4th Apr 2019 11:26
LONDON (Alliance News) - AstraZeneca PLC on Thursday posted strongly positive results from a phase two study of Fasenra in patients with hypereosinophilic syndrome, including a near-complete depletion of eosinophils in some patients.
Hypereosinophilic syndrome is the name for a group of rare disorders in which a person has too many eosinophils - white blood cells - in their blood and tissues. These eosinophils damage organs and can be fatal without treatment, producing symptoms such as fatigue, asthma, breathing difficulties, and arthritis.
In the randomised trial phase of the study, 90% of patients taking the drug experienced a drop in absolute blood eosinophil count of 50% or more after 12 weeks. The same drop was only seen in 30% of patients taking a placebo.
In the open-label phase of the trial, 74% of patients taking Fasenra maintained their reduced blood eosinophil count and had improved symptoms through week 48.
Of these, 64% proved able to taper their background medicines for hypereosinophilic syndrome. Taking tissue biopsies from such patients found an almost complete depletion of eosinophils.
The three most common adverse events for patients taking Fasenra were headaches, chills, and an elevated concentration of the enzyme lactate dehydrogenase. Higher levels of these enzyme were seen after the first dose and resolved in 48 hours.
At present, Fasenra is approved as an add-on maintenance treatment for severe, eosinophilic asthma in a number of countries, including the US and Japan, as well as in the EU. Orphan drug designation was granted to Fasenra in the US in February as a treatment for hypereosinophilic syndrome.
Shares in Astra were down 0.7% at 6,121.00 pence on Thursday.
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