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.
For more information visit, 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.
