IND Filed for HIV Fusion Inhibitor

Applied Genetics News,  May, 1999  

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Trimeris, Inc. (4727 University Dr., Suite 100, Durham, NC 27707; Tel: 919/419- 6050, Fax: 919/419-6051) has filed an investigational new drug application (IND)

for T-1249 with the Food and Drug Administration (FDA), its second entry in a new class of anti-HIV drugs that block entry of the virus into cells. The FDA's 30 day review period has passed and the company plans to initiate a phase I clinical trial in this quarter.

T-1249 is a synthetic peptide that blocks fusion of HIV with host cells. The drug has high potency in in vitro tests as well as in an animal model of HIV infection. T-1249 is active against HIV isolates that are resistant to T-20, the first fusion inhibitor, currently in phase II trials.

The first T-1249 clinical trial will be a multi-center study to evaluate safety, pharmacokinetics and antiviral activity of the drug in HIV infected adults. Up to 60 patients will receive T-1249 monotherapy by subcutaneous injection. Once a day dosing will be explored in this first trial. "We are excited about T-1249 because it possesses unique properties and demonstrates our capability to engineer novel peptide fusion inhibitors," says Dani Bolgnesi, CEO of Trimeris.

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