Trimeris Begins Patient Selection and Dosing in Next T-20 Phase II Trial; First Long-Term Combination Studies Underway

Trimeris Begins Patient Selection and Dosing in Next T-20 Phase II Trial; First Long-Term Combination Studies Underway

Business Wire - June 23, 1999

DURHAM, N.C.--(BW HealthWire)--June 23, 1999--Trimeris, Inc. (NASDAQ:TRMS) announced today that patient selection and dosing have begun in its T20-206 Phase II clinical trial for T-20. The trial will assess the antiviral activity and long-term safety of T-20 when used in combination with other anti-HIV drugs.

T20-206 will evaluate four groups of patients over a one-year period with analyses at 16 weeks and 48 weeks. Three different doses of T-20 will be combined with a background regimen of amprenavir, efavirenz, ritonavir and abacavir. The control group will receive the background regimen without T-20. T20-206 will enroll up to 68 HIV-infected individuals at up to 12 sites in the United States. At entry all enrolled patients will have prior exposure to nucleoside reverse transcriptase inhibitors and protease inhibitors, but no prior exposure to non-nucleoside reverse transcriptase inhibitors.

"In the first two human trials of T-20, we evaluated the short-term activity of T-20 when administered as a single agent. The data showed that T-20 has a potency, safety and resistance profile comparable to existing antiretroviral agents when used as monotherapy," stated Dr. Dani P. Bolognesi, Chief Executive Officer of Trimeris. "We are excited to begin the T20-206 trial and evaluate T-20 in the manner that it will be used clinically, which is in combination with other antivirals."

Two presentations on HIV fusion inhibitors will be given by Trimeris researchers at the 3rd International Workshop on HIV Drug Resistance and Treatment Strategies this week in San Diego. The first will characterize selected isolates from patients in the TRI-003 trial which confirm previously published observations of resistance in vitro. The second presentation will describe the potent in vitro effect of T-1249, Trimeris' second fusion inhibitor, on these T-20 resistant clinical isolates.

Patients from the TRI-003 are continuing to receive T-20 in a long-term open label roll-over protocol, (T20-205). This study permitted the participants to add T-20 in combination with an antiretroviral regimen customized to the individual's treatment history, after the 28-day monotherapy completed in TRI-003. The results from this trial are expected to be available in the third quarter of 1999.

Trimeris is a development stage, biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. The Company's lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase II clinical trials and has received fast track designation from the FDA. The Company's second product candidate, T-1249, which also inhibits HIV fusion, has received fast track designation from the FDA and is in a Phase I clinical trial.

Note: Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of the company's previous clinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from the results presented herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in the Company's Form 10-Q for the three months ended March 31, 1999 filed with the Securities and Exchange Commission on May 17, 1999 and the Company's Registration Statement on Form S-3 as declared effective by the Securities and Exchange Commission on May 26, 1999.

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CONTACT: Trimeris Inc., Durham Matthew A. Megaro President and Chief Financial Officer 919/419-6050 or Burns McClellan Inc., New York Jonathan M. Nugent (investors) Justin Jackson (media) 212/213-0006
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BW990610

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