Almirall and Forest’s phase III COPD drug misses goal
pharmafile | November 3, 2010 | News story | Research and Development | Aclidinium bromide, Almirall, COPY, Forest, Forest Laboratories, chronic obstructive pulmonary disease
Almirall and Forest’s COPD drug aclidinium bromide has disappointed in a phase III trial by producing fewer benefits than found in earlier studies.
In the 12-week trial conducted on 544 patients, twice-daily aclidinium bromide did seem to help patients. However, for the expected therapeutic dose, 400 ug, the magnitude of effect compared with placebo was less than that observed in previous phases.
Almirall and Forest Laboratories are co-developing the drug, which they hope could challenge the big sellers in the market like GSK’s Seretide and Boehringer Ingelheim/Pfizer’s Spiriva.
Per-Olof Andersson, executive director of R&D at Almirall, remained positive: “We believe aclidinium bromide has the potential to be an important treatment option for the millions of COPD patients suffering with this debilitating disease.”
Alclidinium bromide is a long-acting investigational anticholinergic bronchodilator, which has a long residence time at the M3 receptors and a shorter residence time at the M2 receptors. Aclidinium is rapidly hydrolysed in human plasma to two major inactive metabolites.
The results of this trial, the second of three double-blind placebo-controlled studies, are disappointing because new treatment options are needed to help tackle COPD, which remains impossible to cure or even to halt in its progression.
Lawrence Olanoff, president and chief operating officer of Forest Laboratories, added: “We remain confident that the ongoing phase III ATTAIN trial will confirm a clinical effect of aclidinium BID similar to that as reported in January of this year for the ACCORD COPD I trial and the phase II comparison studies.”
Brett Wells
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