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Novel, Self-Applied MicroArray Patch (MAP) of Zanamivir for Treatment of the Flu

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AI179506-01
Agency Tracking Number: R44AI179506
Amount: $299,999.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-176
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-08-01
Award End Date (Contract End Date): 2024-01-31
Small Business Information
540 AVIS DR, STE A
Ann Arbor, MI 48108-7906
United States
DUNS: 156551699
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 ELKE LIPKA
 (734) 223-6862
 elipka@tsrlinc.com
Business Contact
 ELKE LIPKA
Phone: (734) 223-6862
Email: elipka_so@tsrlinc.com
Research Institution
N/A
Abstract

Abstract
Yearly influenza epidemics strike millions of people, causing up to 500,000 deaths. Fatality caused by most
seasonal influenza viruses is lt0.03%, but with significant mortality in the young and the elderly populations.
When a new pathogenic influenza strain enters the population, a pandemic could kill tens of millions of people
with a negative economic impact estimated to be over 150 billion dollars. Due to the incomplete efficacy of the
current vaccines, effective drug treatment is necessary. Presently, influenza treatment is only somewhat
effective, and some influenza strains are resistant to the currently marketed therapeutics, adamantanes and the
neuraminidase inhibitor Tamiflu®. However, while zanamivir (ZAN, Relenza®) remains highly active against
oseltamivir-resistant influenza strains, its therapeutic impact is severely limited by its route of administration, via
oral inhalation, which renders it unsuitable for patients with a compromised respiratory system. Therefore,
development of a novel delivery alternative for ZAN as we propose here, is poised to address a significant unmet
medical need.
Transdermal drug delivery offers a number of improvements over other delivery systems. The drug directly enters
the systemic circulation, circumventing absorption and first-pass barriers typical for oral delivery. It avoids skin
puncture by syringe needles, eliminating pain and patient visits to a clinician. Transdermal delivery of ZAN could
allow large numbers of patients to be reached during an influenza outbreak, which will be particularly important
in light of the added risk during the ongoing COVID-19 pandemic. While ZAN itself cannot cross the human skin
barrier at therapeutic rates, MicroArray Patch (MAP) - enhanced transdermal delivery is an elegant, efficient,
and painless method for increasing the skin permeation of many drugs, including ZAN. Our novel drug-device
combination product, TSR-066, consists of a swellable microneedle array, which will continuously deliver ZAN
from a specially formulated reservoir over 5 days. This Fast-Track SBIR proposal will support optimization of the
MAP with a focus on the applicator component and subsequent manufacturing of supplies for the Phase I clinical
study. We have obtained agreement with the FDA on the preclinical studies needed in order to open the IND, as
well as on the Phase I clinical development plans and the 505(b)2 regulatory strategy. In addition to the
experimental work proposed here, we are developing a robust IP expansion strategy for TSR-066, as well as
future product candidates that stand to benefit from MAP-enabled delivery.
The end result of this work will be a novel, transdermal delivery approach for ZAN, which will expand its reach
into patient groups for which Relenza® is contraindicated and allow for simple administration of ZAN for both
treatment and prevention of the flu. We have assembled a team of expert advisors and collaborators to ensure
successful completion of this research plan.

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

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