GAITHERSBURG, Md., April 16, 2012 /PRNewswire-iReach/ -- DFH Pharma, Inc., (DFH) a privately held specialty pharmaceutical company focused exclusively on developing HIV-1 therapeutics, today announced that it will collaborate with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the United States National Institutes of Health (NIH), to develop 2nd generation HIV maturation inhibitor drugs. DFH will work with the NIAID's Division of AIDS (DAIDS) under a Material Evaluation Agreement (MEA) that will allow for the pre-clinical assessment of the most promising maturation inhibitor compounds. The goal of the effort is the identification of lead drug candidates to advance into studies that will support the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration.
The collaboration will allow DFH to further expedite the development of its 2nd generation maturation inhibitor drugs by utilizing NIAID's extensive network of in-house experts and external contractors to rapidly evaluate the development potential of a number of promising maturation inhibitor lead candidates. Initial efforts will focus on 2nd generation compounds —DFH-055 and DFH-110— which have demonstrated potent activity against all HIV strains, including those that proved resistant to the first-in-class maturation inhibitor, bevirimat. Drug development experts agree that the increased spectrum of antiviral activity exhibited by these 2nd generation development candidates is key to the successful development of a maturation inhibitor drug.
"We are very excited to be working with NIAID in the evaluation of these promising 2nd generation maturation inhibitor lead candidates," said Dr. David Martin, DFH Pharma Chief Development Officer. Dr. Martin continued, "The collaboration will allow DFH access to world-class HIV drug development experts and help the company to achieve its primary goal of returning this exciting class of HIV drug to the clinic. The identification of compounds with the required antiviral activity profile was the first step in this effort. The next step is determining the drug development potential of these exciting lead candidates and the NIAID collaboration will allow DFH to expedite this process."
About Maturation Inhibitors
Maturation inhibitors are a novel class of antiretroviral drug candidates that inhibit HIV-1 replication by interfering with virus maturation. Specifically, drugs in this class interfere with the last step in the processing of the HIV-1 Gag protein. This interference leads to the formation of noninfectious, immature virus particles, thus preventing subsequent rounds of HIV infection. As expected for a novel mechanism of action, these drugs retain inhibitory activity against HIV-1 isolates resistant to all classes of currently approved drugs commonly used by HIV infected patients. DFH plans to develop maturation inhibitors for application in both first-line and salvage therapy.
The clinical proof-of-concept for maturation inhibitors was established in a monotherapy study in HIV-infected patients with the first-in-class inhibitor bevirimat. While this first-generation drug candidate was shown to be safe and well-tolerated with potent antiviral activity in some patients, only limited activity was observed in other patients. The focus of the 2nd generation program is to identify drug candidates with potent activity against all HIV-1 strains, including those that exhibit reduced sensitivity to first-generation compounds.
About DFH Pharma, Inc.
DFH Pharma was founded by Carl Wild, PhD and Dr. Martin in 2011. Dr. Wild was a co-founder of Panacos Pharmaceuticals and served as the Chief Scientific Officer. He serves as the company's President and Chief Executive Officer as well as on the Board of Directors. While at Duke University, Dr. Wild discovered the Fusion Inhibitor class of HIV drugs and invented the first approved member of that drug class, Fuzeon® (Enfuvirtide). Dr. Martin was Senior Vice President, Drug Development and Regulatory Affairs at Panacos. He serves as the Chief Development Officer and on the Board of Directors. While at Panacos, Drs. Wild and Martin played critical roles in the development of bevirimat, the first-in-class maturation inhibitor drug. Together, the DFH Pharma team has more than 60 years of experience in antiviral drug discovery and development.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.
Carl Wild, PhD
Telephone: (301) 461-4231
David E. Martin, PharmD
SOURCE DFH Pharma, Inc.