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news.Spain-based pharmaceutical company Almirall has announced new Phase II multi-dose study results demonstrating that its novel once-daily, inhaled, long-acting beta-agonist-LAS100977, for the treatment of bronchoconstriction in asthmatic patients, shows fast-acting and 24-hour efficacy, as well as a good safety and tolerability profile in patients during multiple dose administrations.
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The multi-dose, placebo-controlled, three-period cross-over study, included 20 stable asthmatic patients. LAS 100977 demonstrated 24 hour bronchodilation and sustained efficacy during multiple dose administrations with no significant increase in cardiovascular adverse events. These results reaffirm the findings of previous studies which demonstrated that Almirall investigational compound is potent and selective with a good tolerance and safety profile.
Over a 24 hour period, the drug showed a sustained statistically and clinically significant effect with the three doses tested from day 1 to day 7 and provided an onset of action five minutes after the first administration. Trough and Peak FEV1 were significantly superior to placebo at all doses tested both day 1 and day 7.
The development of a once daily fixed-dose combination of LAS100977 with a corticosteroid in the Genuair inhaler is ongoing. Almirall has already started discussions with potential partners towards development and commercialization collaborations on LAS100977.
Almirall is committed to research and develop innovative drugs within the respiratory field where there are still considerable unmet medical needs. LAS 100977 along with aclidinium bromide, a long acting muscarinic antagonist, are the most advanced drugs within Almirall’s respiratory product pipeline.
Per Andersson, R&D executive director of Almirall, said: We are encouraged by these latest results, and we believe that the combination of LAS100977 with an already identified corticosteroid has the potential to become a best in class respiratory treatment. We look forward to announcing a partnership for the development and commercialization of this novel drug in 2009.