TIDMCIR
RNS Number : 7701O
Circassia Pharmaceuticals Plc
22 May 2018
Circassia Announces Positive Data Presented at 2018 American
Thoracic Society Conference from Tudorza(R) Phase IV and Duaklir(R)
Phase III Studies
Oxford, UK - 22 May 2018: Circassia Pharmaceuticals plc
("Circassia" or "the Company"; LSE: CIR), a specialty
pharmaceutical company focused on respiratory disease, today
announces the presentation of positive clinical data from the
Tudorza(R) Pressair(R) phase IV ASCENT study and Duaklir(R)
Pressair(R) phase III AMPLIFY study at the American Thoracic
Society (ATS) 2018 International Conference currently being held in
San Diego, CA.
Steve Harris, Circassia's CEO, said: "With both the ASCENT and
AMPLIFY studies meeting their primary endpoints, the positive data
presented at the American Thoracic Society conference are highly
supportive for Tudorza(R) and Duaklir(R). As a result, we look
forward to regulatory filings in the coming weeks seeking US
approval for Duaklir(R) and an extension to Tudorza(R)'s US
prescribing information to include the ASCENT data."
ASCENT phase IV results(1)
ASCENT evaluated the long-term effect of the long-acting
muscarinic antagonist (LAMA) Tudorza(R) (aclidinium 400ug
twice-daily) on cardiovascular safety and chronic obstructive
pulmonary disease (COPD) exacerbations. The study was conducted in
approximately 3,600 patients with moderate to very severe COPD and
cardiovascular disease and / or risk factors. ASCENT was unique in
that 48% of patients enrolled had at least one documented previous
cardiovascular event while 96% of patients included had at least
two atherothrombotic risk factors. ASCENT met its primary
endpoints, demonstrating that Tudorza(R) is effective at reducing
exacerbations with no increase in cardiovascular events in this
at-risk population. The ATS conference oral presentation included a
number of outcome measures:
-- Primary endpoint: Tudorza(R) reduced the rate of moderate to severe COPD exacerbations by 22% vs placebo
(p<0.001) during the first year of treatment.
-- Primary endpoint: the time to a first major adverse cardiovascular event was similar for Tudorza(R) and placebo
(hazard ratio 0.89; p=0.464).
-- Secondary endpoint: Tudorza(R) reduced hospitalisations due to COPD exacerbations by 35% vs placebo (p=0.006) in
the first year of treatment.
Cardiovascular disease is the most common and significant
comorbidity of COPD, with approximately 30% of COPD patients dying
from cardiovascular conditions. Submission of a supplemental New
Drug Application (sNDA) for Tudorza(R) is anticipated in the coming
weeks to request inclusion of the ASCENT data in the treatment's US
prescribing information. If successful Tudorza(R) will be the only
LAMA marketed in the United States with COPD exacerbation reduction
data and data demonstrating safety in patients with cardiovascular
disease / risk factors in its label.
AMPLIFY phase III results(2,3)
AMPLIFY evaluated the efficacy of Duaklir(R) (aclidinium 400ug /
formoterol 12ug twice-daily) compared with the product's individual
components. The study, which was conducted in more than 1,500 COPD
patients over 24 weeks, met its co-primary efficacy endpoints. The
ATS conference presentation included both co-primary endpoints and
data from a sub-study of 24-hour bronchodilation that compared
twice-daily Duaklir(R) with the once-daily LAMA, tiotropium
(Spiriva(R) Handihaler(R)):
-- Primary endpoint: Duaklir(R) significantly increased forced expiratory volume in one second (FEV1) from baseline
one hour post dose compared with aclidinium monotherapy (253 mL vs 169 mL, p<0.0001).
-- Primary endpoint: Duaklir(R) significantly increased FEV1 from baseline prior to morning dose (trough) compared
with formoterol monotherapy (80 mL vs 25 mL, p<0.001).
-- Sub-study: Duaklir(R) significantly improved night-time and 24-hour bronchodilation (area under the curve FEV1)
compared with Spiriva(R) (150 mL vs 60 mL, p<0.001 and 167 mL vs 109 mL, p<0.05 respectively).
