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news.Maryland, US-based drug maker MedImmune has started dosing patients in a multi-dose, Phase Ib clinical trial of MEDI-545, its monoclonal antibody targeting interferon-alpha. The study is designed to evaluate the safety and tolerability of multiple doses of MEDI-545 in patients with systemic lupus erythematosus, a chronic inflammatory disease.
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In a press release, MedImmune said that the trial is the third clinical study of the antibody currently underway. MEDI-545 is also being evaluated in a single-dose Phase I trial in lupus patients and a Phase I study in patients with psoriasis.
The Phase Ib trial will build on preliminary data from the ongoing Phase I study in lupus patients. Early results from the single-dose trial show an acceptable safety profile and tolerability of MEDI-545.
In addition to advancing MEDI-545 as a potential treatment for lupus, MedImmune has recently expanded the anti-interferon-alpha program to include other potential disease areas. As well as the Phase I trial in patients with psoriasis that was initiated earlier in 2007, MedImmune plans to begin a trial in idiopathic inflammatory myopathies later this year.
“This multi-dose study marks an important milestone in MedImmune’s efforts to develop innovative treatments for inflammatory diseases such as lupus,” said Barbara White, vice president, clinical development, inflammatory disease at MedImmune.