Ensysce Biosciences Announces Partnership to Scale and Manufacture New Drug Candidate
Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company, announced a partnership with manufacturing expert Purisys to scale the production of its lead opioid use disorder (OUD) drug candidate, PF9001. Developed using Ensysce's TAAP technology, PF9001 aims to reduce the cardiovascular side effects commonly associated with methadone. This collaboration aims to expedite the drug's progression to IND studies. Ensysce is also advancing its pain treatment candidate, PF614, towards Phase 3 trials. CEO Dr. Lynn Kirkpatrick highlighted Purisys' expertise in controlled substance chemistry and its role in improving the manufacturing processes for PF614.
- Partnership with Purisys to scale PF9001 manufacturing.
- PF9001 targets OUD with fewer cardiovascular side effects than methadone.
- Progression of PF614 to Phase 3 trials for severe pain treatment.
- TAAP technology enables the expansion of Ensysce's drug pipeline.
- No specific financial metrics or timelines for trial completion provided.
Insights
Ensysce Biosciences is taking a major step forward with its partnership with Purisys, setting the stage for scaling and manufacturing its leading OUD drug candidate, PF9001. For investors, this collaboration suggests that Ensysce is moving closer to initiating clinical trials, which is a pivotal milestone in drug development. By joining forces with Purisys, known for their expertise in synthetic compound manufacturing, Ensysce is mitigating some of the risks associated with drug production and ensuring a reliable supply chain.
From a financial perspective, successful progression to clinical trials could potentially lead to significant
The strategic alliance with Purisys is significant for Ensysce's medical research trajectory. With PF9001 targeting opioid use disorder (OUD), a condition with substantial medical and economic burdens, advancing to clinical trials holds promise. Ensysce’s TAAP technology, which aims to mitigate cardiovascular side effects and reduce opioid abuse potential, stands out in the current pharmaceutical landscape. This technological edge might offer a safer alternative to methadone, potentially transforming OUD treatment paradigms.
However, the pathway to proving these benefits in clinical settings remains challenging and resource-intensive. Critical to watch will be the IND (Investigational New Drug) submission and subsequent trial results. Positive outcomes could validate TAAP technology's efficacy, possibly attracting further investments and strategic partnerships, but the inherent risks typical of clinical trials shouldn’t be underestimated.
~ Collaboration with Purisys Positions Ensysce to Expedite Lead OUD Candidate, PF9001, to IND Studies ~
SAN DIEGO, CA / ACCESSWIRE / June 25, 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 an agreement with Purisys LLC ("Purisys") to scale the manufacture of the Company's lead opioid use disorder (OUD) drug candidate. PF9001, as recently announced, is a novel agent developed with Ensysce's unique TAAP technology to treat OUD that will potentially decrease the cardiovascular side effects associated with methadone. Purisys brings experience with established manufacturing expertise specializing in commercial scale supply of complex synthetic compounds specifically in controlled substance chemistry.
Dr. Lynn Kirkpatrick, CEO of Ensysce, said, "As we continue to progress to Phase 3 with our lead candidate to treat severe pain, PF614, we are simultaneously making significant strides advancing our OUD program. We recognize the advantage of being able to expand our pipeline of drug candidates using our TAAP technology and are looking forward to bringing PF9001 into clinical trials in the coming year. We are especially pleased to partner with manufacturing leader Purisys and its skilled team of scientists and engineers who have also made great strides with improving the manufacture of lead product PF614. We appreciate Purisys' expertise, and we look forward to advancing toward larger non-clinical and clinical studies with PF9001."
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 (TAAPTM) 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 Purisys
Headquartered in Athens Georgia, Purisys is a leading supplier of API CDMO services and pharmaceutical reference standards. Its 17,000-square-foot manufacturing facility and innovation center is staffed by scientists, engineers, and other professionals who have decades of experience in complex high-barrier custom synthetic chemistry. Purisys' CDMO services are designed to support the development of custom APIs for a wide range of clinical and niche commercial applications. Purisys has specialized capabilities in controlled substance APIs, possessing 6 DEA registrations encompassing 48 drug codes. Purisys stocks a catalog of more than 250 commercial reference standards that support pharmaceutical drug product development and manufacturing.
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.
View the original press release on accesswire.com
FAQ
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