Ensysce Biosciences Receives $14 Million NIH Grant for Clinical Development of Novel Opioid with Overdose Protection

Rhea-AI Summary

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.

Positive

• Received $14 million NIH grant for PF614-MPAR development
• FDA Breakthrough Therapy designation for PF614-MPAR in January 2024
• Total federal grant funding now at $40 million
• Non-dilutive funding to support Phase 1b clinical trial completion

Negative

• None.

Insights

Financial Analyst

This $14 million NIH grant is a significant financial boost for Ensysce Biosciences, bringing their total federal funding to $40 million. This non-dilutive capital infusion strengthens the company's financial position without impacting shareholder equity. The multi-year nature of the grant provides stable funding for the next three years, reducing the need for immediate capital raises.

The Breakthrough Therapy designation from the FDA earlier this year could potentially expedite the approval process, possibly leading to faster market entry and revenue generation. However, investors should note that clinical trials are still ongoing and there's no guarantee of eventual FDA approval or commercial success.

With Ensysce trading on NASDAQ, this news could positively impact stock price in the short term. Long-term value will depend on successful clinical trials and eventual commercialization of PF614-MPAR.

Medical Research Analyst

The development of PF614-MPAR represents a potentially groundbreaking approach to addressing the opioid crisis. The built-in overdose protection mechanism, which 'shuts down' opioid release if too much is consumed, could be a game-changer in pain management.

The upcoming Phase 1b clinical trial will be important in expanding on the initial findings from the PF614-MPAR-101 study. If successful, this could position PF614-MPAR as the first opioid with oral overdose protection, a significant advancement in the field.

However, it's important to note that we're still in early clinical stages. While the Breakthrough Therapy designation is promising, extensive testing is still required to prove long-term safety and efficacy. The potential application of MPAR® technology beyond opioids also opens up exciting possibilities for drug safety across various therapeutic areas.

Market Research Analyst

The market potential for a safer opioid with built-in overdose protection is substantial. With the CDC reporting nearly two overdose deaths per hour, there's a clear unmet need in pain management. If PF614-MPAR proves successful, it could capture a significant share of the opioid market, estimated to be worth billions globally.

However, market adoption may face challenges. Healthcare providers might be cautious about prescribing new opioid formulations and insurance companies may initially limit coverage. Patient education will be important to highlight the safety benefits of PF614-MPAR.

The broader application of MPAR® technology beyond opioids could open up additional market opportunities, potentially positioning Ensysce as a leader in drug safety innovation. This could attract partnership or acquisition interest from larger pharmaceutical companies looking to enhance their pain management portfolios.

~ Substantial Award Follows FDA Breakthrough Therapy Designation for PF614-MPAR ~

~ Federal Grant Funding Awarded to Date Now at $40 Million ~

SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced receipt of 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 that received Breakthrough Therapy designation from the FDA in January 2024. Funding from this award will be available over a period of approximately three years, allowing for the completion of the Phase 1b clinical trial, PF614-MPAR-102. This Phase 1b study is designed to expand the product offering identified in the PF614-MPAR-101 study, the first study to verify the overdose protection of the Multi-Pill Abuse Resistance (MPAR^®) platform. Combined, the two studies will help position PF614-MPAR as the first opioid product with oral overdose protection.

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences, commented, "This non-dilutive award by NIDA is another meaningful vote of support by the federal government for the development of this novel class of opioids with overdose protection. Our initial Phase 1 study of PF614-MPAR demonstrated this approach to treat pain provides protection from taking too many pills orally. With this funding, adding to the two prior grants of over $26 million for the initial work on the MPAR and opioid use disorder (OUD) programs, Ensysce intends to quickly drive PF614-MPAR through clinical development to make its benefits available in a large market where we believe unmet need is high."

PF614-MPAR is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by ‘shutting down' opioid release if too much active drug is consumed. PF614-MPAR could herald a new class of treatment for the most severe forms of pain and could save lives, as each capsule contains built-in protection against both abuse and overdose which plague traditional opioids. Safer opioids for severe pain which protect against abuse and oral overdose are vital to address the discouraging statistics from the Centers for Disease Control of almost two overdose deaths per hour. Ensysce is forging the way to reverse this trend with two new opioids in clinical development. The MPAR^® technology may also have applications for improving drug safety beyond opioids.

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 purpose of Ensysce Biosciences' PF614-MPAR?

PF614-MPAR is designed to provide optimal pain relief at prescribed doses while limiting accidental or intentional overdose by 'shutting down' opioid release if too much active drug is consumed. It aims to be a safer opioid for severe pain with built-in protection against both abuse and oral overdose.

How much funding did Ensysce Biosciences (ENSC) receive from NIH?

Ensysce Biosciences received a $14 million multi-year grant from the NIH and National Institute on Drug Abuse (NIDA) for the continued development of PF614-MPAR.

What is the significance of the FDA Breakthrough Therapy designation for PF614-MPAR?

The FDA Breakthrough Therapy designation, received in January 2024, indicates that PF614-MPAR may demonstrate substantial improvement over existing therapies for severe pain relief with reduced potential for opioid abuse and overdose.

What clinical trial will the NIH grant fund for Ensysce Biosciences (ENSC)?

The NIH grant will fund the completion of the Phase 1b clinical trial, PF614-MPAR-102, which is designed to expand the product offering identified in the previous PF614-MPAR-101 study.