Ensysce Biosciences' Mission to Combat Prescription Drug Overdose and Abuse
By: Vera Kovacevic, PhD
Interviewee: Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences
Ensysce Biosciences' Mission to Combat Prescription Drug Overdose and Abuse
By: Vera Kovacevic, PhD
Interviewee: Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences
The alarming statistics on prescription drug abuse and overdose in the US underscore the significance of Ensysce Biosciences’ mission.
The mission to provide safer pain medications is more critical than ever. Ensysce Biosciences, led by Dr. Lynn Kirkpatrick, an expert medicinal chemist and its current CEO, is facing this quest. Xtalks spoke with Dr. Kirkpatrick about Ensysce Biosciences’ innovation in the battle against prescription drug abuse and overdose.
Ensysce Biosciences has a pioneering two-step trypsin activation technology, designed to revolutionize drug delivery across a broad spectrum of medications. This unique approach, involving TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance), ensures that medications are activated only in the small intestine and are resistant to abuse when taken excessively. These technologies have garnered significant recognition, including Fast Track designation for TAAP™ and Breakthrough Therapy designation for MPAR® from the US Food and Drug Administration (FDA), accelerating their potential path to commercialization.
According to the Centers for Disease Control and Prevention (CDC), in 2021, opioids were implicated in 80,411 overdose fatalities, accounting for 75.4 percent of all drug overdose deaths. This public health crisis highlights the urgent need for safer pharmaceutical innovations like those under development by Ensysce Biosciences.
A Vision of Safer Medications
Dr. Kirkpatrick begins by outlining the vision that drives Ensysce Biosciences. “Our vision is to provide the most effective drugs with exquisite safety for a number of indications,” she explains. The company's primary focus is on opioids, a class of drugs where abuse and overdose present significant unmet needs.
Unlike other companies that have traditionally relied on physical barriers in drug formulations to deter abuse, Ensysce Biosciences employs a unique chemical approach. TAAP™ alters the delivery of the drugs to enhance safety and limit abuse methods, while MPAR® adds another layer of overdose protection to TAAP products. This approach, she notes, can provide a more formidable barrier against abuse compared to conventional methods like hard candy shells or gooey gels that have proven ineffective.
Overcoming Challenges with Clever Chemistry
When asked about the biggest challenges the company faces, Dr. Kirkpatrick highlights the complexities of developing drugs in an environment overshadowed by the opioid crisis and resulting regulatory and societal scrutiny.
“We’ve chosen to apply our technology, our clever chemistry, to opioids because of its significant unmet needs,” she states. Despite the obstacles, the company has pressed forward, demonstrating the safety and effectiveness of its products in clinical settings. Their efforts culminated recently in a Breakthrough Therapy designation for their lead product, an indication of their innovative approach to overdose protection.
Strategic collaborations have been vital to Ensysce Biosciences’ development process. Dr. Kirkpatrick emphasizes the importance of partnerships with various external groups that augment her team's expertise. “We’re a very small team, so we have partners in manufacturing, clinical, regulatory, even financial aspects of the company,” she says. These partnerships have been essential in advancing their R&D goals efficiently.
“Our vision is to provide the most effective drugs with exquisite safety for a number of indications. Our first focus has been opioids because of the significant unmet needs, both with the abuse problems and the overdose problems. Our approach is entirely different than anybody else has taken."
— Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences
“Our vision is to provide the most effective drugs with exquisite safety for a number of indications. Our first focus has been opioids because of the significant unmet needs, both with the abuse problems and the overdose problems. Our approach is entirely different than anybody else has taken."
— Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences
Looking to the Future
Looking ahead, Dr. Kirkpatrick is optimistic about the company's direction over the next decade. “Primarily, our goal is to get our lead product, PF614, a TAAP™ modified oxycodone product, into the hands of those who require strong analgesia with the safety of TAAP™,” she shares. This product may redefine the treatment of severe pain by integrating abuse resistance without compromising effectiveness.
Dr. Kirkpatrick also detailed the broader applications of Ensysce Biosciences’ proprietary platforms: “TAAP™ and MPAR® are platform chemistries that we can apply to many other therapeutics. We've already done that in the field for ADHD, and we're looking at opportunities for gut delivery.” This expansion into other therapeutic areas signifies Ensysce Biosciences’ ambition to leverage its innovative technology across a wider spectrum of medical needs.
A Personal Journey into Leadership
Reflecting on her journey, Dr. Kirkpatrick’s passion for medicinal chemistry and drug development shines through. From her academic tenure in Canada to founding her first company and eventually joining Ensysce Biosciences, her career has been driven by a commitment to innovation in drug delivery and development.
"I taught students chemistry, we had a great research lab, and in that lab, I developed some products that, at that time, I thought in order to get them into the hands of people that might be able to develop them, we had to start a company," Dr. Kirkpatrick recalls about her decision to move from academia to industry.
“I moved from a small private company doing the R&D development into now forging in the public arena and trying to get these drugs from development to launch,” she recounts. Her transition from the bench to the CEO’s office embodies her goal to bring safer, effective treatments to market.
In the conversation, Dr. Kirkpatrick not only shared Ensysce Biosciences' innovative approaches to addressing critical public health issues but also illuminated the personal conviction and scientific rigor that guide her leadership.
Her vision for a future where pain management is both effective and safe sets a strong example for the pharmaceutical industry, emphasizing the substantial impact that thoughtful, science-driven innovation can have on society.
ABOUT Dr. Lynn Kirkpatrick
As CEO of Ensysce Biosciences, Lynn Kirkpatrick, PhD oversees the company’s development of first-in-class and uniquely innovative solutions in oral drug delivery. She has a background in medicinal chemistry and pharmacology, drug discovery and development. She previously co-founded two start-up companies and is credited with the development of three, targeted small molecule oncology drugs from discovery to clinic.