LEAP Extended for 5 Years


Long-Acting/Extended Release Antiretroviral Research Resource Program to add therapy development for tuberculosis and viral hepatitis

July 28, 2020—The Long-Acting/Extended Release Antiretroviral Research Resource Program (LEAP) today announced approval of a new NIH grant that allows for expansion of its charter to promote development of medications that are more manageable for patients. Going forward LEAP will include tuberculosis and viral hepatitis, which are comorbidities that complicate HIV treatment.

Established in 2015, LEAP is a resource for investigators from around the world working to develop long-acting/extended release HIV therapies. The program identifies promising drug formulations and injectable, transdermal, and implantable delivery devices that eliminate burdensome daily pill regimens that often lead to nonadherence among patients. In addition to guidance from experts from government, academia, and industry, the program offers Modelling and Simulation Core services that identify the most promising drug and formulation candidates, thereby helping investigators tailor their LA/ER research and development efforts.

LEAP was highly productive during its first phase. The program provided foundational input for FDA draft guidance on the development of LA/ER formulations for HIV; promoted development of the first candidate LA/ER formulations for tuberculosis and malaria; organized the first conference on the use of LA/ER formulations for HIV in children, adolescents, and pregnant women; developed the first publicly accessible website devoted to LA/ER anti-infective products and strategies; and supported development of novel devices like anti-HIV implants and microneedles through its Modelling and Simulation Core.

 “Our expanded charter to include common HIV comorbidities in therapy development guidance leverages the progress we’ve achieved to date,” according to LEAP Principal Investigator and Johns Hopkins Professor of Pharmacology and Molecular Sciences Dr. Charles Flexner. “The ultimate goal of LEAP is to inform and help expedite development of products that are safe and effective, and that take human error and nonadherence off the table for patients. We recognized a critical need to target HIV comorbidities and are thrilled at the opportunity to do so.”

In addition to expanding the disease targets, the new grant will allow the program to prioritize future drugs and delivery platforms and develop next generation predictive strategies to more rapidly identify the most promising drugs and devices.

LEAP is supported through an R24 grant by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. The grant was funded at $3.48 million, and the project will run through June 2025.