Rigel Pharmaceuticals Down Sharply on wAIHA Treatment Trial Data
June 08 2022 - 8:22AM
Dow Jones News
By Michael Dabaie
Shares of Rigel Pharmaceuticals Inc. fell sharply after the
company said data from the Forward Phase 3 clinical trial of
fostamatinib in warm autoimmune hemolytic anemia, or wAIHA, didn't
demonstrate statistical significance in the primary efficacy
objective.
Shares fell 60% to 70 cents premarket Wednesday.
The company said the study didn't demonstrate statistical
significance in the primary efficacy endpoint of durable hemoglobin
response in the overall study population.
In a post-hoc regional analysis of U.S., Canadian, Australian,
and Western European trial sites, patients treated with
fostamatinib had a favorable durable hemoglobin response compared
with placebo, the company said. In the Eastern European trial
sites, patients didn't.
Rigel said it plans to continue analyzing the data to understand
the geographical differences in patient disease characteristics and
outcomes and discuss these findings with the U.S. Food and Drug
Administration.
The safety and tolerability profile in the Forward trial was
consistent with the existing fostamatinib safety database, the
company said.
Autoimmune hemolytic anemia is a rare, serious blood disorder in
which the immune system produces antibodies that lead to the
destruction of the body's own red blood cells. Warm antibody AIHA,
the most common form, is characterized by the presence of
antibodies that react with the red blood cell surface at body
temperature.
"While we are disappointed in the overall results, which were
impacted by a large placebo response rate from Eastern European
clinical sites, we are encouraged by the top-line results from the
U.S., Canada, Australia, and Western Europe. We continue to believe
fostamatinib has the potential to benefit patients with wAIHA, a
population with a serious unmet medical need," Chief Executive Raul
Rodriguez said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 08, 2022 08:07 ET (12:07 GMT)
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