Therapeutic D-peptide Inhibitor of HIV entry

Award Information
Agency:
Department of Health and Human Services
Amount:
$299,392.00
Program:
SBIR
Contract:
1R43AI095172-01A1
Solitcitation Year:
2011
Solicitation Number:
PA10-050
Branch:
N/A
Award Year:
2011
Phase:
Phase I
Agency Tracking Number:
R43AI095172
Solicitation Topic Code:
NIAID
Small Business Information
NAVIGEN, INC.
383 Colorow Drive, SALT LAKE CITY, UT, -
Hubzone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Duns:
792046224
Principal Investigator
 ALAN MUELLER
 (801) 587-1426
 amueller@navigenpharma.com
Business Contact
 BRANDI SIMPSON
Phone: (801) 990-2498
Email: brandisimpson@navigenpharma.com
Research Institution
 Stub
Abstract
DESCRIPTION (provided by applicant): HIV/AIDS remains a formidable global epidemic with 33 million infections worldwide, including over 1 million patients in the US. In 2008, there were 2.7 million new infections and 2 million AIDS-related deaths. CurrentHIV treatment combines drugs from several classes of HIV inhibitors and has dramatically extended the lives of many HIV patients, but serious side effects and rapidly increasing drug resistance are significant concerns. Thus, there is a continuing need todevelop HIV inhibitors with new mechanisms of action and more robust resistance profiles. Navigen Pharmaceuticals is a pharmaceutical development company targeting infectious diseases. Using a combination of discovery and design, we have identified a novel type of HIV entry inhibitor (protease-resistant D-peptide) that targets HIV's conserved extracellular entry machinery and overcomes the limitations of existing HIV entry inhibitors (e.g., frequent and high dosing, narrow breadth, injection site reactions, and susceptibility to resistance). Our lead prototype (PIE12-trimer) potently inhibits diverse strains from all major subtypes of HIV and is extraordinarily elusive to resistance. We have developed multiple variants of PIE12-trimer in an effort to minimize dosing frequency and have selected two that we expect to be superior. In this one-year grant application, Navigen proposes to (1) develop a bioanalytical assay to support preclinical development of PIE12-trimer, (2) measure pharmacokinetic (PK) properties, and (3) conduct acute, 7-day, and 28-day rat toxicity studies on the two most promising lead candidates. This information will allow Navigen to select an ideal PIE12-trimer variant with low toxicity and PK properties compatible with weekly dosing for advancement into IND-enabling studies and ultimately clinical trials. PUBLIC HEALTH RELEVANCE: Navigen Pharmaceuticals is developing a potent and novel inhibitor of HIV entry. The goal of this study is to optimize our lead candidate for weekly dosingand low toxicity. If successful, this new inhibitor will improve the health of HIV/AIDS patients by providing them with a safe and highly effective new therapeutic option.

* information listed above is at the time of submission.

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