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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) April 18, 2002 Commission File Number 0-23155
TRIMERIS, INC.
(Exact name of registrant)
Delaware 56-1808663
(State of organization) (I.R.S. Employer Identification Number)
3518 Westgate Drive, Suite 300, Durham, North
Carolina 27707 (Address of principal executive offices and zip code)
(919) 419-6050
(Registrant's telephone Number)
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ITEM 5. OTHER EVENTS
The Company is hereby filing the following information regarding its business:
Roche and Trimeris, Inc. announced on April 18, 2002, positive 24-week results
from the first pivotal Phase III study of T-20, the furthest in clinical
development of an investigational class of antiretrovirals called fusion
inhibitors. The results from this first study (TORO 1: T20-301) as well as the
results from a second ongoing study (TORO 2: T20-302) will form the basis of the
submission to regulatory authorities.
In the TORO 1 study, T-20 administered in combination with an individualized
antiretroviral treatment regimen was shown to provide a significant additional
decrease in the amount of virus in the blood as compared to an individualized
antiretroviral treatment regimen alone. TORO 1 was conducted in 491 HIV-1
infected patients who were treatment-experienced and/or had documented
resistance to each of the three classes of currently available antiretrovirals.
At baseline, patients had a median HIV RNA level of over 5 log\\10\\ copies/mL
and extensive prior exposure to multiple anti-HIV drugs. Patients who received
T-20 as part of their combination regimen achieved a reduction in HIV levels of
1.697 log\\10\\ copies/mL compared to 0.763 log\\10\\ copies/mL for those who
were randomized to the control arm, calculated in accordance with the study
protocol. The primary efficacy endpoint for the study, the difference in the
magnitude of decrease in HIV between the two arms, was 0.934 log\\10\\ copies/mL
and was statistically significant (p*0.0001). Roche and Trimeris expect to
present these data in detail at scientific conferences in the next several
months.
Safety Results
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Through 24 weeks, the incidence of grade 3 and 4 laboratory abnormalities and
clinical adverse events was similar between the T-20 and control arms.
Additionally, drug discontinuation at 24 weeks was approximately 10 percent
overall and was very similar in both arms. While most patients on the T-20 arm
experienced injection site reactions, only 3 percent of patients discontinued
the study as a consequence. Other adverse events **10 percent), where the
incidence was greater on the T-20 arm than on control, were insomnia, headache,
peripheral neuropathy, and dizziness. It was not possible to establish a causal
relationship between these other adverse events and T-20.
Study Design
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TORO 1 (T-20 vs. Optimized Regimen Only), previously known as T20-301, and TORO
2 (previously known as T20-302) are randomized, open-label trials that enrolled
approximately 1,000 patients at 112 centers worldwide. TORO 1 is being conducted
in North America and Brazil, while TORO 2 is being conducted in Australia,
Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland and
the United Kingdom. Patients in the trials were treatment-experienced and/or had
documented resistance to each of the three classes of currently-available
antiretrovirals. In addition, each patient was required to have a plasma HIV-RNA
level of greater than 5,000 copies/mL. Patients are expected to undergo
treatment for 48 weeks, with an optional 48-week treatment extension.
At entry, genotypic and phenotypic resistance testing was used to aid in the
selection of an antiretroviral regimen, consisting of three to five drugs,
including if appropriate, up to two newly approved or investigational drugs.
After selection of the regimen, patients were randomized 2:1 to receive either
the regimen in combination with T-20 or the regimen alone. Patients randomized
to T-20 receive T-20 administered as one 90 mg subcutaneous self-injection
twice-daily.
Early Access to T-20
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In November 2001, Roche and Trimeris announced the initiation of the T-20
open-label safety study (T20-305) to provide T-20 to 450 patients around the
world. The study is ongoing and is being conducted in Australia, Brazil, Europe,
and North America. An expansion of this trial over the next several months will
continue to make T-20 available prior to approval for patients with advanced HIV
disease who are unable to construct a viable antiretroviral regimen with
currently approved agents. Additionally, Roche and Trimeris are committed to
starting early access programs in the second half of this year when increased
drug supply is expected to be available.
Meeting the Growing Need For a New Class of HIV Drugs
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One of the biggest challenges facing people living with HIV is resistance to
currently available therapies. Thirty to fifty percent of patients are infected
with a strain of the virus that has developed resistance to one or more
antiretrovirals, thereby reducing the treatment options available to them. Roche
and Trimeris are committed to discovering and developing treatments for patients
in need of new options and expect to invest approximately half a billion U.S.
dollars to bring fusion inhibitors to people living with HIV/AIDS.
* less than
** greater than
Long-Term Commitment to HIV Research and Development
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Roche and Trimeris are working together to mobilize the considerable resources
required to support the rapid development of T-20, the first member of a new
class of investigational anti-HIV drugs known as fusion inhibitors. T-20,
currently in Phase III clinical trials, is the furthest along in clinical
development in the entry inhibitor class. T-1249, a second generation fusion
inhibitor being developed by Roche and Trimeris, is in Phase I/II clinical
trials. Unlike existing AIDS drugs that work inside the cell and target viral
enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV
with host cells before the virus enters the cell and begins its replication
process. In June 2001, Roche and Trimeris announced a joint research agreement
to identify and develop additional HIV fusion inhibitor peptides.
T-20 has fast track designation from the FDA in the U.S. for the treatment of
HIV-infected individuals. Fast track is granted to facilitate the development
and expedite the review of applications for drugs that are intended to treat
serious or life-threatening disease and that demonstrate the potential to
address an unmet medical need.
Trimeris Safe Harbor Statement
Note: Except for any historical information presented herein, matters presented
in this current report are forward-looking statements that involve risks and
uncertainties. The results of Trimeris' 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 Trimeris' Form 10-K for the year ended
December 31, 2001 filed with the Securities and Exchange Commission on March 25,
2002.
SIGNATURE
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
TRIMERIS, INC.
By: /s/ Dani P. Bolognesi
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Dani P. Bolognesi
Chief Executive Officer and Chief
Scientific Officer
Dated: April 22, 2002