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A Novel Therapeutic to Promote Corneal Repair

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42EY034791-01A1
Agency Tracking Number: R42EY034791
Amount: $380,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NEI
Solicitation Number: PA22-178
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-08-31
Small Business Information
105 SYLVAR ST
Santa Cruz, CA 95060-3728
United States
DUNS: 079613572
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ADAM KRAMER
 (347) 495-9948
 adam@microcures.com
Business Contact
 DAVID SHARP
Phone: (718) 430-3463
Email: david@microcures.com
Research Institution
 ALBERT EINSTEIN COLLEGE OF MEDICINE
 
1300 MORRIS PARK AVENUE
BRONX, NY 10461-1900
United States

 Nonprofit College or University
Abstract

The cornea is one of the most important tissues in the eye and its transparency is critical for good visual function
in humans. Corneal tissue injuries are the most common, everyday issue for practicing ophthalmologists and
can run the gamut in severity. Healing of large corneal wounds, such as alkali burns, involves extended migration
of epithelial cells as well as reinnervation of the cornea. However, complications from injury induced inflammation
slows these processes and worsens outcomes. The inability to seal and reinnervate the corneal epithelium
results in persisting inflammation and increases the risk for corneal ulceration. As strategies for wound care
have evolved, most innovation has continued to focus on minimizing inflammation. These approaches are
important for coaxing cells to migrate and heal the corneal epithelium, but do little for remodeling and repair of
the tissue, resulting in weakly attached tissue and slow healing. Thus, to improve patient outcomes there is a
need for a safe and effective therapy that both expedites migration and reinnervation soon after injury and results
in a more efficiently closed and effectively matured wound. Ideally, mechanisms that deliver factors to
enhance corneal wound healing would be safe, applied topically, remain localized at the site of
application, and provide a rapid but sustained release of the active reagent.
Fidgetin-like 2 (FL2) is a recently discovered regulator of the microtubule cytoskeleton that severs and
depolymerizes microtubules (MT). Down-regulation of FL2 expression enhanced MT function to promote cell
motility in vitro and improved healing both clinically and histologically in murine animal models. MicroCures
aims to develop nanoparticle encapsulated FL2-siRNA (SiFi2) to directly enhance the wound-closure and
healing function of corneal epithelial cells as well as reinnervation thereby offering the potential for
accelerated healing and tissue repair in corneal wounds. Thus, wound healing would reduce scarring and
pain, improve vision, and lower the risk of infection due to faster wound closure, as well as improve restoration
of corneal architecture.
In proof of principle work, the optimal concentration of SiFi2 was determined in a rat model resulting in a shorter
time to re-epithelialization, reduced corneal opacity, and restoration of anatomical corneal structure, with no
evidence of nerve damage or apoptosis. This Fast Track Phase II proposal will initiate steps towards an IND
filing, including defining the formulation to be used. This will be accomplished over four specific aims: (1) develop
a SiFi2 formulation using an ex vivo based assay; (2) evaluate toxicity in a rabbit ocular tolerability model; and
(3) verify efficacy in a rabbit model of corneal burn; and (4) hold a pre-IND meeting with the FDA.

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

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