Roche Holding AG RHHBY announced that it is discontinuing two phase III studies on the investigational anti-beta-amyloid molecule, crenezumab in people with early (prodromal to mild) sporadic Alzheimer’s disease (AD). The company made this decision based on the results from a pre-planned interim analysis that indicated that crenezumab was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
The interim analysis was conducted by the Independent Data Monitoring Committee (IDMC). The two late-stage studies — CREAD 1 and CREAD 2 — were evaluating the efficacy and safety of crenezumab in 1,500 early AD patients with confirmed evidence of cerebral beta amyloid pathology (CSF or amyloid PET). These studies used doses four times higher than that in the phase II studies.
Roche stated that an Alzheimer's Prevention Initiative (API) study of crenezumab in familial Alzheimer's disease will continue, and so will late-stage GRADUATE studies with gantenerumab and mid-stage TAURIEL study with the anti-tau molecule, RG6100.
Crenezumab is being developed by Roche in collaboration with Swiss biotechnology company, AC Immune SA ACIU. Shares of AC Immune went down about 34.6% in pre-market, following the news. Shares of Roche have increased 7.4% in the past year, against the industry’s decline of 1.2%.
Alzheimer’s, a fatal illness that causes progressive decline in memory, has always been a highly challenging area, with not much progress being made in spite of significant investments (both funds and resources). Several companies have failed to develop safe and effective treatment options for this deadly brain disease.
Lilly has had its share of failures in AD. In June 2018,Lilly discontinued two late-stage studies on its AD candidate,lanabecestat on the recommendation of the IDMC.
Among other companies, in May 2018, J&J JNJ halted the development of atabecestat, its investigational BACE inhibitor, which was being developed for pre-clinical stage Alzheimer’s disease, due to safety concerns.
In February 2018, Merck MRK discontinued the second late-stage study evaluating its BACE inhibitor verubecestat for the treatment of prodromal Alzheimer’s disease, as its success was unlikely.
Despite the setbacks, companies continue to invest heavily in developing Alzheimer’s disease treatments, given the high commercial potential in the market. Success in this area means huge returns. The market has immense commercial potential, and companies coming out with new treatments could rake in billions of dollars.
Roche currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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