Ensysce Biosciences Announces Critical Step in Human Abuse Potential Study of PF614 With Database Lock
Ensysce Biosciences (NASDAQ:ENSC) has locked its database for the oral Human Abuse Potential (HAP) study of PF614, a controlled-release oxycodone product, on February 24, 2023. This pivotal study is essential for obtaining Abuse Deterrent labeling from the FDA. Following unblinding on February 27, 2023, results are scheduled for release by the end of March 2023. The company leverages its Trypsin Activated Abuse Protection (TAAP) technology to develop safer pain management options that mitigate risks of abuse and overdose.
- Database lock for PF614 study indicates progress towards FDA approval.
- Anticipated results by the end of March could positively influence stock performance.
- No assurance that clinical programs will demonstrate safety or efficacy.
- Potential delays in clinical development could impact timelines.
Company Remains on Track to Report Results the End of March
SAN DIEGO, CA / ACCESSWIRE / February 28, 2023 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose, today announced the database lock on February 24, 2023 for the oral Human Abuse Potential (HAP) study of PF614. PF614 is a TAAP™ (Trypsin Activated Abuse Protection) product to treat severe pain. With the database lock, no further change to the trial data is permissible such that all clinical trial data is concluded with all subjects' information being complete, accurate, consistent and free from discrepancy. This key study, PF614-104, is being conducted by Dr. Vince Clinical Research.
The PF614-104 trial was designed to evaluate the abuse potential, drug liking and pharmacokinetics of oral administration of PF614 (controlled-release oxycodone TAAP™ prodrug) versus immediate-release oxycodone HCl in non-dependent, recreational drug users. HAP studies are critical for gaining Abuse Deterrent labeling as outlined by the FDA. Unblinding of the study data began on February 27, 2023 and the Company remains on track to report results by the end of March.
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage biotech company using its 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 in the process of developing a unique, tamper-proof treatment option for pain that minimizes the risk of both drug abuse and overdoses. 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.
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:
MZ Group North America
Shannon Devine
203-741-8811
ENSC@mzgroup.us
SOURCE: Ensysce Biosciences, Inc.
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