ENSC: Ensysce Continues to Progress in Fight Against Opioids
NASDAQ:ENSC
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Ensysce Biosciences (NASDAQ:ENSC) continues to make progress toward their goal of helping attack the crippling opioid crisis currently facing humanity. Their TAAP technology continues to move along the FDA pipeline toward the ultimate goal of getting potentially life-saving products into the market. We continue to be encouraged by the actions of management at Ensysce and believe investors with a higher risk tolerance looking for a potentially game-changing investment that also has the added benefit of providing a solution to one of the great social problems facing society today should take a look at Ensysce. The investment case continues to be bolstered in our view and we wanted to give some updates on the company’s progress:
• December 2021—The company announced that it had enrolled the first patients in the Phase I study of MPAR, which is designed to reduce opioid overdose. The company’s Chief Medical Officer, Dr. William Schmidt, said, “The clinical data coming from this trial will guide our MPAR drug product development. We intend to use the data to provide the building blocks to design a second trial at the end of 2022 to fully demonstrate the lifesaving overdose protection of our MPAR technology.”
• January 2022—Ensysce announced that it had successfully completed Part A of the previously announced study. This part of the trial evaluated three dose levels of PF614, the company’s drug abuse resistance program described in detail below, while other participants received OxyContin at comparable dose levels. The safety study was deemed successful, with full results expected in the first quarter of 2022, and allows Ensysce to continue to the second phase of the 2-part study, a bioequivalence study, the results of which are expected by the end of the second quarter of 2022.
• January 2022—the first dosing in bioequivalence study of PF614 compared to OxyContin was announced.
• February 2022—announced the appointment of Lee Rauch to Ensysce’s Board of Directors. We view this as a positive addition, with Ms. Rauch bringing company building experience combined with merger and acquisition and financing qualifications to the company.
These developments, in our view, continue to support the case for investing in Ensysce Biosciences and further supports our enthusiasm for a company pursuing a technology meant to tackle the scourge of opioid addiction. We are anxiously awaiting results from the ongoing trials described and, at this point, are expecting those results to reveal more positive results—further building the investment case for Ensysce.
The technology under the TAAP platform mentioned above is designed to release effective opioid drugs only when exposed to specific physiological conditions—in this case specifically when the drug is ingested and exposed to the digestive enzyme trypsin. The company’s proprietary technology prevents abuse through a two-step internal trypsin-activation process. Their prodrugs are chemically stable molecules that are activated only when administered orally. Due to the activating enzyme of trypsin not being present in blood or saliva, the drug cannot be activated through injection, chewing or snorting. This is in contrast to many other opioid products marketed having, or in late-stage clinical development for, “abuse-resistance”. These products often use extended-release formulations, which are still prone to abuse by crushing, chewing or extracting and injecting the drug for an immediate release of active opioid to achieve a rapid euphoric rush.
Ensysce claims that TAAP and MPAR limit all forms of drug abuse and is adaptable to most prescription drugs having the potential for abuse—potentially extending the market beyond opioids. To this point, trials have supported these claims and we believe the market for such a product would be enormous, given the propensity of opioid addiction around the world.
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