Ensysce Biosciences, Inc (NASDAQ:ENSC) stock gained almost 100% with a strong session volume compared to the average volume of 81.23K, as per data from Benzinga Pro.

Ensysce Biosciences on Wednesday received a Notice of Allowance from the U.S. Patent and Trademark Office for the issuance of a patent entitled Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof including both composition of matter and method of use claims.

PF9001, the medication covered by this patent, is designed to provide a safer treatment option for opioid use disorder (OUD) by using Ensysce’s TAAP and MPAR abuse-deterrent and overdose protection technologies.

Also Read: Why Is Summit Therapeutics Stock Soaring On Wednesday?

Methadone has long been used for OUD, but concerns over cardiac side effects, respiratory depression, and risk of overdose have limited its use.

Ensysce has developed a new class of agents for OUD in the form of PF9001.

Data demonstrating a reduction in the potential for cardiotoxicity, validating MPAR overdose protection, and indications of potentially delivering a prolonged and predictable effect following once-daily dosing.

The National Institute on Drug Abuse of the National Institutes of Health supported the research covered by this patent.

Ensysce Biosciences completed Part 1 of its second clinical trial in April to evaluate PF614-MPAR for overdose protection.

PF614-MPAR-102 demonstrated that the combined Ensysce TAAP and MPAR technologies can relieve severe pain yet protect from the risk of excessive doses when consumed accidentally or deliberately.

Part 1 of this second study of PF614-MPAR overdose protection confirmed that a 100 mg dosage of PF614-MPAR delivers oxycodone to treat severe pain and provides overdose protection when a greater-than-prescribed dose is consumed.

The data showed that the maximum amount of oxycodone released from PF614-MPAR, when three or more doses were taken at one time (Cmax), was reduced compared to that released following the consumption of the same amount of PF614 alone, evidence of overdose protection.

When five doses of PF614-MPAR were administered, overdose protection was appropriately greater than that observed from three dose units.

Additionally, safety data from the trial showed no unexpected adverse events from either PF614 or PF614-MPAR.

The trial will now continue to enroll Part 2 to examine potential food effects and Part 3 to evaluate repeat dosing of PF614 vs. PF614-MPAR. The aggregate data will allow the company to focus on perfecting a final drug product to move into commercialization.

Ensysce Biosciences announced approximately $1.1 million of registered direct offering in March by issuing 315,188 shares at $3.49 per share.

Price Action: ENSC stock is up 96.30% at $3.67 on Wednesday.

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