Ensysce Biosciences Receives Notice of Award for 4th Year of Funding for Its Multi-Pill Abuse Resistance (MPAR(TM)) Platform

Rhea-AI Summary

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.

Positive

• Secured $2.8 million in grant funding from NIDA, totaling $10.8 million.
• Funding supports ongoing Phase 1 clinical trial for PF614-MPAR product.
• Demonstrated overdose protection in recent clinical studies.

Negative

• None.

SAN DIEGO, CA / ACCESSWIRE / June 27, 2022 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC) (OTC:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance focused on reducing abuse and overdose, today announced the Company has received a notice of award for the 4^th year of funding of a multi-year grant from the National Institute on Drug Abuse (NIDA) for its Multi-Pill Abuse Resistance (MPAR™) Platform. The amount awarded is $2.8 million and the budget start date is July 1, 2022. This brings total funding from NIDA under this grant to $10.8 million. The funding will support the third part of the ongoing Phase 1 clinical trial evaluating the MPAR™ platform.

Lynn Kirkpatrick, CEO of Ensysce Biosciences, commented, "We are honored to receive the final year of the UH3DA047682 award titled ‘PF614 MPAR Abuse Deterrent opioid prodrug with overdose protection: Pre-Clinical Development and Phase 1 Clinical Trial' allowing us the continued resources to bring PF614-MPAR^TM through early clinical development. The receipt of this funding validates our significant progress to date as we move towards realizing our goal of delivering superior pain relief options while also providing abuse and overdose protection for opioid products. Importantly, this is further confirmation of NIDA recognizing the importance and benefits of our TAAP^TM and MPAR^TM technologies."

PF614-MPAR™ is designed as an extended-release oxycodone prodrug with both trypsin-activated abuse protection (TAAP^TM) and overdose protection through multi-pill abuse resistance (MPAR™) technology. TAAP^TM chemical modification inactivates the active ingredient in PF614 to provide abuse deterrence, and the combination with the trypsin inhibitor, nafamostat, in MPAR™ provides the additional layer of overdose protection.

As recently reported, the PF614-MPAR-101 overdose protection study examined PF614 administered orally alone or in combination with the trypsin inhibitor nafamostat (MPAR) to healthy volunteers. The early data demonstrated the overdose protection of our MPAR combination product, with reduced release of oxycodone from PF614 in a simulated overdose situation. It also demonstrated the PF614 in the systemic circulation (simulated injection) did not convert to oxycodone. Ensysce believes this is a major step in identifying the first MPAR drug product that will be marketed in the coming years.

About Ensysce Biosciences

Ensysce Biosciences, based in San Diego, CA is a clinical-stage biotech company using its two novel proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR™) platforms, the Company is seeking to develop next-generation, tamper-proof opioids that prevent both drug abuse and overdoses. Ensysce's products are anticipated to provide safer options to treat severe pain and assist in preventing deaths caused by opioid abuse, reducing the human and economic costs. The platforms are covered by an extensive worldwide intellectual property portfolio encompassing a wide array of prescription drugs. For more information, please visit www.ensysce.com.

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," and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinical development and are 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 annual report on Form 10-K 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.

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FAQ

What is the recent funding announcement for Ensysce Biosciences?

Ensysce Biosciences received $2.8 million from NIDA for the fourth year of funding for its MPAR platform.

How much total funding has Ensysce received from NIDA?

Ensysce has now received a total of $10.8 million from NIDA.

What is the PF614-MPAR and its purpose?

PF614-MPAR is an extended-release oxycodone prodrug designed to deter abuse and prevent overdose.

What are the key clinical findings related to PF614-MPAR?

Early data indicates that the MPAR combination reduces oxycodone release in simulated overdose situations.

What potential market impact does this funding have for ENSCW?

The funding may enhance the path to commercialize PF614-MPAR, impacting investor interest positively.