Shares of Rigel Pharma RIGL have plunged more than 30 percent Thursday following news from its development partner AstraZeneca AZN that fostamatinib achieved its primary endpoint but failed to achieve the secondary endpoint. Volume in Rigel is very heavy Thursday.
AstraZeneca today
announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of
fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen
tyrosine kinase) in development as an oral treatment for rheumatoid arthritis
(RA).
OSKIRA-4 was a six month study evaluating improvements in signs and symptoms
of RA in 280 patients who had never previously used a disease-modifying
anti-rheumatic drug (DMARD), were DMARD intolerant or had an inadequate
response to DMARDs and were randomised to receive fostamatinib as a
monotherapy, adalimumab as a monotherapy, or placebo. Three dose regimens of
fostamatinib were evaluated in OSKIRA-4: 100mg twice daily, 100mg twice daily
for a month followed by 150mg once daily, and 100mg twice daily for a month
followed by 100mg once daily.
OSKIRA-4 had two primary objectives – a superiority comparison to placebo at 6
weeks and a non-inferiority analysis against adalimumab monotherapy at 24
weeks as measured by change from baseline in DAS28 score (a composite endpoint
assessing signs and symptoms of RA).
In the OSKIRA-4 study, fostamatinib as a monotherapy met the first primary
objective, showing a statistically significant superior DAS28 score change
from baseline compared to placebo at 6 weeks at the 100mg twice daily dose and
the 100mg twice daily for a month followed by 150mg once daily dose, but not
at the 100mg twice daily for a month followed by 100mg once daily dose.
The OSKIRA-4 study did not meet its second primary objective as all
fostamatinib monotherapy doses were inferior to adalimumab monotherapy at week
24 based on DAS28. The adalimumab monotherapy ACR20 result at the 24 week
endpoint was 59%.
The safety and tolerability findings for fostamatinib as reported in the
OSKIRA-4 study were generally consistent with that previously observed in the
TASKi Phase II programme.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in