(Adds additional company comments, details on Theravance deal)
LONDON (Thomson Financial) - GlaxoSmithKline and Theravance Inc have
announced the start of large Phase IIB asthma dose-optimisation studies with
both lead inhaled corticosteroid GW685698 ('698) and lead long-acting beta
agonist GW642444 ('444).
These clinical programmes will determine the most effective doses to be
taken into Phase III combination studies, Glaxo said.
Theravance chief executive Rick Winningham said, "We are very pleased to
have met the important milestone of initiating the larger Phase IIB studies with
the lead compound '444 and with the progress of '698."
Winningham added: "Based upon recent clinical and preclinical results, the
collaboration's confidence in the overall profile of '444 has increased and we
are focusing our resources on this compound to move it forward as quickly as
possible."
The studies will enrol in excess of 2,400 patients recruited globally, Glaxo
said.
The company added a Phase IIB chronic obstructive pulmonary disease
programme with '444 also on schedule to commence in the first half of 2008.
The study has been done as part of Glaxo's Horizon Programme, also known as
the Beyond Advair programme, designed to find sucessor products to Advair that
include both the short-acting corticosteroid inhaler and a long-acting beta
agonist.
A Glaxo spokeswoman said: "There has been some information out there about
these two molecules themselves. But clearly now it's in Phase IIB this is when
it starts to become much more meaningful, because there are bigger patient
populations and we're looking at them much more thoroughly in terms of how do
they work, at which doses, which is the most efficaceous which would you take
through to Phase III."
While Glaxo discovered and developed the inhaled corticosteroid '698, it
in-licensed the beta agonist '444 from Theravance.
ben.deighton@thomson.com
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