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Risperidone Subcutaneous Implant

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44MH094036-04
Agency Tracking Number: R44MH094036
Amount: $6,037,027.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 101
Solicitation Number: PA18-573
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-10
Award End Date (Contract End Date): 2021-07-31
Small Business Information
San Francisco, CA 94158-2509
United States
DUNS: 832450394
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (415) 480-6872
Business Contact
Phone: (415) 480-6873
Research Institution

The objective of the proposed study is to develop a subcutaneous implant of risperidone that provides
consistent therapeutic blood levels of the drug for 6 months after a single administration. The device is
implanted during a simple, 10-minute, in-office procedure with local anesthetic. The benefits of the product
include improved medication adherence, fewer relapses, ability to withdraw the medication if needed due to
treatment-emergent Adverse Events (AEs), simple dosing schedule without any initiation required, and a
smooth pharmacokinetic (PK) profile for improved safety and efficacy. Atypical antipsychotics have been used
for years with great results for the treatment of schizophrenia. However, the effectiveness of these agents in
maintenance treatment is limited due to poor medication adherence, which accounts for ~40% of all relapses
and re-hospitalizations. With each successive relapse, the patientandapos;s long-term prognosis deteriorates and
previous level of functioning is rarely achieved. The overall U.S. 2013 schizophrenia cost was estimated at
$155 billion, so non-adherence places a tremendous burden on the healthcare system.
The clinical benefits of long-acting injectable (LAI) formulations have already been proven, and LAIs are
associated with fewer relapses. However, most LAIs only last for a few weeks, with the longest acting
risperidone LAI lasting only 1-month. Although a longer duration would provide additional benefit, two critical
barriers have impeded such development: (1) Safety issues since the drug cannot be withdrawn after
administration, and (2) technical limits of LAI technologies to provide consistent blood levels for more than a
few weeks due to declining PK. Delpor’s implant technology is designed to address these problems and
achieve therapeutic coverage for 6 months. Although some implant technologies already exist, none of them
are suitable for the delivery of risperidone. Results of recent studies show that 86% of physicians and 50% of
patients support the use of implants in this disease area. Delpor has received Phase I and Phase II SBIR
support for this program, which initially targeted a 3-month system. The aims of these programs have been
successfully completed, including all milestones required for the launch of a first-in-man clinical trial. The
company has recently successfully completed a Phase I clinical trial showing flat PK without any serious AEs.
Furthermore, we have been able to extend the product duration from 3 to 6 months. The main objective of this
Phase IIB application is to combine private and public funds in order to complete a pivotal PK Comparability
study and a Summative Human Factors study as requested by the FDA for an NDA submission. We are also
planning to adapt our existing cGMP manufacturing process for commercial production, so we can avoid any
bridging studies after the completion of the pivotal trial. The completion of the pivotal study will bring the
product closer to an NDA submission. Market approval is expected approximately 1-2 years after completion
of the pivotal trial proposed here, after a follow-on safety study has also been completed.PROJECT NARRATIVE
Patient non-adherence in schizophrenia is estimated at 24%-74% of patients and accounts for
approximately 40% of all relapses. Compared to existing schizophrenia treatment alternatives, the
proposed product will reduce relapses during maintenance treatment, improve safety, and increase overall
treatment success. The final outcome will be an improvement in patient lives, and a reduction in overall
healthcare costs.

* Information listed above is at the time of submission. *

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