Biogen Reports Top-Line Results from Phase 2 Study in Progressive Supranuclear Palsy
CAMBRIDGE, Mass., Dec. 13, 2019 (GLOBE NEWSWIRE) -- Today, Biogen Inc. (Nasdaq: BIIB) announced topline results from the Phase 2 PASSPORT study of gosuranemab (BIIB092) for progressive supranuclear palsy (PSP). The primary endpoint, as measured by the PSP rating scale (PSPRS) at week 52, was not statistically significant. In addition, the study did not demonstrate efficacy on key clinical secondary endpoints. Based on these results, Biogen will discontinue development of gosuranemab for PSP and other primary tauopathies.
“We are disappointed with the efficacy results of the Phase 2 PASSPORT study,” said Alfred Sandrock Jr., M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer at Biogen. “We remain unwavering in our commitment to advancing therapies that have the potential to address the significant unmet medical needs of people with neurodegenerative diseases who are faced with limited to no treatment options.”
Safety results of the PASSPORT study were generally consistent with previous studies of gosuranemab. Detailed results of this study will be made available in a future scientific forum.
Biogen will continue its ongoing Phase 2 TANGO study of gosuranemab for mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD, given differences in disease pathology.
TANGO, a Phase 2 study, is designed to evaluate the safety and tolerability of gosuranemab in participants with mild cognitive impairment due to Alzheimer’s disease or with mild Alzheimer’s disease.
Biogen licensed gosuranemab from Bristol-Myers Squibb Company.
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Biogen Safe Harbor Statement
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of gosuranemab; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including gosuranemab; the occurrence of adverse safety events; the risks of other unexpected hurdles, costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this news release.
We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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