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Development and optimization of a nitric oxide releasing microparticle-basedtopical treatment for onychomycosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI165204-01A1
Agency Tracking Number: R41AI165204
Amount: $600,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-08-18
Award End Date (Contract End Date): 2024-07-31
Small Business Information
105A Ben Hamby Drive
Greenville, SC 29615
United States
DUNS: 080999429
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (908) 420-4814
Business Contact
Phone: (858) 775-6710
Research Institution
BRONX, NY 10461-1900
United States

 Nonprofit College or University

Onychomycosis is an extremely common and difficult-to-treat fungal nail infection that causes nail disfigurement,
pain, associated infections, and psychosocial effects that negatively impact quality of life. It is caused
predominantly by dermatophytes such as Trichophyton rubrum (T. rubrum) but may also involve yeasts such as
Candida albicans or non-dermatophyte molds. Typical risk factors include trauma, aging, and history of tinea
pedis, but additional comorbidities such as diabetes, obesity, and immune suppression are also significant risk
factors, which are increasing in prevalence. Onychomycosis is typically treated by antifungal drugs administered
topically or systemically, but each approach has significant shortcomings leading to low complete cure rates of
less than 30% and 60%, respectively5,6. Topical antifungals are limited by difficulties in delivering the drug
through the nail plate, which is a highly keratinized, difficult-to-penetrate protective barrier3,4. Systemic
antifungals are generally high cost, may be restricted by limited vascular access to the site of infection, and are
associated with potentially severe adverse effects, including hepatotoxicity. In addition, drug resistance in
onychomycosis may manifest through the development of biofilm growth or through induction of efflux pumps
and mutations. Therefore, the development of an improved treatment for onychomycosis would fill a
significant unmet need and improve the quality of life for those affected by the disease.
The goal of this proposal will be achieved through two interconnected specific aims. In Specific Aim 1, zMPNO
for clinical translation will be synthesized and characterized prior to being evaluated for in vitro antifungal activity
against T. rubrum and other fungal strains relevant to onychomycosis as well as for preliminary cytotoxicity. In
Specific Aim 2, the concentrations of zMPNO in a representative cream vehicle required to deliver sufficient NO
through the nail plate to achieve fungicidal activity will be established. This formulation will then be used to
assess zMPNO efficacy in treating T. rubrum and C. albicans in a RoMar™ ex vivo infected nail model
At the conclusion of this Phase I study, an Optimized Formulation will be established with defined
concentration of zMPNO suitable for further formulation development, scale-up, safety studies, and ex
vivo efficacy studies in Phase II.

* Information listed above is at the time of submission. *

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