Chimerix Completes Phase I Study and Initiates a Phase II Multi-dose Clinical Trial for CMX001
biotechnology company developing orally available antiviral therapeutics,
announced today that the Company has completed a single and multi-dose Phase I
study of CMX001 in healthy volunteers. This study supports the further
development of the drug for multiple dsDNA infections. The Company has
initiated the first Phase II multi-dose clinical trial in patients.
“The safety and high oral availability demonstrated by CMX001 in the Phase
I trial has exceeded our original expectations,” said Dr.
Chimerix President and CEO. “We believe that CMX001 has potential for
prevention and treatment of many serious and potentially fatal infections such
as smallpox, cytomegalovirus, BK virus and adenovirus.”
The Phase I study of CMX001 was a blinded, randomized, placebo-controlled
study that evaluated the safety and pharmacokinetics of orally administered
CMX001 in healthy volunteers. The study found CMX001 to be well tolerated at
all doses in 84 healthy volunteers.
The first Phase II trial will study the effects of multiple doses of
CMX001 given to stem cell and kidney transplant recipients with BK viruria, a
condition which may eventually lead to loss of the kidney graft, or to
uncontrolled bleeding in the bladder. Further studies are planned to explore
the ability of CMX001 to prevent cytomegalovirus disease, a viral disease that
may lead to blindness or severe gastrointestinal disease after bone marrow
transplant.
CMX001 is being developed for the treatment of smallpox infection and
other double stranded DNA virus infections that cause significant human
morbidity and mortality. A safe, orally active antiviral drug to treat
smallpox infection is needed to help people who become ill after exposure to
the disease or those who cannot be vaccinated. The work is partially funded
by a
Allergy and Infectious Diseases.
About Chimerix
Chimerix, Inc. discovers, develops and commercializes therapeutics with
enhanced pharmaceutical properties that are active against a broad range of
viral diseases. Leveraging a powerful lipid, prodrug technology,
ProLipTag(TM), Chimerix is able to develop drug candidates with
oral-availability, increased potency and targeted delivery. These enhanced
pharmaceutical properties can be applied to new drug moieties or known drugs
to improve dosing parameters, broaden therapeutic applications and decrease
the risk of adverse events.
SOURCE Chimerix, Inc.