CorporateR&d
Almirall's respiratory pipeline update: Aclidinium bromide and LAS100977 (once daily LABA)
·Almirall and Forest have started implementing a programme aimed at satisfying both US and EU regulatory requirements for aclidinium bromide.
·Positive results obtained from the third Phase IIa study with LAS100977, the once-a-day long-acting beta agonist (LABA) in asthma patients.
Barcelona, 30th April 2009 – Further to recent communications, Almirall announces an update on its respiratory pipeline, as follows:
Aclidinium bromide
After discussions held with the USA Food and Drug Administration (FDA) and regulatory authorities in some European (EU) countries during 2009, Almirall and Forest have agreed on the future clinical and regulatory strategy for the aclidinium bromide monotherapy program.
As announced last March 6th, the FDA requested further information about the dosing and treatment regimen before regulatory filing. In Europe, the consulted authorities agreed, based on their initial view, that the compound had shown efficacy and safety in the ACCLAIM studies. Additionally, the EU authorities also provided feedback to the proposed programme for higher and/or more frequent dosing.
Based on this response, Almirall and Forest have started implementing a programme aimed at satisfying both US and EU regulatory requirements to provide further support for higher and/or more frequent dosage regimens. More detail will be provided on this programme later in the year. The current tentative target filing date for this programme is late 2011/early 2012 for both the US and Europe.
For the aclidinium plus formoterol combination, as well as a future potential combination of aclidinium plus an inhaled corticosteroid (ICS), a new twice-daily (BID) programme will facilitate and potentially accelerate the development strategy.
The franchise opportunity of aclidinium bromide is based on Genuair®1, Almirall’s unique dry powder inhaler device. The ease of use and functionality of the inhaler device is an important factor in delivering the correct dose to the lungs to ensure effective COPD treatment.
LAS100977 (Once-daily LABA)
Almirall also announces positive results from a third Phase IIa study with the once-a-day long-acting beta agonist (LABA) LAS100977 in asthma patients. As in the previous two studies, LAS100977 was safe and showed a clinically and statistically significant bronchodilator effect.
The study forms part of a package of three Phase IIa clinical trials to evaluate dosing, dose regimen, safety and tolerability, in order to ensure a correct dose selection for Phase IIb and COPD studies.
Almirall is holding discussions with potential partners for development and marketing collaborations of LAS100977.
·About the study
This single dose, randomised, four-period cross-over efficacy and safety clinical trial, included 28 mild-moderate persistent asthmatic patients. All patients were on stable doses of an inhaled corticosteroid. Patients were randomised to inhale once, one of three doses of LAS100977 or placebo in each treatment period, using a dry powder uni-dose capsule inhaler.
The primary efficacy variable was change from pre-dose in trough FEV1 (mean FEV1 between 23 and 24h post-dose). Other pulmonary function tests (FEV1, FVC, PEF and FEF25-75) (*)and safety parameters (adverse events, vital signs, ECGs) were measured at scheduled time points over 48 hours.
Results showed a statistically and clinically significant increase in change from pre-dose trough FEV1 vs placebo for all doses of LAS100977, as well as a sustained significant effect over a 24 hour period. In addition, LAS100977 provided a quick onset of action five minutes after the first administration. All doses tested were very well tolerated with no treatment emergent adverse events related to drug class effect.
The results of this study, in terms of efficacy, duration of action, and safety are consistent to that seen in the previous studies.
LAS100977 will be developed using Genuair®, a novel, state-of-the-art, multi-dose dry powder inhaler (MDPI). Genuair® was designed with a click and colour feedback system which, through a ‘coloured control window’ and an audible click, indicates that the patient has inhaled correctly. The Genuair® inhaler incorporates significant safety features such as a visible dose indicator, an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.
About Almirall
Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, Almirall researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.
The therapeutic areas on which Almirall focuses its research resources are related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and dermatology.
Almirall is currently present in over 70 countries with direct presence in Europe and Latin America through 11 affiliates.
For further information: www.almirall.com
(*)
|
Acronym
|
Meaning
|
|
FEV1
|
Forced Expiratory Volume in the first Second
|
|
ECG
|
Electrocardiogram
|
|
FVC
|
Forced Vital Capacity
|
|
PEFR
|
Peak Expiratory Flow Rate
|
|
FEF
|
Forced expiratory Flow
|
[1] Genuair is a registered trademark of Laboratorios Almirall, S.A. It is the proposed registered trademark for the Multiple-Dose Dry Powder Inhaler (MDPI) and is pending regulatory approval.