Biogen and UCB’s lupus drug achieves primary objective in late-stage trial

Biogen and UCB have published a listing of a late-stage clinical trial of dapirolizumab pegol, an experimental drug for treating lupus, a disease in development for over twenty years. The drug, when administered together with the current first line therapy, lowered disease activity compared to a sugar pill in a group of SLE patients, the common type of lupus.

The study recruited 321 patients with moderate to severe disease and assessed them up to week 48. The drug had earlier flunked in a mid-stage trial in 2018 and many believe that these outcomes could open up the possibility of a new therapy for lupus sufferers.
Lupus is an autoimmune disorder that mostly affects females, causes inflammation of the body tissues and can cause the failure of the vital organs. Lupus does not have many treatment methods with approved drugs being corticosteroids, Saphnelo by AstraZeneca, Benlysta by GSK. Recent years have seen advances made in the way of treating lupus but there is still much scope for further improvement in the treatment of this disease. Adam Myers, Biogen’s head of immunology, argued that many drugs for lupus are not very effective and many drugs have a slow action time and Biogen wants to offer better options.
Earlier, Biogen and UCB put the let down to some of the scientific factors like bad protocol design to include patients with mild CPL since the exclusion of patients with them perform worse and not standardizing background steroid use. By varying these parameters and targeting sicker patients, the companies are convinced that they have provided a more convincing case for the product. Furthermore, the results showed that the rates of additional secondary outcomes that defined disease activity and flare-ups were significantly enhanced as well. Safety outcomes were comparable to previous phases with no significant adverse reactions to the drug.

Specific information from this study has not been published but will be disclosed during another medical conference. The companies are, however, intending to conduct a second massive trial to meet the stringent regulatory requirements of the efficacy and safety of the drug. If the same is achieved, the drug could be seen as another option in an area of medicine where most treatments have been disappointing in trials. Biogen and UCB are also exploring other lupus drugs, such as litifilimab that place them as key players in the fight against this challenging autoimmune disease.

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