Announcement no. 22/2007
To the OMX Nordic Exchange Copenhagen, November 19,
2007
Curalogic has commenced a Phase III clinical study with the grass product
Summary: Curalogic has commenced treatment of the first patients in a Phase III
clinical study with the product for the treatment of grass allergy. Based on
data from the study, Curalogic plans to file a registration application in
Europe in H2 2009. The market for Curalogic's grass product is large as about 51
million people in Europe and about 30 million people in the United States suffer
from grass allergy.
Curalogic has dosed the first patients in the Phase III clinical study (GPE 03)
with the product for the treatment of grass allergy. The study is conducted in a
number of European countries, and more than 600 patients will be treated before
and through the 2008 grass pollen season.
It is expected that results from the study will be announced in the first
quarter of 2009, and Curalogic plans to file a registration application for the
grass product in Europe in the second half of 2009.
Peter Moldt, CEO of Curalogic said: “With the commencement of the GPE 03 study,
Curalogic now has 2 products in the final clinical Phase III, and this means
that we are one important step closer to our goal of making patient friendly and
effective allergy treatment available for allergy patients. In the planning of
the GPE 03 study, Curalogic has focused on optimizing the patient selection. We
have as something new, introduced a provocation test where we test if the
patients have allergy symptoms upon exposure to the grass allergen.”
And Peter Moldt continues: “In our Phase III clinical study for ragweed allergy
(RPE 04), we have also taken extra precautions in the patient selection,
requiring documentation of the patient's disease history for the last couple of
years. When we look at the development of the averaged allergy symptom score
from all patients in this study, we can see that the patients have a good
increase in symptoms in the ragweed pollen season. The RPE 04 study is still
blinded, and it is still too early to determine if the study is positive, but
the preliminary results indicate that we have enrolled the right patients in the
study.”
Design of the Phase III clinical study
GPE 03 is a double-blinded, randomized, placebo-controlled study to evaluate the
efficacy and safety of two doses of orally administered grass pollen extract to
patients who suffer from grass allergy. Patients with moderate to severe grass
allergy will be treated daily with one of the two active doses or placebo.
Treatment will begin at least eight weeks prior to and will continue through the
grass pollen season. The grass pollen season begins in May and lasts throughout
the summer. The primary objective of the study is to evaluate the effect of the
treatment measured as a total allergy symptom score (TSS). Dr. Jörg Kleine-Tebbe
of the Allergy & Asthma Center Westend, Germany, is the principal investigator
of the study.
Curalogic's product for the treatment of grass allergy
The active ingredient of the grass product is an extract of pollen from Timothy
grass (Phleum pratense L.).
Curalogic's microbead formulation has been used to administer grass pollen
extract in two clinical studies: one in the United States and one in Europe. The
trials included a total of 93 patients with moderate to severe grass allergy who
were dosed on a daily basis for 1 to 10 weeks. The highest dose tested is 64,000
BAU, which is approximately 30 times higher than the maintenance dose with
injection immunotherapy recommended in the US. No treatment-related serious
adverse events or anaphylactic reactions were reported in the trials. The grass
product was well-tolerated, both with and without updosing, and the adverse
events were similar in nature to those observed for the ragweed product.
Grass allergy
About 51 million people in Europe and 30 million people in the United States
suffer from grass allergy.
Yours sincerely
Curalogic A/S
For additional information, please contact:
Peter Moldt, President and CEO Phone +45 99 99 24 00, mobile +45 26 25 04 22
Helle Busck Fensvig, EVP and CFO Phone +45 99 99 24 00, mobile +45 20 70 55 37
About Curalogic
Curalogic is a Danish biopharmaceutical company listed on the OMX Nordic
Exchange (CUR.CO) as a small cap + company. Curalogic develops innovative
products for the treatment of allergy using a patented formulation technology.
The products combine the efficacy of immunotherapy with the patient friendliness
of antihistamines and have the potential to become the preferred type of allergy
treatment among patients. Curalogic has a broad and mature pipeline of products
for the treatment of ragweed allergy and grass allergy in Phase III, a product
for the treatment of cat allergy in Phase II and a product for the treatment of
house dust mite allergy being prepared for clinical trials.
This announcement contains forward-looking statements regarding the Company's
future financial development and performance and other statements which are not
historical facts. Such statements are made on the basis of assumptions and
expectations which, to the best of the Company's knowledge and belief, are
reasonable, at this time, but may prove to be erroneous in the future.
