Actelion provides an update on the Phase III IMPACT program with cadazolid in CDAD
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion provides an update on the Phase III IMPACT program with cadazolid in
CDAD
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The issuer is solely responsible for the content of this announcement.
ALLSCHWIL, SWITZERLAND - 08 June 2017 - Actelion Ltd (SIX: ATLN) today provided
an update on the Phase III program IMPACT to investigate the efficacy and safety
of Actelion's novel anti-infective cadazolid versus vancomycin in the treatment
of Clostridium difficile-associated diarrhea (CDAD). In the pivotal program,
IMPACT 1 met its primary endpoint, while the second study IMPACT 2 did not meet
the primary endpoint. Cadazolid demonstrated an acceptable tolerability and
safety profile in the IMPACT program.
IMPACT 1 and 2 compared the efficacy and safety of cadazolid (250 mg
administered orally twice daily for 10 days) versus vancomycin (125 mg
administered orally four times daily for 10 days). A total of 1263 patients
worldwide participated in the IMPACT program, which assessed as primary endpoint
whether the clinical response after administration of cadazolid is non-inferior
to vancomycin in patients with CDAD.
The company will now work diligently to complete the analyses of the full study
results and detailed results will be made available through scientific
disclosure at upcoming congresses and in peer-reviewed publications.
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NOTES TO EDITOR:
ABOUT THE IMPACT PROGRAM
The IMPACT program (International Multi-center Program Assessing Cadazolid
Treatment in patients suffering from Clostridium difficile-associated diarrhea)
comprised two identical Phase III studies that were designed as multi-center,
randomized, double-blind studies to compare the efficacy and safety of cadazolid
versus vancomycin in patients with Clostridium difficile-associated diarrhea
(CDAD). Primary endpoint of the studies was the clinical cure rate at end of
treatment (+ 2 days). The clinical cure rate was defined as the resolution of
diarrhea (less than or equal to 3 unformed bowel movements per days for at least
2 consecutive days) and no further need for CDAD therapy on study treatment and
maintained for 2 days after the end of study treatment.
ABOUT CADAZOLID
Cadazolid, a novel quinoxolidinone antibiotic, is a strong inhibitor of
Clostridium difficile protein synthesis, leading to suppression of toxin
production and spore formation. In preclinical studies, cadazolid showed potent
in vitro activity against C. difficile isolates and a low propensity for
resistance development. In a human gut model of CDAD, cadazolid had a very
limited impact on the normal gut microflora.
Cadazolid was previously investigated in a randomized, double-blind, active
reference group Phase II study, with 84 patients randomized 1:1:1:1 to
250, 500, or 1,000 mg cadazolid or oral 125 mg vancomycin. The results provided
proof of concept for the efficacy and safety of cadazolid for the treatment of
CDAD and supported the progression to the Phase III program with a cadazolid
dose of 250 mg BID.
ACTELION LTD
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery,
development and commercialization of innovative drugs for diseases with
significant unmet medical needs.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our
portfolio of PAH treatments covers the spectrum of disease, from WHO Functional
Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
Although not available in all countries, Actelion has treatments approved by
health authorities for a number of specialist diseases including Type 1 Gaucher
disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from
systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.
Founded in late 1997, with now over 2,500 dedicated professionals covering all
key markets around the world including Europe, the US, Japan, China, Russia and
Mexico, Actelion has its corporate headquarters in Allschwil / Basel,
Switzerland. Actelion shares are currently traded on the SIX Swiss Exchange
(ticker symbol: ATLN). All trademarks are legally protected.
For further information please contact:
Andrew Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
http://www.actelion.com
The above information contains certain "forward-looking statements", relating to
the company's business, which can be identified by the use of forward-looking
terminology such as "estimates", "believes", "expects", "may", "are expected
to", "will", "will continue", "should", "would be", "seeks", "pending" or
"anticipates" or similar expressions, or by discussions of strategy, plans or
intentions. Such statements include descriptions of the company's investment and
research and development programs and anticipated expenditures in connection
therewith, descriptions of new products expected to be introduced by the company
and anticipated customer demand for such products and products in the company's
existing portfolio. Such statements reflect the current views of the company
with respect to future events and are subject to certain risks, uncertainties
and assumptions. Many factors could cause the actual results, performance or
achievements of the company to be materially different from any future results,
performances or achievements that may be expressed or implied by such forward-
looking statements. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein as anticipated, believed,
estimated or expected.
Press release PDF:
http://hugin.info/131801/R/2111437/802791.pdf
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Source: Actelion Pharmaceuticals Ltd via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 08.06.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 546884
Anzahl Zeichen: 7097
contact information:
Town:
Allschwil
Kategorie:
Business News
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