Ensysce Biosciences Continues Collaboration to Advance the Clinical Development of Innovative Overdose Protection Platform
Ensysce Biosciences has renewed its collaboration with Quotient Sciences to advance the clinical development of its overdose protection platform, PF614-MPAR. This innovative opioid product, designed to prevent overdose by shutting off opioid release when too many pills are ingested, is undergoing a Phase 1b study to evaluate its efficacy and safety across different doses. The study, PF614-MPAR-102, will assess doses of 25 mg, 50 mg, and 100 mg administered twice daily for five days. PF614-MPAR, which has received Breakthrough Therapy designation from the FDA, aims to provide a safer solution for severe pain management and address the ongoing opioid overdose crisis in the U.S.
- Renewed collaboration with Quotient Sciences to advance clinical development.
- PF614-MPAR received Breakthrough Therapy designation from FDA.
- Launch of Phase 1b study to assess full dosage range.
- Potential to address opioid overdose crisis with innovative overdose protection.
- Quotient Sciences' Translational Pharmaceutics® platform to expedite clinical trials.
- No financial details or funding information disclosed.
- Risk associated with clinical trials not being successful.
- Potential delays in clinical study results impacting timelines.
- Regulatory hurdles and approval processes remain challenging.
Insights
Ensysce Biosciences' PF614-MPAR drug product continues to show promise in addressing the opioid epidemic. The renewal of the collaboration with Quotient Sciences to advance the clinical development of this product signals a significant step forward. The Phase 1b study will evaluate how PF614-MPAR releases opioids at various doses, ensuring both effectiveness and overdose protection.
The innovative Multi-Pill Abuse Protection (MPAR) technology is particularly noteworthy. It is designed to shut off opioid release if too many pills are ingested, making it a potentially revolutionary tool in combatting deliberate or accidental overdose. This feature aligns well with the FDA's Breakthrough Therapy designation, meaning the drug is being developed for serious conditions and has demonstrated substantial improvement over existing therapies.
For investors, the successful progress of this clinical trial could translate into a
The renewal of Ensysce Biosciences' collaboration with Quotient Sciences is likely a positive development for the company's stock. The ongoing study of PF614-MPAR demonstrates Ensysce's commitment to bringing a vital, innovative product to market. Given that the drug has been granted Breakthrough Therapy designation by the FDA, it is on an expedited path for approval, which could accelerate revenue generation.
Investors should consider that the opioid crisis presents a significant market opportunity. If PF614-MPAR can effectively mitigate overdose risks, it could capture a substantial share of the opioid market. Nevertheless, the financial success of Ensysce hinges on clinical trial results and subsequent FDA approval. Additionally, scaling production and distribution could require substantial capital, potentially impacting near-term profitability.
Short-term, positive trial results could boost stock prices, while long-term success depends on regulatory approval and market adoption. Investors should weigh these factors carefully while considering their positions.
New Study to Confirm Overdose Protection Across Full Dosage Range of Breakthrough Therapy Opioid PF614-MPAR
SAN DIEGO, CA / ACCESSWIRE / May 20, 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 the renewal of its collaboration with Quotient Sciences to undertake the study PF614-MPAR-102 to examine and evaluate the full commercial dose range of the PF614-MPAR drug product.
PF614-MPAR is the Company's Multi-Pill Abuse Protection (MPAR) unique combination opioid product which shuts off opioid release when too many pills are ingested, thereby stopping deliberate or accidental overdose. This ground-breaking technology has the potential to save many lives and was recently granted Breakthrough Therapy designation by the U.S. Food & Drug Administration (FDA).
The Phase 1b study, PF614-MPAR-102, will evaluate opioid release following administration of PF614-MPAR at doses of 25 mg, 50 mg and 100 mg delivered twice daily for 5 days to verify both overdose protection and effective delivery of oxycodone. The study will apply the Quotient Sciences Translational Pharmaceutics® platform to manufacture and test the PF614-MPAR drug product to expedite the clinical study process.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, remarked, "My team is delighted to continue our partnership with Quotient Sciences and the use of their unique approach to drug product optimization. Our aim is to provide prescribers and patients with an innovative, safer choice to treat severe pain and reduce substantial concern of overdose. As prescription opioid overdoses remain a critical issue in America, the resultant regulatory restrictions are now causing supply issues for patients in severe pain. The potential benefits of our MPAR platform were highlighted by Dr. Rick Dart at the PAINWeek conference in 2023."
About Breakthrough Therapy
Breakthrough Therapy is a rarely used designation, having been granted to fewer than 300 drugs since the category was established 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.
About Quotient Sciences
Quotient Sciences is a global drug development and manufacturing accelerator that supports companies across the drug development pathway. They provide integrated contract research, development, and manufacturing services for many of the leading global pharma and biotech companies, bringing deep expertise and insight to the development process. The Quotient partnership was instrumental in aiding the development of the first PF614-MPAR 25 mg dosage form using their unique "Translation Pharmaceutics®" process.
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™) 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.
Definitions
TAAP: trypsin activated abuse protection - designed to protect against prescription drug abuse.
MPAR: multi-pill abuse resistance - designed to protect against abuse and accidental overdose.
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, possible Nasdaq delisting; 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
View the original press release on accesswire.com
FAQ
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