Biogen ( BIIB Quick Quote BIIB - Free Report) announced that its phase II study – TANGO – evaluating its anti-tau antibody, gosuranemab for treating Alzheimer’s disease, failed to meet its primary efficacy endpoint.
The primary endpoint of the study was change from baseline at week 78 on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) compared to placebo in patients with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s disease dementia. CDR-SB is a scale used to measure cognitive and functional performance of Alzheimer disease patients. A treatment benefit was not seen on exploratory efficacy endpoints.
Biogen has terminated the TANGO study and thereby development of gosuranemab.
Biogen’s shares have risen 59.8% this year so far against the
industry’s decrease of 0.7% in the same time frame. Image Source: Zacks Investment Research
The news comes only a few days after the FDA granted accelerated approval to Biogen and its partner Eisai’s controversial treatment for Alzheimer’s disease, Aduhelm (aducanumab).
Aduhelm has been approved to reduce the accumulation of amyloid beta plaques, a sticky protein, in the brain, which is believed to lead to progression of Alzheimer’s disease.
Aduhelm has become the first medicine to be approved to reduce the clinical decline associated with this devastating disease and targeting the underlying cause of the disease. It should bring in huge revenues for Biogen by meaningfully changing the course of Alzheimer’s treatment.
However, the controversial FDA decision has generated several headlines. Interestingly, the FDA approved Aduhelm despite an FDA advisory committee voting against its approval in November last year due to mixed outcomes data from ENGAGE and EMERGE phase III studies.
The FDA approval has faced a lot of criticism as some analysts believe the drug was not backed by strong evidence of efficacy. Aduhelm also comes with a hefty price tag of $56,000 a year, which has been widely condemned.
However, another group of analysts cheered the drug’s approval despite questionable study results because of the drug’s ability to remove amyloid from the brain and its potential to provide meaningful benefit in preventing progression of this disease
Alzheimer’s, a fatal condition that causes progressive decline in memory, has always been a highly challenging area, and not much progress has been made despite significant investments (both funds and resources). The drugs presently available just treat the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease. Several large pharma companies, including
Roche ( RHHBY Quick Quote RHHBY - Free Report) , Amgen ( AMGN Quick Quote AMGN - Free Report) , Novartis ( NVS Quick Quote NVS - Free Report) , Merck, Pfizer, Lilly and AstraZeneca stopped development of their AD candidates in the last few years either due to low possibility of success or safety concerns.
Despite the setbacks, the companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market.
Biogen currently carries a Zacks Rank #3 (Hold). You can see
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