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Preclinical development of an intravaginal ring for the sustained release of Pritelivir for the treatment and prophylaxis of Genital Herpes in women

Award Number: R43AI136201
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: 02/01/2018
PERIOD OF PERFORMANCE END DATE: 04/03/2019

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Preclinical development of an intravaginal ring for the sustained release of Pritelivir for the treatment and prophylaxis of Genital Herpes in women - SUMMARY The broad, long-term goal of this project is to develop a pritelivir intravaginal ring (IVR) for the treatment and pre-exposure prophylaxis of genital herpes, a common problem that affects more than 50 million Americans. Recurrences are common and may be painful. Infection is life-long. Pritelivir is a promising α-helicase inhibitor that proved superior to existing therapies in Phase 2 clinical trials, but whose clinical development as a systemic therapy has been arrested because of toxicity. Local therapy is therefore, of special interest. We have developed a platform technology for the sustained release of antivirals. This technology led to the FDA approval of a ganciclovir-based intraocular implant - Vitrasert®, for the treatment of AIDS-related cytomegalovirus retinitis. We have adapted this platform to IVRs and have successfully delivered other antiviral agents at therapeutic levels in preclinical and clinical trials. We propose to utilize this platform to develop sustained release vaginal ring formulations for pritelivir. In this Phase I proposal, we will formulate pritelivir IVRs, test the formulations for in vitro release and perform safety and pharmacokinetic studies in an animal model, Successful completion of this work will lead to IND enabling studies in Phase II, and clinical trials in Phase IIB SBIR proposals. The team of investigators is expert in drug development, synthetic chemistry, pharmacokinetics, and clinical infectious disease. We have experience in collaboration with large pharmaceutical companies leading to the approval of novel drug delivery systems. This project could lead rapidly to the development of an improved treatment for genital herpes.


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: 2020 ( Subtotal = $0 )
2020	2018	AURITEC PHARMACEUTICALS, INC.	2285 E FOOTHILL BLVD	PASADENA	CA	91107	LOS ANGELES	USA	Allergy and Infectious Diseases Research	000	1	10/28/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $26,706 )
2019	2018	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Allergy and Infectious Diseases Research	001	1	6/28/2019	NEW	$26,706
2019	2018	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Allergy and Infectious Diseases Research	000	1	3/28/2019	NEW	$0
														Subtotal = $26,706

Issue Date FY: 2018 ( Subtotal = $224,484 )
2018	2018	AURITEC PHARMACEUTICALS INC	3200 SANTA MONICA BLVD STE 201	SANTA MONICA	CA	90404	LOS ANGELES	USA	Allergy and Infectious Diseases Research	000	1	1/25/2018	NEW	$224,484
														Subtotal = $224,484

Grand Total All Awards = $251,190

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Preclinical development of an intravaginal ring for the sustained release of Pritelivir for the treatment and prophylaxis of Genital Herpes in women

Award Number: R43AI136201

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: 02/01/2018

PERIOD OF PERFORMANCE END DATE: 04/03/2019

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