By Brad Sorensen, CFA
NASDAQ:ENSC
READ THE FULL ENSC RESEARCH REPORT
Ensysce Biosciences (NASDAQ:ENSC) is a clinical stage company that is developing novel opioids that provide the needed pain relief, while greatly limiting the potential for abuse and overdoses that have plagued the American public.
Company management has recently announced that it has received international patents for its technology that we believe expands its patient impact potential as well as the commercial opportunity for the company. First, the company’s ADHD therapy with built-in abuse and overdose protection received a Notice of Allowance from the European Patent Office for the issuance of a patent. According to the company, this newly allowed patent, covering both composition of matter and method of use claims, adds to the Ensysce patent portfolio and secures its subject-matter authority in developing safer treatments for ADHD, a condition affecting millions of children and adults worldwide.
As a reminder, amphetamine stimulants remain the standard of care for ADHD but carry well-documented risks of abuse, dependence, and overdose. Approximately 3.9 million people aged 12 or older misused prescription stimulants in 2023, according to the Department of Health and Human Services. The company’s treatment, PF8026, is another drug candidate in a new class of ADHD medications that directly address these risks. Unlike traditional formulations, Ensysce's prodrug design prevents common abuse routes such as nasal inhalation and incorporates MPAR overdose protection, which we have written about extensively and has extensive positive test results.
Second, the company received a Notice of Allowance from the Brazilian Patent Office for the issuance of a patent covering additional opioid families, utilizing the company's proprietary TAAP and MPAR technologies. The combination of these two announcements furthers our belief in the future extensive and growing revenue opportunities for the company.
This builds on other recent developments, such as an announcement late last year that it has enrolled the first patient in the pivotal Phase 3 clinical trial of PF614—the company’s lead product candidate. As a reminder to investors new to the ENSC story, which is one we’re very excited about, the company is developing a next-generation opioid therapy that combines effective analgesia with built-in protection against both abuse and overdose—a rare and compelling value proposition in our view. PF61 leverages a proprietary technology called TAAP (“Trypsin-Activated Abuse Protection”), which renders oxycodone inactive until it reaches the small intestine, significantly reducing its potential for misuse. This is not just a reformulation; it's a fundamental rethinking of how opioids can be delivered with safety in mind. The commencement of a Phase 3 trial is a major milestone on the way to potential commercialization and redefining pain care.
But Ensysce isn’t stopping there: building on PF614, they have created PF614-MPAR, a combination therapy that adds MPAR (“Multi-Pill Abuse Resistance”) technology. This innovation is designed to “switch off” further opioid release when more than the prescribed dose is taken, effectively activating an overdose protection mechanism. It’s a breakthrough in concept—and importantly, the U.S. Food and Drug Administration has recognized its potential, granting Breakthrough Therapy designation.
Beyond pain management, Ensysce is expanding its impact into the treatment of opioid use disorder (OUD). Their lead OUD candidate, PF9001, combines the TAAP and MPAR platforms to potentially offer a safer methadone alternative—with oral delivery, reduced cardiovascular risk, and built-in overdose protection. They recently secured a U.S. patent for PF9001, adding strength to their intellectual property portfolio.
Strategically, Ensysce’s management is executing with discipline. Their manufacturing partnerships for PF614 and PF614-MPAR are already in place, positioning the company for efficient scale-up once regulatory approvals move forward. Their collaborative relationship with the FDA, especially around the overdose protection labeling and streamlined regulatory path, underscores not only scientific innovation but also regulatory savvy and further underscores the positive path management is pursuing.
We have written for some time how important the work ENSC is doing is, and continue to believe that. We also believe that investors who invest in such important work have the potential to be rewarded quite well as these solutions to a problem plaguing thousands of families come to fruition. We encourage investors to take a look at ENSC and consider the stock before the anticipated positive testing results from this current trial begin to come in.
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