Submission of a New Drug Application (NDA) seeking marketing
approval for Duaklir(R) in the United States is anticipated in the
coming weeks. The NDA will include data from the AMPLIFY study,
results from two previous Duaklir(R) phase III studies, ACLIFORM
and AUGMENT, and exacerbation data from the ASCENT trial.
About Tudorza(R) and Duaklir(R)
In April 2017, Circassia and AstraZeneca established a
collaboration for the commercialisation of Tudorza(R) and
Duaklir(R) in the United States. Under the companies' agreement,
Circassia has responsibility for marketing Tudorza(R), and
AstraZeneca is responsible for completing the product's clinical
studies and regulatory filings. Circassia also has exclusive US
commercialisation rights to Duaklir(R), and AstraZeneca is
responsible for conducting the product's development and regulatory
filing.
About Pressair(R)
Pressair(R) is an easy-to-use, multi-dose, breath-activated
inhaler with a unique patient feedback mechanism that is approved
in the US for delivering Tudorza(R) (aclidinium bromide) and is
being used for the development of Duaklir(R) in the United States.
Outside the US the Pressair(R) inhaler is marketed as
Genuair(R).
About Circassia
Circassia is a world-class specialty pharmaceutical business
focused on respiratory disease. Circassia sells its novel,
market-leading NIOX(R) asthma management products directly to
specialists in the United States, United Kingdom and Germany, and
in a wide range of other countries through its network of partners.
In 2017, the Company established a commercial collaboration with
AstraZeneca in the United States in which it promotes the chronic
obstructive pulmonary disease (COPD) treatment Tudorza(R), and has
the commercial rights to pre-NDA COPD product Duaklir(R). For more
information please visit www.circassia.com/
Contacts
Circassia
Steve Harris, Chief Executive Officer Tel: +44 (0) 1865 405
560
Julien Cotta, Chief Financial Officer
Rob Budge, Corporate Communications
JP Morgan Cazenove
James Mitford / James Deal Tel: +44 (0) 20 7742 4000
Numis Securities
Clare Terlouw / Freddie Barnfield Tel: +44 (0) 20 7260 1000
FTI Consulting
Simon Conway / Mo Noonan Tel: +44 (0) 20 3727 1000
Forward-looking statements
This press release contains certain projections and other
forward-looking statements with respect to the financial condition,
results of operations, businesses and prospects of Circassia. The
use of terms such as "may", "will", "should", "expect",
"anticipate", "project", "estimate", "intend", "continue", "target"
or "believe" and similar expressions (or the negatives thereof) are
generally intended to identify forward-looking statements. These
statements are based on current expectations and involve risk and
uncertainty because they relate to events and depend upon
circumstances that may or may not occur in the future. There are a
number of factors that could cause actual results or developments
to differ materially from those expressed or implied by these
forward-looking statements. Any of the assumptions underlying these
forward-looking statements could prove inaccurate or incorrect and
therefore any results contemplated in the forward-looking
statements may not actually be achieved. Nothing contained in this
press release should be construed as a profit forecast or profit
estimate. Investors or other recipients are cautioned not to place
undue reliance on any forward-looking statements contained herein.
Circassia undertakes no obligation to update or revise (publicly or
otherwise) any forward-looking statement, whether as a result of
new information, future events or other circumstances.
(1) Wise R et al. Effects of aclidinium bromide on major adverse
cardiovascular events and COPD exacerbations in patients with COPD
and cardiovascular risk factors. Late breaker Abstract (A7711)
accepted for oral presentation (some p-values updated for oral
presentation).
(2) Sethi S et al. AMPLIFY: a randomised, phase III study
evaluating the efficacy and safety of aclidinium/formoterol versus
monotherapy in patients with COPD. Abstract A4241/615
(3) Kerwin E et al. Effect of twice-daily aclidinium/formoterol
versus monotherapy or tiotropium on 24-hour bronchodilation and
symptom control in patients with COPD: results from AMPLIFY.
Abstract A4235/609.
Aclidinium is marketed under a number of brand names around the
world, including Tudorza(R), Eklira(R) and Bretaris(R)
Duaklir(R) is a registered trademark in Europe and other
markets; use of the US trademark is subject to review and approval
by the FDA
Duaklir(R) and Tudorza(R) are registered trademarks of Almirall
S.A.; Pressair(R) is a registered trade mark of the AstraZeneca
group of companies
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END
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