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Long Acting Film Technology for Contraception and HIV Prevention (LATCH)

Award Number: R33AI142687
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/19/2019
PERIOD OF PERFORMANCE END DATE: 01/31/2025

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Long Acting Film Technology for Contraception and HIV Prevention (LATCH) - PROJECT ABSTRACT Several studies (ASPIRE, VOICE) have shown that adherence is paramount to the success of HIV prevention methods in women. Providing women with options through alternative drug delivery technologies can positively impact adherence. A compelling strategy includes co-delivery of an anti-HIV agent with a contraceptive agent to prevent pregnancy. This proposal plans to develop a next generation multipurpose prevention technology (MPT) film platform for once a month intravaginal administration of the 4'-Ethynyl-2-fluoro-2'-deoxyadenosine (EFdA) prodrug (EFdA-P) and a progestin (levonorgestrel (LNG) or etonogestrel (ENG)) to achieve the dual goal of preventing HIV infection and pregnancy. EFdA-P showed increased bioavailability and tissue permeability compared to the parent EFdA, a highly potent exciting new antiviral drug. This versatile extended release MPT film platform is intended to provide a discrete, low cost and convenient alternative to women at high risk of HIV infection and unintended pregnancy. Recent data from our lab shows that films can deliver an anti-HIV agent in the vagina for up to 1 month even in the context of menses and sexual intercourse. Using this knowledge and our expertise in the development of intravaginal films, this proposal will develop a film platform for co-delivery of a progestin (licensed contraceptive agent) and EFdA-P at a predetermined rate for at least 1 month. MPT films containing EFdA will also be generated for comparison. The R61 phase of this milestone driven proposal will generate critical preformulation data for EFdA/EFdA-P and LNG/ENG drug combinations and optimize the MPT film formulation to achieve one- month delivery of both drugs with desired short-term stability. This phase will also establish the compatibility of film prototype with vaginal tissue and microbial flora in vitro followed by vaginal retention studies in the non- human primate (NHP) model. The R61 phase will demonstrate the ability of the MPT film prototype to attain desired release profiles of both drugs in vivo (NHP model). Using a clearly defined go / no go criteria, a lead MPT film will be transitioned to the R33 phase. The R33 phase will involve IND-enabling activities including drug- drug interaction, in vitro transporter and metabolism studies, manufacturing scale up and establishing long-term stability of the lead MPT film. It will also demonstrate the safety (rat, rabbit, and NHP) and efficacy of the lead MPT film against SHIV infection in NHP model. It will also confirm the ability of the film to function in the context of sexual activity and its ability to deliver contraceptive levels of progestin in the NHP model. The successful completion of proposed work will generate a novel extended release MPT film platform that can be applied to other drug combinations.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$222,697 )
2025	2023	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	5	6/6/2025	NON-COMPETING CONTINUATION	-$222,697
														Subtotal = -$222,697

Issue Date FY: 2023 ( Subtotal = $1,443,208 )
2023	2023	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	5	1/19/2023	NON-COMPETING CONTINUATION	$1,069,972
2023	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3240 CRAFT PL STE 100	PITTSBURGH	PA	15213	ALLEGHENY	USA	Allergy and Infectious Diseases Research	001	4	2/3/2023	EXTENSION WITH OR WITHOUT FUNDS	$373,236
														Subtotal = $1,443,208

Issue Date FY: 2022 ( Subtotal = $1,027,086 )
2022	2022	MAGEE-WOMENS RESEARCH INSTITUTE AND FOUNDATION	3339 WARD ST	PITTSBURGH	PA	15213	ALLEGHENY	USA	Allergy and Infectious Diseases Research	000	4	2/25/2022	EXTENSION WITH OR WITHOUT FUNDS	$1,027,086
														Subtotal = $1,027,086

Grand Total All Awards = $2,247,598

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Long Acting Film Technology for Contraception and HIV Prevention (LATCH)

Award Number: R33AI142687

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/19/2019

PERIOD OF PERFORMANCE END DATE: 01/31/2025

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