Chiesi reports successful completion of Phase 2 Proof of Concept study
Chiesi reports successful completion of Phase 2 Proof of Concept study with novel inhaled PDE4 inhibitor.
Parma, Italy, — October 1st, 2013 - Chiesi Group announces that it has successfully completed a Phase 2 Proof of Concept trial of its inhaled PDE4 (phosphodiesterase 4) inhibitor, denoted CHF6001, a new chemical entity developed for the treatment of inflammatory respiratory disorders, such as chronic obstructive pulmonary disease (COPD) and asthma.
The purpose of this clinical study was to evaluate the efficacy and safety of two doses of CHF6001 (400µg and 1200µg) in attenuating bronchoconstriction induced by allergen challenge in patients with mild asthma. Thirty six steroid-naïve, allergic asthmatic patients were enrolled in the double-blind, placebo-controlled randomized, cross-over trial and received both doses of CHF6001 or placebo once daily for 9 days. Both doses of CHF6001 resulted in a significant attenuation of the late asthmatic response (the primary endpoint) accounting for a reduction by 20% and 30% over placebo respectively for the 400µg and 1200µg doses. A trend in the reduction of sputum inflammatory cells as compared to placebo was observed with both doses. Both doses were safe and well tolerated particularly with respect to gastrointestinal disorders, a limiting side effect for many PDE4 inhibitors. These data with CHF6001 confirm the anti-inflammatory activity positive safety safe profile demonstrated in pre-clinical studies of the compound.
About CHF 6001
CHF 6001 is a novel selective PDE4 inhibitor, optimized for inhaled delivery to improve efficacy and tolerability. The anti-inflammatory activity of CHF 6001 has been proven in vitro and in several animal models of airway inflammation, showing higher potency than the marketed oral PDE4 inhibitor (roflumilast, Daxas/Daliresp by Takeda) and more targeted anti-inflammatory effects than corticosteroids in COPD models. The compound is characterized by a low oral bioavailability, inactive metabolites, high plasma protein binding, low plasma/lung concentration ratio and low brain exposure. Moreover, CHF 6001 was very well tolerated in extended pre-clinical safety studies and the safety margin between the anti-inflammatory action and side-effects (such as nausea and emesis) was much larger in comparison to oral and inhaled PDE4 inhibitors developed to date.
The doses achievable in humans with most PDE4 inhibitors are limited by side effects, and therefore the optimal therapeutic effects of this class of drug have never been achieved. The profile of CHF 6001 indicates that it will not be under-dosed in humans to achieve an acceptable side effect profile, supporting its high potential for the treatment of COPD and asthma.
About Chiesi Group
Founded in 1935 in Parma, Italy, Chiesi Farmaceutici currently has 25 affiliates worldwide and markets its therapeutics in over 60 countries. Chiesi's manufacturing plants in Parma, Blois (France) and Santana de Parnaiba (Brazil), and R&D centers in Parma, Paris, Rockville (USA) and Chippenham (UK) integrate their efforts to advance the Group's pre-clinical, clinical and registration programs. At the end of 2012, the Chiesi Group's total staff stood at over 3,800 people, more than 350 of whom are dedicated to R&D.
The main areas of activity are in respiratory therapeutics and specialist medicine areas. A clear shift occurred in the last years towards more innovative molecules. The respiratory pipeline now comprises several classes of novel bronchodilating agents (Long acting muscarinic antagonists, bifunctional muscarinic antagonists-Βeta2 Agonits) and anti-inflammatory agents (PDE4 inhibitors, p38 kinase inhibitors, Neutrophil elastase inhibitors) that provide opportunities for future innovative fixed combinations for the treatment of asthma and COPD.
Posted: October 2013