AZD7624 / AstraZeneca - LARVOL DELTA

Differential anti-inflammatory effects of budesonide and a p38 MAPK inhibitor AZD7624 on COPD pulmonary cells (ERS 2018) - "These findings support theuse of multiple anti-inflammatory strategies in COPD. This study was supportedby AstraZeneca."

Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology

Differential anti-inflammatory effects of budesonide and a p38 MAPK inhibitor AZD7624 on COPD pulmonary cells. (PubMed, Int J Chron Obstruct Pulmon Dis) - "We observed variable corticosteroid and p38 MAPK inhibitor anti-inflammatory responses within the same individual depending on the cell type studied. These findings support the use of multiple anti-inflammatory strategies in COPD patients due to differences between cell types."

Journal • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology

Effects of p38 Inhibitor AZD7624 in Corticosteroid Resistant Asthma (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: National Jewish Health; Not yet recruiting ➔ Recruiting; Trial primary completion date: Jan 2017 ➔ Jan 2018

Enrollment open • Trial primary completion date • Asthma • Biosimilar • Immunology

A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy (clinicaltrials.gov) - P2a; N=213; Completed; Sponsor: AstraZeneca; N=326 ➔ 213

Enrollment change • Biosimilar • Chronic Obstructive Pulmonary Disease • Immunology

Does Z' equal 1 or 2? Enhanced powder NMR crystallography verification of a disordered room temperature crystal structure of a p38 inhibitor for chronic obstructive pulmonary disease. (PubMed, Phys Chem Chem Phys) - "The crystal structure of the Form A polymorph of N-cyclopropyl-3-fluoro-4-methyl-5-[3-[[1-[2-[2-(methylamino)ethoxy]phenyl]cyclopropyl]amino]-2-oxo-pyrazin-1-yl]benzamide (i.e., AZD7624), determined using single-crystal X-ray diffraction (scXRD) at 100 K, contains two molecules in the asymmetric unit (Z' = 2) and has regions of local static disorder...Of the CSP-generated structures, 2 are found to be fully consistent with the SSNMR and pXRD data; within this pair, they are found to be structurally very similar (RMSD16 = 0.30 Å). We establish that the CSP structure in best agreement with the NMR data possesses the highest degree of structural similarity with the scXRD-determined structure (RMSD16 = 0.17 Å), and has the lowest DFT-calculated energy amongst all CSP-generated structures with Z' = 2."

Journal • Biosimilar • Chronic Obstructive Pulmonary Disease

AstraZeneca to present data demonstrating diversity of its portfolio of innovative formulations and devices at the European Respiratory Society International Congress 2015 (Benzinga) - "Highlights from AstraZeneca's early respiratory portfolio to be presented include: Data on the company's inhaled p38 inhibitor (AZD7624), aimed at delivering a broad anti-inflammatory effect in COPD patients..."

Anticipated clinical data • Chronic Obstructive Pulmonary Disease

AZD7624, an inhaled p38 inhibitor, demonstrate local lung inhibition of LPS-induced TNFα with minimal systemic exposure. (PubMed, J Pharmacol Exp Ther) - "Thus, a mean unbound AZD7624 plasma concentration of 0.3 nmol/L, which was associated with a decrease in LPS-induced sputum TNFα by 85%, is much lower than the pIC50u. This demonstrates that AZD7624 can achieve significant local lung pharmacodynamic effects concomitant with sub pharmacological systemic exposure."

Journal

Effects of p38 Inhibitor AZD7624 in Corticosteroid Resistant Asthma (clinicaltrials.gov) - P2; N=2; Completed; Sponsor: National Jewish Health; N=30 ➔ 2

Enrollment change

Effects of p38 Inhibitor AZD7624 in Corticosteroid Resistant Asthma (clinicaltrials.gov) - P2; N=30; Completed; Sponsor: National Jewish Health; Recruiting ➔ Completed; Trial completion date: Jan 2018 ➔ Feb 2019; Trial primary completion date: Jan 2018 ➔ Feb 2019

Trial completion • Trial completion date • Trial primary completion date