Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, Discusses the Recent Breakthrough Therapy Designation for PF614-MPAR

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In an interview with Pharm Exec associate editor Don Tracy, Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, discusses the FDA's Breakthrough Therapy Designation for PF614-MPAR, which focuses on protecting patients from drug overdoses.

Pharm Exec: Recently, Ensysce Biosciences was granted Breakthrough Therapy Designation for PF614-MPAR. Can you explain what this means for the future of protecting patients from drug overdoses?

Kirkpatrick: We're certainly elated with the Breakthrough Therapy designation, especially for a novel opioid product. This breakthrough therapy will now allow us to interact more directly with the FDA and get the product on the market as quickly as possible. I'm sure you're aware of the statistics. We lose somebody every 30 minutes, two a day, 17,000 people a year to prescription opioid overdose. This tragedy obviously means overdose protection for a prescription drug is really innovative. No other abuse deterrent product that's currently on the market has this type of property. Our product is designed to turn off the release of opioids if somebody intentionally or by accident swallows too many pills. We're very delighted that the agencies recognizes the unique aspect of the product.

Pharm Exec: Can you explain in more detail how the treatment works?

Kirkpatrick: As I mentioned, PF614-MPAR is an opioid that delivers pain relief. If it's taken simultaneously in large doses, it will turn off the release of the opioid. We've demonstrated this clinically, and it really stems from the chemistry we designed into PF614. It's not a formulation, it's a chemically modified opioid which has to be swallowed an exposed to an enzyme in our small intestine that we call trypsin. The chemistry provides the abuse protection because we don't have trypsin in any other parts of our body and that removes someone's ability to chew to make it work faster, to inhale it, snort it, or crush and inject it. You effectively have to swallow it. What PF614 doesn't do is remove that opioid overdose potential. MPAR is the real key to providing overdoes protection. This is when we combine PF614 with a trypsin inhibitor. It sounds a little counterintuitive but the trypsin inhibitor in very small doses doesn't effect the release. So you get your pain relief when you take your prescribed dose. If you've forgotten or if you intentionally take too much to get high, you're taking more trypsin inhibitors. So, it's blocking that first enzymatic cleavage of the chemistry. The material passes out of the body unchanged and the overdose is averted. We've shown this clinically and that's the data we shared with the FDA to show it actually works. Being a medicinal chemist, and the chemistry for modifying PF614 to reduce abuse as well as combining it with a trypsin inhibitor to prevent overdose is exquisite.

Pharm Exec: How can this product help address the issue of patient access to analgesics for severe pain?

Kirkpatrick: We currently have two co-existing crises. We have those people waking up every day in severe pain that are now having trouble accessing their pain medication because there are people abusing opioids. The abuse of the product has really restricted the people who really need the medication from getting it. Opioids have been used for thousands of years. We believe a safer product on the market should and may turn the tide for regulations.

What we intend to do with PF614-MPAR is try to get this broadly available as quickly as possible. We'll work with managed care and price it in the region where products are priced today. We believe those who need opioids may have more comfort in the fact that there will be a safer product on the market.

Pharm Exec: Your website speaks about Ensysce’s MPAR technology. Can you briefly explain that and the TAAP medication that goes with it?

Kirkpatrick: TAAP is trypsin activated boost protection. That is the chemistry we have used to modify the opioids and we've modified oxycodone. As I said, it's designed to really release an opioid with the exact same profile as oxycodone products and we certainly have heard a lot about it. We believe PF614 really replaced it on the market as being a safer bet based on our chemical approach versus the formulation approach of the products that are called abuse deterrent formulations. The chemistry used to modify the opioid is also what we designed MPAR with because we can block that activation with the trypsin inhibitor. We use chemistry to modify the release of the opioid and then combine that with the trypsin inhibitor and our MPAR technology to give us overdose protection. Not only do we make a safe opioid, which is less abusable, but we can also add that overdose protection.

Pharm Exec: Are there any other treatments in your pipeline that you wish to highlight?

Kirkpatrick: I've talked about chemically modifying opioids. We've demonstrated the fact that we can do that with oxycodone. We also have three other opioids that we've designed using our TAAP technology and we've designed them to be be both extended as well as immediate release products. We can combine all of these with a trypsin inhibitor and MPAR so all of these have overdose protection as well. Additionally, we've used this real platform technology and applied it to ADHD products which we know are abused and that's another area of interest that we have. We've also initiated a collaboration with a company developing another pain product entirely different from opioids to treat oral mucositis in patients with cancer, people who are undergoing radiation or chemotherapy, and alterations in the mouth. This product is being evaluated in Europe and we've become the American arm of the company developing it. We are working with them to try and get it on the market here to help people with cancer alleviate their pain as well.

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