Vasoactive intestinal peptide for the treatment of psoriasis

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$372,133.00
Award Year:
2012
Program:
SBIR
Phase:
Phase I
Contract:
1R43AI098137-01
Award Id:
n/a
Agency Tracking Number:
R43AI098137
Solicitation Year:
2012
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-123
Small Business Information
19805 N. Creek Pkwy, Suite 200, Bothell, WA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
167580682
Principal Investigator:
SANDRA REICHSTETTER
(206) 568-1450
sreichstetter@pharmain.com
Business Contact:
CHERRI POE
(206) 568-1450
cpoe@pharmain.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): Psoriasis is a chronic inflammatory skin disease that to this date is only insufficiently controlled by currently available treatments which can also come with severe, and sometimes life threatening side effects. In this application, we propose to create a new class of biologics drug for the treatment of this debilitating disease. We are proposing to formulate the immunomodulatory neuropeptide vasoactive intestinal peptide (VIP) into a long-acting formulation that will be tested as a drug candidate for the treatment of psoriasis. From preliminary experiments we know that our formulation can be injected subcutaneously (s.c.) which is of advantage for patients with severe disease, and we envision that it can be applied topically for less severe cases. During the Phase I of this project, we propose to synthesize a new batch of drug carrier that we used for the formulation of VIP in preliminary experiments. This formulation has increased in vivo half-life and provides better safety properties compared to unformulated VIP. In the proposed project, we will collect data about bioavailability of VIP after s.c. and topical administration, and, as VIP can decrease the arterial blood pressure, measure the blood pressure in the tail of VIP treated mice after topical administration. Blood pressure data already exists for s.c. administration of our VIP formulation. VIP has been shown to be efficacious in many animal models of chronic inflammatory conditions in which efficacy overlapswith efficacy for psoriasis; however, it has not been tested directly in models of psoriasis. We therefore also propose in this application to test efficacy of our long-acting VIP formulation after s.c. administration and topical application in a mouse model of psoriasis. If Phase I is successful, we are planning to conduct a formal toxicity study during Phase II, further develop the topical formulation and file a investigational new drug application with the FDA at the end of Phase II. PUBLIC HEALTH RELEVANCE: Psoriasis is a debilitating chronic inflammatory skin condition with an immense burden on the economy and, despite treatments advances, is still a largely unmet medical need. This proposal would create a new class of biologics drug that can be administered both by subcutaneous injection and for less severe cases by topical application that has the potential of changing the lives of the patients.

* information listed above is at the time of submission.

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