MedImmune's asthma drug enters Ph II and Ph I

US drugmaker MedImmune says it has advanced the development of CAT-354, its potential treatment for asthma, with the start of two new trials. One of the studies of the interleukin-13 monoclonal antibodyis a Phase II evaluation in Europe and Australia designed to assess the potential of the anti-IL-13 drug in patients with uncontrolled asthma despite optimal treatment. The company has also begun dosing patients in the first USA-based clinical trial of the agent, a Phase I study to assess pharmacokinetics in healthy adults.

The Phase II clinical trial is designed to assess the effects of CAT-354 on airway hyper-responsiveness in patients with uncontrolled asthma. The first Phase I trial of CAT-354 in the USA is designed to compare its pharmacokinetics when administered via subcutaneous injection versus intravenous infusion in healthy patients. This randomized, open-label, study in healthy male patients marks the first clinical trial to assess the subcutaneous administration of CAT-354, as previous studies have used intravenous infusion administration.

According to the firm, which is a wholly-owned unit of Anglo-Swedish drug major AstraZeneca, early preclinical data have shown the potential of the recombinant human IL-13 monoclonal antibody to treat varying degrees of asthma. The effects of CAT-354 have been investigated in in vitro and in vivo systems and Phase I data in mild-to-moderate asthmatic volunteers demonstrated the safety and tolerability of the monoclonal antibody, thus supporting its continued development.