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CeNeRx
BioPharma Announces Successful Completion of Phase I
Clinical Program for Novel Antidepressant Agent Tyrima™
Tyrima Exhibits Excellent Safety Profile and
Favorable Pharmacokinetics in Phase I Studies
RESEARCH TRIANGLE PARK, NC, January 15, 2008 -- CeNeRx
BioPharma, Inc., a clinical stage company developing and
commercializing innovative treatments for diseases of
the central nervous system, today announced the
successful completion of the Phase I clinical program
for Tyrima™, its lead candidate for the treatment of
depression and anxiety. Tyrima is a selective and
reversible member of a novel class of drugs known as
RIMAs, or reversible inhibitors of monoamine oxidase A.
The Phase I program included acute dose, repeat dose and
fed-fasted studies. The results of all studies were
favorable, showing that Tyrima was safe and well
tolerated and exhibited good pharmacokinetic properties.
“Tyrima has the potential to be the first triple-action
anti-depressant capable of treating a broad patient
population, and we are very pleased with the safety and
tolerability observed in the Phase I clinical program,”
said Dr. Daniel Burch, R&D head and chief medical
officer of CeNeRx. “Monoamine oxidase A inhibitors
(MAOI) have demonstrated efficacy advantages over
conventional anti-depressants, but their use has been
limited by their potential for serious adverse food
effects. In these Phase I studies, Tyrima demonstrated
good safety and excellent drug-like properties, with a
positive pharmacokinetic profile at all doses tested and
minimal signs of fed-fasted effects. We look forward to
initiating the Phase Il program in the second quarter of
2008.”
Like conventional MAOI agents, the triple action
mechanism of Tyrima elevates the levels of three key
neurotransmitters (serotonin, norepinephrine and
dopamine) that positively affect mood and anxiety. In
contrast, most of the current leading antidepressant
drugs affect only the single neurotransmitter serotonin.
However, unlike older MAOIs, the unique selectivity and
reversibility of CeNeRx’s Tyrima should enable patients
to benefit from the efficacy advantages of the class
while avoiding the food-associated cardiovascular side
effects of older MAOIs. The potential for these adverse
effects has greatly restricted the use of conventional
MAOI agents.
The Phase I program evaluated a range of Tyrima doses in
65 subjects. The repeat dose study results confirmed the
positive findings of the acute dose trial that were
reported previously. Tyrima was well tolerated, with no
clinically significant adverse events reported at any
dose. It achieved high plasma concentrations and
exhibited a favorable pharmacokinetic half-life
consistent with once or twice daily dosing.
“Successful completion of the Phase I program is a major
milestone for our third generation RIMA agents, whose
triple-action mechanism has the potential to provide
greater anti-depressant efficacy to the many patients
who do not obtain adequate relief from currently
available therapies,” said Barry Brand, chief executive
officer of CeNeRx. “Tyrima offers a mechanism of action
that is well-precedented and it has novel safety
advantages. We look forward to rapidly advancing the
Phase Il program.”
CeNeRx has worldwide rights to develop and commercialize
Tyrima. This compound, which could be the first RIMA
antidepressant available in the U.S. market, has patent
protection beyond 2027.
About CeNeRx BioPharma
CeNeRx (SEN-er-ex) is a privately held clinical stage
biopharmaceutical company developing and commercializing
innovative treatments for diseases of the central
nervous system. CeNeRx’s most advanced compound, a
reversible inhibitor of monoamine oxidase, or RIMA, has
completed Phase I development for the treatment of major
depressive disorder. RIMAs may have efficacy advantages
over current agents for depression and are expected to
have a good safety profile. The company is also
developing its preclinical pipeline of selective
cannabinoid compounds for the treatment of pain,
glaucoma and obesity. More information about CeNeRx
BioPharma can be found at
www.cenerx.com.
Contact:
GendeLLindheim BioCom Partners
Barbara Lindheim
212 918 4650
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