Delpor's Investigational Risperidone Implant Product Provides Schizophrenia Therapy for up to One Year after a Single Administration in Phase 1b/2a Patient Study
16 Nov 2023
Clinical ResultClinical Study
Topline results of the Phase 1b/2a study were presented during a poster session at the 2023 Neuroscience Education Institute (NEI) Congress
Delpor's drug/device combination risperidone implant (DLP-114) was well tolerated for up to 12 months
Average PANSS and CGI-I scores were similar between the oral and implant treatment phases of the study
BRISBANE, Calif., Nov. 16, 2023 /PRNewswire/ -- Delpor, Inc. (Delpor), a clinical stage biopharmaceutical company that utilizes innovative technologies to develop once-yearly therapeutics for chronic conditions, today announced topline results of its DLP-114 Phase 1b/2a clinical study during which schizophrenia patients received treatment for up to one year after a single administration. The topline study results were reported for the first time at the 2023 NEI Congress poster session in Colorado Springs on May 10, 2023.
The clinical study (NCT04418466) was an open-label study in stable schizophrenia patients to evaluate the safety, tolerability, and pharmacokinetics (PK) of switching from oral risperidone to risperidone delivered over 6 to 12 months with the risperidone implant. Schizophrenia patients (N=28), stable on a 2-3 mg dose of oral risperidone for at least 2 weeks were randomized to receive either 6- or 12-month DLP-114 implant devices.
No serious adverse events (AEs) attributed to DLP-114 were reported, and DLP-114 was well tolerated for up to 12 months, including the initial placement and follow-up removal procedures. Average PANSS and CGI-I scores were similar between the oral and implant treatment phases. Plasma concentrations of risperidone and 9-hydroxyrisperidone were substantially constant for up to 12 months.
"We are thrilled by the results of our first patient study as it has clearly indicated that DLP-114 has the potential to provide antipsychotic treatment for persons with schizophrenia for up to one year after a single administration. A 6–12-month dosing interval is expected to improve medication adherence which is a major unmet need within mental illness. We are now one step closer to bringing this innovation to schizophrenia patients" said Tassos Nicolaou, Delpor's President and Chief Executive Officer.
"Implantable technology has been successfully developed and accepted in other therapeutic areas, but this treatment option has never been developed for those with a serious psychiatric disorder like schizophrenia. A once- or twice-a-year reversable therapeutic product like DLP-114 will raise the bar for much-needed expansion of new formulation approaches and longer intervals than are available today" said Dr. Peter Weiden, Clinical Professor of Psychiatry at Stony Brook University, who presented the data at NEI.
If approved, Delpor's risperidone implant will be the first once-yearly schizophrenia maintenance therapy. Potential benefits of DLP-114 include reduced relapses due to complete medication adherence for as long as one year, 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. Delpor is planning to conduct future studies to provide higher plasma concentrations and allow for greater dosing flexibility.
About Delpor
Delpor is a clinical stage biopharmaceutical company that utilizes innovative technologies to develop once-yearly therapeutics for chronic conditions. The Company's clinical assets include a 6-12-month formulation of Risperidone for the treatment of schizophrenia, and a 6–12-month formulation of Naltrexone for the treatment of Opioid Use Disorder and alcohol dependence. Delpor is also pursuing 6-12-month formulations of other drugs targeting CNS conditions including 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 dosing of risperidone for schizophrenia maintenance therapy lasting 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.
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SOURCE Delpor, Inc
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