AZ, Sanofi discontinue RA, lung cancer drug trials

AstraZeneca has decided not to pursue regulatory filings of its investigational rheumatoid arthritis drug, fostamatinib, following disappointing phase 3 clinical trial results. Fostamatinib is the first oral spleen tyrosine kinase (SYK) inhibitor in development as an oral treatment for rheumatoid arthritis (RA).

“The results of the late stage trials did not measure up to the promising results we saw earlier in development. We remain committed to the search for new treatments for patients with rheumatic and inflammatory diseases with Phase II compounds in rheumatoid arthritis and lupus and Phase III compounds in gout and psoriasis.”
Briggs Morrison, MD, Executive Vice President of Global Medicines Development and Chief Medical Officer.

AstraZeneca will return the rights to the compound to Rigel Pharmaceuticals which will decide whether it will continue the ongoing studies and pursue regulatory filings.

Meanwhile, Sanofi has also announced the discontinuation of phase 3 clinical trials of two investigational non-small cell lung cancer drugs, iniparib and otamixaban.

The phase 3 ECLIPSE trial of iniparib in squamous non-small cell lung cancer (Sq NSCLC) did not meet its primary endpoint. In the study, newly diagnosed, metastatic Sq NSCLC patients treated with iniparib plus chemotherapy did not achieve improvement in overall survival compared to patients who received chemotherapy alone. Following these findings, Sanofi has decided to terminate the internal development program and as a consequence will take a US $285 million charge.

Development of otamixaban will also be halted after the investigational anticoagulant did not meet its primary endpoint of superiority over current therapy.


Related news:

AstraZeneca drops Rigel rheumatoid arthritis pill (Reuters)

Sanofi Ends Iniparib Research, to Take $285 Million Charge (3) (Bloomberg News)

Reference links:

Sanofi press release

AstraZeneca press release

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