drugs ever approved for this designation. We remain dedicated to bringing to market a new generation of safer products to alleviate the suffering of those who experience severe pain."

Dr. Lynn Kirkpatrick, CEO of Ensysce, offered, "We are pleased to have IRB approval that allows us to quickly start this second clinical study of PF614-MPAR. This program not only has FDA support but is also supported by the National Institute on Drug Abuse with today's announcement of a $14 million multi-year award to Ensysce. This award allows us to complete this clinical trial and necessary non-clinical studies for both PF614 and the combination with nafamostat. Additionally, the Breakthrough Therapy designation of PF614-MPAR permits frequent interactions with the FDA which are pivotal to maintain a relatively smooth path to registration. We look forward to initiating this three-part trial immediately and expect to announce first data in mid-2025."

About Ensysce Biosciences

Ensysce Biosciences is a clinical stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP^TM) and Multi-Pill Abuse Resistance (MPAR^®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.

About Breakthrough Therapy Designation

Breakthrough Therapy is a rarely used designation, having been granted by the FDA to fewer than 300 drugs since its introduction in 2012. It is designed to expedite the development and review of drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.

Forward-Looking Statements

Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.

Ensysce Biosciences Company Contact:
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196

Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us

SOURCE: Ensysce Biosciences Inc.

View the original press release on accesswire.com

FAQ

What is the significance of the IRB approval for Ensysce Biosciences (ENSC)?

The IRB approval allows Ensysce Biosciences to proceed with the PF614-MPAR-102 clinical study, which is important for developing their innovative opioid with abuse and overdose protection. This approval is a key milestone in bringing their FDA-designated Breakthrough Therapy closer to market.

How much funding did Ensysce Biosciences (ENSC) receive for the PF614-MPAR clinical trials?

Ensysce Biosciences received a $14 million multi-year award from the National Institute on Drug Abuse to support the clinical trials for PF614-MPAR and necessary non-clinical studies.

When does Ensysce Biosciences (ENSC) expect to announce the first data from the PF614-MPAR-102 trial?

Ensysce Biosciences expects to announce the first data from the PF614-MPAR-102 trial in mid-2025.

What makes PF614-MPAR unique among opioid treatments?

PF614-MPAR is the only opioid with both abuse and overdose protection to receive FDA Breakthrough Therapy designation, making it a first-in-class treatment for severe pain relief.