~ Submission to the UK MHRA for review marks critical step towards initiating a Phase 2 Study with CY200 ~
SAN DIEGO, CA / ACCESS Newswire / September 24, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on CRPS (Complex Regional Pain Syndrome), today announced the submission of the protocol for a Phase 2a clinical study of CY200, the Company's newest drug candidate from the newly acquired Cy Biopharma Inc.
This landmark milestone involved the submission of protocol CYBIO_001 entitled "A Phase 2A, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group, Proof of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability of CY200 in Participants with Complex Regional Pain Syndrome Type 1" to the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK where the study will be conducted. CYBIO_001 is designed to evaluate the analgesic efficacy of CY200 compared to placebo in adult participants with CRPS Type 1.
In Complex Regional Pain Syndrome (CRPS), a limb (usually foot and ankle; or hand and wrist) generates continuous pain and becomes increasingly tender, stiff and swollen. The resulting disability often severely impacts work and daily living activities. Additionally, the Central Nervous System (CNS: brain and spinal cord) develops maladaptations, including amplification of pain signals, and distortion of the patient's mental image of the affected limb. Chronic pain and mental health issues often co-exist, and people with CRPS frequently become depressed and anxious as well as developing extreme fear of touch and movement, which can trigger severe pain attacks.
Though CRPS affects a relatively small portion of the population - most often women - its impact can be profound. The condition frequently develops after injury or surgery, with fractures the most common trigger, and trauma or immobilization can further increase risk. Patients often endure a prolonged cycle of treatments with little relief, while every current option is either used off‑label or provides supportive care focused on managing symptoms rather than curing the condition.
Ensysce believes that CY200's neuroplastogenic effects may help by resetting and restoring these abnormalities in the brain, reducing abnormal brain connections and potentially helping the brain to normalize how it processes pain, and also to improve motivation to rehabilitate.
Dr. Richard Langford, Chief Medical Officer of CY, stated, "For people living with Complex Regional Pain Syndrome, the need for a meaningful new treatment could not be more urgent. Our mission is to meet that need by advancing a therapy with the potential to transform how this devastating condition is treated. The MHRA review marks a pivotal step toward initiating our Phase 2a study and bringing CY200 closer to the patients who have waited far too long for a new approach."
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage biotechnology company developing novel neuroplastogenic therapies using psychedelics that go beyond mood disorders and address the root cause of chronic pain through central nervous system modulation. The company is also developing a new class of highly novel opioids for the treatment of severe pain while minimizing the risk of both drug abuse and overdose. For more information, please visit www.ensysce.com.
Forward-Looking Statements
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," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. All forward-looking statements are based upon management's estimates and forecasts and reflect the current views, assumptions, expectations and opinions of the Company as of the date hereof. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expected, including (i) possible Nasdaq delisting; (ii) failure to obtain stockholder approval for the conversion of the Series C non-voting convertible preferred stock into shares of common stock of the combined company; (iii) risks related to the combined company's ability to manage its operating expenses and its expenses associated with the acquisition; (iv) unexpected costs, charges or expenses resulting from the acquisition; (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; (vi) the uncertainties associated with the combined company's product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement and completion of clinical trials, studies and evaluations; (vii) risks related to the inability of the combined company to obtain sufficient additional capital, including the continuation of government funding, to continue to advance these or other product candidates; (viii) failure to achieve the clinical trial milestone for the Milestone Closing; (ix) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (x) risks related to the failure to realize any value from product candidates currently being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. These statements are also subject to risks and uncertainties described in Ensysce's most recent annual report on Form 10-K and quarterly report on Form 10-Q and in other filings that it makes with the U.S. Securities and Exchange Commission (the "SEC"), available 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, except as required under applicable law.
Ensysce Biosciences Company Contact:
Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196
Ensysce Biosciences Investor Relations Contact:
Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us
SOURCE: Ensysce Biosciences Inc.
View the original press release on ACCESS Newswire
