Ensysce Biosciences Discusses TAAP and MPAR® Applications and OncoZenge Partnership with The Stock Day Podcast
The Stock Day Podcast welcomed Ensysce Biosciences (Nasdaq:ENSC)(“the Company”), a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. CEO of the Company, Dr. Lynn Kirkpatrick, joined Stock Day host Matthew Dunehoo.
Dunehoo began the interview by asking about the Company’s background and current projects. “Ensysce Biosciences is a clinical stage company using two highly novel technology platforms, TAAP and MPAR®, while applying these to known therapies to improve both drug safety and drug performance,” explained Dr. Kirkpatrick. “We have applied TAAP and MPAR® to a number of different drug classes but we are focused initially on the opioid-classic medications, in order to stem the crisis that as we know has resulted in thousands of deaths over the last decade.”
“By using known therapies, we believe we can develop new drugs more quickly and at reduced costs, while expanding our product pipeline across many indications,” continued Dr. Kirkpatrick. “We have developed our lead product, PF614, which is an oxycodone TAAP-pro drug and all of our clinical trials have shown that it works exactly how it is designed,” she explained, adding that the drug features an extended release design and has been proven pain relief for a 12-hour period.
“We chemically modify a drug, in this case oxycodone, to make it inactive unless swallowed,” said Dr. Kirkpatrick. “It uses the body’s own digestive enzyme to start an activation process releasing oxycodone for absorption and pain relief,” she said. “When the drug is inactive unless swallowed, it removes the ability to administer the drug through inhalation, snorting, or injection to remove those pieces of abuse potential,” said Dr. Kirkpatrick. “It also gives us a true twice a day product.”
“With MPAR®, Multi-Pill Abuse Resistance, this takes the protection one step further,” continued Dr. Kirkpatrick, noting that the drug features a digestive enzyme prohibitor. “It blocks the digestive enzyme that is used to release the drug when you have taken too much, and it only kicks in when you take more than the prescribed dose.”
“We believe TAAP and MPAR® make opioids safer,” said Dr. Kirkpatrick. “The beauty of these platforms are that they can be applied to other medications that may have a safety or delivery issue,” she said. “It gives us many opportunities in our development platform.”
“When do you anticipate Phase III trials and ultimately the potential commercialization for PF614?”, asked Dunehoo. “Over the last 18 months we have been working diligently to complete all of the work we need to get to Phase III,” said Dr. Kirkpatrick. “We are poised for Phase III and we have a meeting scheduled with the FDA in January to discuss our plans, which is called an end of Phase II meeting,” she explained. “We believe we are on track with our plans to start conducting Phase III trials in 2024, while still filing our NDA in late 2025, and commercialize at that point after review.”
The conversation then turned to the Company’s strategic partnership with OncoZenge. “We are very excited about this new opportunity,” said Dr. Kirkpatrick. “It adds another product to our pipeline to treat pain,” she shared. “BupiZenge™, the product that we are working on with OncoZenge, gives us another tool to treat pain outside of the opioid class,” said Dr. Kirkpatrick. “It is for cancer patients with a debilitating complication called oral mucositis.”
To close the interview, Dr. Kirkpatrick elaborated on the Company’s knowledgeable and experienced team of industry-leading experts, and encouraged listeners and shareholders to keep up-to-date on the Company’s current and upcoming projects as they continue to expand their pipeline.
To hear Dr. Lynn Kirkpatrick’s entire interview, follow the link to the podcast here:
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 (TAAP) 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.
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
Ensysce Biosciences Investor Relations Contact:
MZ North America
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