Delpor Announces First Patient Dosed in Phase 1b/2a Clinical Trial of Once-Yearly Risperidone Implant

If approved, Delpor’s risperidone implant will be the first once-yearly schizophrenia maintenance therapy.

BRISBANE, Calif.–(BUSINESS WIRE)–Delpor, Inc. (Delpor), a clinical stage biopharmaceutical company that utilizes innovative technologies in order to develop once-yearly therapies for chronic conditions, today announced that it has initiated and dosed the first patient in a phase 1b/2a clinical trial of DLP-114, a long-acting formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. This is an open-label study in stable schizophrenia patients to evaluate the safety, tolerability, and pharmacokinetics of switching from oral risperidone to a once-yearly or twice-yearly risperidone implant (DLP-114).

“The dosing of the first patient in our Phase 1b/2a clinical trial is an important milestone for Delpor and our lead asset, DLP-114,” said Tassos Nicolaou, Delpor’s President and Chief Executive Officer. “Medication adherence is a significant challenge for patients with chronic conditions. Using Delpor’s proprietary PROZOR technology, we’ve created DLP-114, a once-yearly, or twice-yearly risperidone implant that has the potential to significantly advance treatment outcomes for individuals with schizophrenia by improving medication adherence, and delivering a “smooth” pharmacokinetic profile resulting in enhanced safety and tolerability.”

This is Delpor’s second clinical trial with DLP-114, as the company has already successfully completed a Phase 1 trial in healthy subjects testing the safety, tolerability, and pharmacokinetics of the product. The Phase 1b/2a, open-label study in stable schizophrenia patients is designed to evaluate the safety, tolerability, and pharmacokinetics of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period. This trial is part of an ongoing research collaboration with the National Institute of Mental Health (NIMH) (www.clinicaltrials.gov, identifier NCT04418466).

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. The company is focusing on CNS drugs. Delpor’s lead program (DLP-114) is a once-yearly formulation of the antipsychotic risperidone for schizophrenia maintenance therapy. 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-114 may be easily removed within minutes if medically required.

About Delpor

Delpor is a clinical stage biopharmaceutical company that utilizes innovative technologies to develop once-yearly therapies 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-114

DLP-114 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 risperidone for schizophrenia maintenance therapy lasting for 6-12 months. Research for DLP-114 is supported by the National Institute Of Mental Health of the National Institutes of Health under Award Number R44MH094036. 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.

Contacts

Delpor, Inc.

Tassos Nicolaou, President and CEO

Phone: 415-480-6873

Fax: 415-480-6871

[email protected]