Trimeris Inc., with strong enough data in hand to propose a public offering when few others dare, registered to sell 2.3 million shares in an offering that could raise as much as $111 million for funding clinical development and commercialization of Fuzeon for HIV.

The money also would be used to fund research and development for a second candidate for HIV, T-1249.

The Durham, N.C., company has fast-track status from the FDA for two peptides, Fuzeon (enfuvirtide, formerly called T-20), and T-1249, both of which are being co-developed for HIV by Hoffmann-La Roche Inc., of Nutley, N.J. (See BioWorld Today, April 19, 2002.)

The $111 million total is based on an estimated maximum price per share of $48.29. Trimeris' stock (NASDAQ:TRMS) fell $2.44 Friday to close at $47.55. Of the 2.3 million shares, 300,000 are for an overallotment option for underwriters.

The company declined to comment on the proposed offering, but said in May that it plans to file the new drug application for Fuzeon in the second half of the year.

Trimeris would have about 20.8 shares outstanding following the stock offering, the company said in its S-3 filing.

As of June 30, Trimeris had $87.4 million in cash, with a net loss for the second quarter of $16.1 million, compared to a net loss of $15.2 million in the second quarter of 2001. In January, Trimeris entered into agreements to sell about 1.27 million shares of newly issued common stock, a private placement that netted about $41 million. At that time, an officer of the company said that he expected that money to give the company about a year and a half of cash. (See BioWorld Today, Jan. 28, 2002.)

Trimeris reported positive 24-week results in May from its second pivotal Phase III trial of Fuzeon. Fuzeon is one of an investigational class of drugs called fusion inhibitors, which work to block a virus before it enters and takes over a host cell. Fusion inhibitors are one of three types of entry inhibitors. The two others are attachment inhibitors and co-receptor inhibitors.

Fuzeon is a peptide drug made up of 36 amino acids and is the most advanced in Trimeris' pipeline. It is administered as a twice-daily subcutaneous injection. In early July, Trimeris reported final results of Phase I/II trials that demonstrated T-1249, a second-generation fusion inhibitor candidate, was well tolerated and exhibited antiviral activity in HIV patients.

At the XIV International AIDS Conference in Barcelona, Spain, in July, Trimeris reported that data from two Phase III trials of T-20, called TORO 1 and TORO 2, showed it was effective in combination therapy. The data indicated that combination therapy with T-20 reduced HIV to undetectable levels in the blood in at least twice the percentage of patients than those who did not take the drug. (See BioWorld Today, July 9, 2002.)

TORO 1 enrolled 491 patients who previously had been treated with 12 antiretroviral agents. Fifty-two percent of patients receiving T-20 experienced a 1.0 log¹⁰ or greater reduction in HIV levels.

TORO 2 enrolled 504 patients who previously had been treated with 11 antiretroviral drugs. Twenty-eight percent of patients who received T-20 in combination with an optimized background regimen had undetectable blood levels (less than 400 copies/mL) of HIV at 24 weeks, compared to 14 percent receiving an optimized background regimen alone (p<0.0001).

The offering is being conducted by a group of underwriters led by Morgan Stanley & Co. Inc., of New York, and Goldman, Sachs & Co. Inc., of New York. The co-managers are Lehman Brothers Inc., of New York, and Banc of America Securities LLC, of San Francisco.