Delpor Announces First Subjects Dosed in Phase 1 Clinical Trial of Once or Twice-Yearly Naltrexone Implant for Opioid Addiction

BRISBANE, Calif.--(BUSINESS WIRE)-- Delpor, Inc. (Delpor), a clinical stage biopharmaceutical company that utilizes innovative technologies to develop once-yearly therapeutics for chronic conditions, today announced that it has initiated and dosed the first subjects in a phase 1 clinical trial of DLP-160, a 6-12-month formulation of naltrexone for the treatment of opioid use disorder (OUD). This is an open-label study in healthy volunteers to evaluate the safety, tolerability, and pharmacokinetics of naltrexone when administered in sequence of Naltrexone HCL (Oral), DLP-160 (Naltrexone Implant), followed by Vivitrol® (Intramuscular).

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DLP-160 (6-12 month Naltrexone Implant) uses Delpor’s proprietary PROZOR technology platform enabling sustained release of drugs from a small, matchstick-long implantable drug delivery device. The device is placed just under the skin in the abdomen during a simple, 10-minute in-office procedure and delivers therapeutic levels of drug for as long as one year. Potential benefits include reduced relapses due to complete medication adherence after a single administration, and steady drug release without the adverse event inducing peaks or sub-therapeutic troughs. Unlike long-acting injectable formulations, which are not reversible, DLP-160 may be easily removed within minutes if opioid administration is required (e.g. due to injury or surgery).

“The dosing of the first subjects in this Phase 1 clinical trial is an important milestone for Delpor as another one of our pipeline assets, DLP-160, has now advanced to the clinic,” said Tassos Nicolaou, Delpor’s President and Chief Executive Officer. “Using Delpor’s proprietary PROZOR technology, we’ve developed a naltrexone implant that has the potential to significantly advance treatment outcomes by ensuring medication adherence for 6 or 12 months.”

This is Delpor’s second product to reach the clinical development milestone behind its lead asset, DLP-114, a once-yearly risperidone implant for the treatment of schizophrenia which is currently in phase 1b/2a. The CDC states that overdoses are the leading injury-related cause of death in the United States and appear to have accelerated during the COVID-19 pandemic. Naltrexone is one of the three FDA-approved medications used to treat OUD, but its effectiveness can be limited by difficulties with medication adherence. The longest acting naltrexone formulation currently available is once-monthly. “We recognize that after detoxification, OUD patients have a very challenging journey ahead of them as they try to reintegrate into their communities. Our goal is to make it easier for them to avoid relapses by removing medication adherence from the treatment equation,” Mr. Nicolaou continued.

According to the Centers for Disease Control and Prevention’s Drug Overdose “Get the Facts” website, in 2020, nearly 92,000 people died from drug overdoses, a 31% increase from the approximately 71,000 overdose deaths in 2019. 75% of the 2020 overdose deaths involved a prescription or illicit opioid. In 2020, an estimated 41.1 million Americans needed substance use disorder treatment, only 2.6 million received treatment.

Delpor’s PROZOR technology enables the sustained release of drugs from a non-mechanical, matchstick-long, implantable drug delivery device based on a unique formulation. The device is implanted in the abdomen during a simple, 10-minute in-office procedure, and delivers therapeutic levels of the drug for as long as one year. Potential benefits include reduced relapses due to complete medication adherence for as long as one year after a single administration, and steady drug release without any adverse event inducing peaks, or sub-therapeutic troughs. Unlike long-acting injectable formulations, which are not reversible, DLP-160 may be easily removed within minutes if opioid administration is required (e.g., due to injury or surgery)

About Delpor

Delpor is a clinical stage biopharmaceutical company that utilizes innovative technologies to develop once-yearly therapeutics for chronic conditions. The Company’s lead product is a 6-12-month formulation of Risperidone for the treatment of schizophrenia. Delpor is also pursuing 6-12-month formulations of other drugs targeting CNS conditions including schizophrenia, addiction, spasticity, Parkinson’s, Alzheimer’s, and other conditions. Additional information can be found at www.delpor.com

About DLP-160

DLP-160 is an investigational therapy that employs Delpor’s proprietary technology platform. It utilizes a matchstick-long implant device, that is placed sub-dermally to provide continuous and consistent drug therapy of naltrexone lasting for 6-12 months for the treatment of opioid use disorder. Research for DLP-160 is supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number 5UG3DA050306. The content of this release is solely the responsibility of Delpor and does not necessarily represent the official views of the National Institutes of Health.

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment and other risks the Company may identify from time to time in the future.

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