Microneedle Delivery of Zanamivir for Treatment of Influenza Infections

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI129122-01A1
Agency Tracking Number: R43AI129122
Amount: $287,765.00
Phase: Phase I
Program: SBIR
Awards Year: 2017
Solicitation Year: 2016
Solicitation Topic Code: NIAID
Solicitation Number: PA16-302
Small Business Information
540 AVIS DR STE A, Ann Arbor, MI, 48108-7906
DUNS: 156551699
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 ELKE LIPKA
 (734) 223-6862
 elipka@tsrlinc.com
Business Contact
 ELKE LIPKA
Phone: (734) 663-4233
Email: elipka@tsrlinc.com
Research Institution
N/A
Abstract
Abstract Yearly influenza epidemics strike millions of people causing up to deaths Fatality caused by most seasonal influenza viruses is andlt 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 billion dollars Influenza virus is a NIAID category C priority biothreat characterized as an emerging agent that is readily available and disseminated 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 zanamivir Relenza remains highly active against oseltamivir resistant influenza strains but 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 zanamivir as we propose here is poised to address a significant unmet medical need Application of a transdermal microneedle delivery strategy to the anti viral and particularly anti influenza market offers a number of solutions to large unmet medical needs and represents an attractive market entry strategy Transdermal delivery systems offer a number of improvements over other delivery systems Patches do not require swallowing eliminating oral side effects Permeation through the skin allows the drug to directly enter the systemic circulation and avoid any absorption and first pass barriers a drug might encounter with oral delivery Finally transdermal delivery avoids skin puncture by syringe needles eliminating pain and patient visits to a physician Transdermal delivery of ZAN is desirable during an influenza outbreak as large numbers of patients can be reached The Phase I portion of this proposal will involve formulation optimization of the prototype patch and subsequent pharmacokinetic and efficacy testing in mice The final study for this proposal will be a dermatotoxicology studies to assess skin irritation of the final patches in rabbits The end result of this work will be a novel transdermal delivery approach for zanamivir with demonstrated efficacy PK and initial preclinical safety data ready to complete preclinical development activities leading to the opening of an IND We have assembled a team of expert advisors and collaborators to ensure successful completion of this research plan Project Narrative TSRL and its collaborator F Pharma is developing a novel transdermal delivery product of zanamivir for the treatment if the flu The proposed research will establish the proof of concept that effective treatment of the flu can be achieved with a patch Completion of the work in this proposal would render the candidate ready for full preclinical development

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

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