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.
In pursuit of that goal, the company released data from a study on its PF614-MPAR compound that is designed to treat pain and provide overdose protection. In the study, subjects received up to five 100 mg doses of the overdose-protected PF614-MPAR versus the unprotected PF614. The data showed that the maximum amount of oxycodone released from PF614-MPAR, when three or more doses were taken at one time was reduced compared to that released following the consumption of the same amount of PF614 alone, evidence of overdose protection. When five doses of PF614-MPAR were administered, overdose protection was appropriately greater than that observed from three dose units. Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR.
This data further confirms our belief that ENSC is developing a potentially game-changing treatment that could change patients’ lives by providing much-needed pain relief, while greatly reducing the risk of abuse. Company management noted that they will use this data in discussions with the FDA regarding the full development plan for this compound.
Illustrating the belief in this treatment, in 2024, the company announced that it has received a $14 million grant from the National Institute of Health (NIH) for the continued clinical development of PF614-MPAR—the company’s abuse-deterrent opioid with overdose protection. The award will be paid over three years and, according to the company, allow for the completion of crucial clinical trials. This award creates multiple positive impacts for the company. First, the money from the grant will help fund operations and further clinical testing, while allowing the company to limit future potential dilution to shareholders. Additionally, the award represents, in our view, another positive vote from a respected medical organization that has seen the initial data and believes in the potential benefits of this treatment.
Management also recently noted that it has received positive feedback on its Phase 3 study design for PF614 and is planning on starting enrollment in this crucial study in 2Q2025. Management also noted that the company remains on track for a New Drug Application submission in 2026. Additionally, earlier this year, the company announced a critical partnership for the manufacturing and commercialization of both of the company’s products.
We aren’t going to rehash recent reports that have outlined the positive test results for PF614 and PF614-MPAR. But, as a reminder, these tests have shown that PF614 can provide the much-needed pain relief that is currently available through the highly abused oxycodone, while having abuse resistant properties and lasting longer. Additionally, an important reminder that PF-614-MPAR received an FDA grant of Breakthrough Therapy designation, which allows ENSC the opportunity to accelerate clinical programs and commercialization plans. The grant, which has been applied to fewer than 300 drugs historically, illustrates the importance and urgency that these solutions are needed. We are again reiterating our belief that the treatments being developed by Ensysce will be game changers in the pain relief market and again suggest that investors take a strong look at ENSC.
PF614-MPAR has been shown in testing to have the potential to provide much needed pain relief to patients and provides protections against taking too many pills, which often leads to debilitating addiction. The technology involved causes the drug to become inactive when dosing requirements are exceeded—greatly diminishing the “incentive” patients may have to take more than the prescribed dose.
Ensysce Biosciences continues to be one of the companies that we cover that we believe most of America would hope is successful and one we are becoming more convinced will achieve its goals. The opioid crisis remains a plague on the American public and is destroying families and entire communities. The National Institute on Drug Abuse reported more than 107,000 overdose deaths in 2022—and that doesn’t count the millions of family members and friends impacted by those deaths. Ensysce has extremely promising technology in the form of PF614 and PF614-MPAR that are abuse resistant, while still providing the much-needed pain relief that many Americans need with a longer lasting dose than its bioequivalent OxyContin.
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 come in.
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