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Ensysce Exploring Novel Pain Meds

BIOPHARMA: Developing Unique, Safer Opioid Therapeutics

La Jolla clinical-stage biopharma company Ensysce Biosciences (NASDAQ:ENSC) is developing pharmaceutical pathways aimed to provide a safer way to treat pain in patients requiring opioid-level medication while reducing the potential for abuse or overdosage. Newly unveiled clinical data was presented at the U.S. leading pain conference PAINWEEK in Las Vegas this September.

Dr. Lynn Kirkpatrick, PhD 
CEO 
Ensysce Biosciences

An Opioid Epidemic

“We are at a precipice in America where we are now dealing with dueling crises: pain versus drug abuse and overdose,” Ensysce CEO Dr. Lynn Kirkpatrick, PhD shared. “The issue of opioid abuse has led to major problems for some people who live in chronic severe pain and who need an opioid medication. Many have found reduced access to their life-changing medication due to the restrictions that have been put on opioid prescribing.”

According to Ensysce, pain is the leading cause of doctors’ visits, with roughly 35 million Americans suffering from severe pain, resulting in 143 million opioid prescriptions and 10 million people misusing opioid drugs.

“Ensysce is re-engineering opioids, building in features which we believe will make them a safer product to prescribe and with added potential for overdose protection. We hope that our products can provide novel options for both physicians and patients,” added Kirkpatrick.

The Science Behind It

The company is exploring and examining the effectiveness of two core technology platforms – TAAP and MPAR, leveraging both to develop so-called next generation analgesics to target moderate to severe pain.

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The TAAP (Trypsin Activated Abuse Protection) uses chemistry to make a form of a drug of a commonly used opioid, which is inactive until swallowed. The TAAP platform uses one of the body’s own digestive enzymes – trypsin – to trigger the release of the active opioid from an inactive form, meaning it can only be activated in the intestine in the presence of trypsin. This means it’s converted to oxycodone when taken orally as intended, but it cannot be activated if injected intravenously.

“TAAP is a highly novel concept – a chemical modification of an active drug which has a 2-step activation process to release the active drug following exposure to an enzyme that is only found in the small intestine,” she added. “The novelty of TAAP is the limitation of requiring trypsin to start the activation and the second step quick actually controls the rate of release of the opioid.”

Ensysce’s other platform – MPAR (Multi-Pill Abuse Resistance) reduces or turns off the release of the opioid in an overdose situation, providing the additional layer of protection to Ensysce’s TAAP medications. The overdose protection is provided by combining the TAAP form of medication with a small amount of a trypsin inhibitor that reduces or shuts off activation when more than a prescribed dose is taken at one time. The company reports that clinical studies in healthy volunteers showed that this system releases the desired amount of oxycodone when one or two capsules are taken at the same time as it was designed to do, but taking eight capsules at the same time will not result in an overdose.

The lead molecule the company is developing is called PF614 – a form of oxycodone – with a safety profile that’s similar to other traditional opioids but is longer-acting than currently prescribed opioids. The long-lasting effects are especially important for patients battling chronic pain.

Clinical Studies Underway

The company reports that it has tested the product in four clinical studies involving almost 200 subjects. “The specific data points are that we have shown clinically that the [platform] delivers oxycodone safely, with an extended-release profile but the oxycodone from [our drug] lasts longer in the plasma than from other formulated oxycodone extended-release products (OxyContin or Xtampza),” Kirkpatrick shared.

The drug is now poised to enter Phase 3 of its clinical studies. The company will soon meet with the FDA to share its plans. It could be the first FDA-approved product to make opioids safer for patients with chronic severe pain with the promise of eliminating accidental and deliberate overdose with added MPAR protection, Ensysce shared.

Ensysce anticipates commercial launch of the TAAP product by the end of 2025 or early 2026. “The safety signals we observed have been positive in that the side effects are those commonly observed with oxycodone,” Kirkpatrick added.

The company’s current enterprise value is listed at $1.84 million, up from $1.54 million this June but down from $29.25 million in June of last year. Its second quarter reported cash and cash equivalents were $3.8 million in June, compared to $1.4 million in March. Funding under federal grants increased to $500,000 for the second quarter of this year, compared to $200,000 in the comparable year ago quarter.

Ensysce Biosciences

FOUNDED:  2008
CEO:  Dr. Lynn Kirkpatrick, PhD
HEADQUARTERS:  La Jolla
BUSINESS:  Biopharma
STOCK: ENSC (NASDAQ)
REVENUE: Pre-revenue; total assets FY2022 $5,885,052
WEBSITE:  ensysce.com
CONTACT:  info@ensysce.com  (public) or  ENSC@mzgroup.us  (investors)
NOTABLE:  The National Institute on Drug Abuse awarded Ensysce approximately  $12M  to develop  one of its core platforms.

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