Summary
The Advanced Research Projects Agency for Health (ARPA-H), through its Proactive Health Office, has announced the “PROactive Solutions for Preserving Resilience” (PROSPR) solicitation. This initiative is designed to extend human healthspan by >20 years. To accomplish this goal, PROSPR seeks to develop innovative approaches that not only predict long-term health outcomes but also integrate preventive interventions that reduce the financial and societal burden of chronic diseases. These approaches will enable transformation of health management as we know it, by shifting the focus from traditional, post-symptomatic treatments to early intervention strategies.
The Foci of PROSPR
The PROSPR solicitation outlines a comprehensive, multi-year program structured around the development, validation, and deployment of novel health technologies. The program is divided into three primary technical areas (TAs), each addressing a critical component of healthspan extension:
- TA1 focuses on developing a PROSPR Intrinsic Capacity (IC) score that quantifies age-associated health changes using both physiological and biochemical metrics. TA1 is composed of two interconnected tracks, TA1a (focusing on IC score development) and TA1b (focusing on evaluation technology). TA1 is further broken down into 5 phases:
- Phase I (12 months) includes IC score development and preparations for a clinical observation study to measure IC score.
- Phase II (12 months) includes refinement of the IC score and assessment technology using data from the clinical observation study.
- Phase III (12 months) includes conducting a lifestyle intervention study to test the mutability of IC score and detection capacity of the IC technology.
- Phase IV (12 months) includes refining the IC score and assessment technology using data from the lifestyle intervention study.
- Phase V (12 months) focuses on deployment and commercialization of the developed IC score and associated technology.
- TA2 aims to repurpose FDA-approved drugs for healthspan extension by identifying key biochemical markers and designing decentralized clinical trials that can validate these interventions in a cost-effective manner. TA2 is broken into two tracks, TA2a (biochemical markers) and TA2b (FDA-approved drugs). TA2 is further broken down into 5 phases:
- Phase 1 (12 months) identification of useful biomarkers and preparation for a phase 3 decentralized clinical trial for drug repurposing.
- Phase II (6 months) finalizing clinical trial study requirements and biomarker reporting.
- Phase III (12 months) conducting the phase 3 decentralized clinical trial.
- Phase IV (12 months) continued data collection and monitoring.
- Phase V (18 months) conclusion of phase 3 trial; FDA engagement for regulatory approval.
- TA3 is dedicated to the evaluation of second-generation interventions, emphasizing rigorous preclinical studies and early-phase clinical trials to assess novel therapeutics designed to enhance overall health and functionality in aging populations.
- Phase I (18 months) preclinical validation of intervention with aged animal models.
- Phase II (18 months) IND-enabling studies to evaluate the safety, pharmacokinetics, and behavior of second-generation interventions.
- Phase III (6 months) establishing IRB approval and preparing for the clinical trial.
- Phase IV (18 months) conducting the first-in-human clinical testing of second-generation interventions to assess safety and efficacy in a Phase 1b clinical trial.
Key Proposal Dates
- Solution Summary Due Date: April 25, 2025, at 2:00 PM ET
- Estimated Full Proposal Due Date for invited Proposers: May 23, 2025, at 5:00 PM ET.
Additional Information
This opportunity anticipates the negotiation of multiple Other Transaction Agreements. While the precise award sizes and timelines will be determined during the negotiation phase, successful proposals can expect to receive funding that supports a comprehensive research and development effort over a Period of Performance up to 5 years.