Date: 2012-06-06
Type of information:
phase: 2
Announcement: results
Company: Almirall (Spain)
Product: abediterol
Action mechanism: Abediterol is a long-acting ?2-agonist (LABA). It was delivered in Almirall’s multidose dry powder inhaler Genuair®.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Respiratory diseases
Country:
Trial details:
Latest
news: Almirall has announced the positive results of a single dose study where abediterol once a day (OD), delivered in the Genuair® inhaler provided significantly greater bronchodilation when compared with indacaterol and placebo in chronic obstructive pulmonary disease (COPD) patients. Abediterol once-daily in fixed dose combination with an inhaled corticosteroid is now ready to move into Phase IIb clinical development worldwide for asthma and COPD. Pharmacokinetic and drug-drug interaction studies on the abediterol/ICS fixed dose combination in man have also been conducted and recently finalized. Almirall is now focusing on a value development plan for the ex-USA territories that should enable a rapid market entry in this expanding therapeutic area. The company is evaluating partnering alternatives to enhance the development and commercialisation of this new respiratory treatment. The study complements a comprehensive Phase IIa program where different doses of abediterol demonstrated a fast onset (five minutes after the first administration for most of the doses tested) and long-lasting (24-hour) efficacy profile (p<0.001, trough FEV1 [23h-24h] after single doses of abediterol above 0.625µg) compared to placebo. Abediterol also showed a good safety and tolerability profile in patients with mild to moderate persistent asthma after multiple dosing (incidence of treatment-emergent adverse events with the abediterol dose of 10µg -after 7 days- was comparable to placebo [50% vs 46.7% respectively]). In addition, abediterol (5, 10 and 25µg doses) demonstrated clinically and statistically significant improvements in trough FEV1 in a head to head comparison vs salmeterol Accuhaler® 50µg BID (p<0.001) in a single-dose cross over treatment study in stable persistent asthmatic patients.
In this Phase IIa study, change from baseline in trough FEV1 following a single dose administration of a range of abediterol doses below 10µg once daily showed a statistically significant improvement vs placebo (p<0.001 for all abediterol doses) and, also, vs indacaterol 150µg (p<0.001 for abediterol doses of 2.5, 5 and 10µg). These comparative results reinforce abediterol as a new once-daily long acting ?2 agonist (LABA) that potentially provides added bronchodilation effect when compared to indacaterol, the only OD LABA currently in the market.
