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Preclinical development of a multipurpose intravaginal ring for the prevention of HIV and unintended pregnancy

Award Number: R43AI124815
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: 07/08/2016
PERIOD OF PERFORMANCE END DATE: 06/30/2018

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Preclinical development of a multipurpose intravaginal ring for the prevention of HIV and unintended pregnancy - ¿ DESCRIPTION (provided by applicant): The broad, long-term goal of this research program is to develop a dual protection intravaginal product that will provide contraception and pre-exposure HIV prophylaxis to women in the developing world. Dual protection is a high priority for the NIH, the WHO and for leading NGOs such as the Gates Foundation. NuvaRing(r) is the only intravaginal ring (IVR) approved for contraception. Truvada(r) [tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)] is the only drug approved for pre-exposure prophylaxis. Our strategy is based on delivering the drugs of the NuvaRing(r) in conjunction with the drugs of Truvada(r). In an adaptation of our "pod" IVR platform we will develop independent TDF and FTC "beads" that can be attached to an IVR. Simultaneously we will develop a generic version of the NuvaRing(r) that will be approvable through the ANDA mechanism. Through correspondence with the FDA we have determined the Target Product Profile (TPP) including qualitative and quantitative (Q1Q2) requirements for generic NuvaRing(r)s. We have determined the in vitro release methods and specifications and have manufactured batches of pilot generic NuvaRing(r)s. We have developed pod IVRs delivering TDF-FTC and have demonstrated safety, pharmacokinetics, and efficacy in sheep and primate models. The specific aims of this Phase 1 project will be to select the batch of generic NuvaRing(r)s that match the predicate release, to manufacture a pilot batch of the TDF-FTC pods, and to carry out a pilot safety-PK study to demonstrate feasibility in sheep. In Phase 2 and subsequent work we will confirm bioequivalence of the generic ring to the NuvaRing(r) leading to ANDA approval, and confirm bioequivalence of the contraceptive rings to the rings plus pods. Approval of the pods, although requiring large Phase 3 studies, is none the less feasible. Current competing strategies suffer from serious and potentially fatal scientific and regulatory flaws.


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: 2019 ( Subtotal = $0 )
2019	2016	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Allergy and Infectious Diseases Research	000	1	11/1/2018	NEW	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $219,324 )
2016	2016	AURITEC PHARMACEUTICALS LLC	15 BRAEBURN ROAD	HYDE PARK	MA	02136	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	7/7/2016	NEW	$219,324
														Subtotal = $219,324

Grand Total All Awards = $219,324

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Preclinical development of a multipurpose intravaginal ring for the prevention of HIV and unintended pregnancy

Award Number: R43AI124815

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: 07/08/2016

PERIOD OF PERFORMANCE END DATE: 06/30/2018

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