On July 22, 2015, Biogen (BIIB) released data from a Phase 1b study, also called the PRIME study, that looked at the effectiveness of its investigational Alzheimer’s drug, BIIB037. As explained in the previous article in this series, PRIME is an ongoing Phase 1b randomized, double-blind, placebo-controlled study. In this study, patients are tested with dosages of varying strength to evaluate the efficacy of the drug.
The above graph shows the efficacy of the various dosages of BIIB037 as compared to the placebo, measured on the Mini Mental State Examination, or MMSE, scale. ClinicalTrials.gov defines a placebo as “A substance that does not contain active ingredients and is made to be physically indistinguishable (that is, it looks and tastes identical) from the actual drug being studied. In placebo-controlled study, patients receiving the new treatment are compared with those which receive a placebo.”
According to the Alzheimer’s Society, “The Mini Mental State Examination (MMSE) is the most commonly used test for complaints of problems with memory or other mental abilities. It can be used by clinicians to help diagnose dementia and to help assess its progression and severity.”
Patients who were administered a placebo registered a decline of 2.81 MSME points in cognition skills. Those who were given BIIB037 at a rate of 1 mg (milligrams), 3 mg, 6 mg, and 10 mg per kilogram of their body weight registered a decline in MSME points of 2.18, 0.7, 1.96, and 0.56, respectively. According to Biogen, the difference in results was statistically significant only for 3 mg and 10 mg dosages.
Dementia rating results
The above graph shows the efficacy of the various dosages of BIIB037 as compared to a placebo, measured according to a Clinical Dementia Rating sum of boxes, or CDR-SB, scale. According to the Alzheimer’s Disease Research Center at Washington University in St. Louis, “The Clinical Dementia Rating or CDR was developed at the Memory and Aging Project at Washington University School of Medicine in 1979 for the evaluation of staging severity of dementia. It was developed primarily for use in persons with dementia of the Alzheimer type (the equivalent of probable Alzheimer’s Disease) and it can also be used to stage dementia in other illnesses as well.”
Patients who were administered a placebo registered a cognition-skills decline of 1.87 CDR-SB points. Those who were given BIIB037 at a rate of 1 mg, 3 mg, 6 mg, and 10 mg per kilogram of their body weight registered a decline in CDR-SB points of 1.72, 1.37, 1.11, and 0.63, respectively. According to Biogen, the difference in results was statistically significant only for the 10 mg dosage.
At the end of the day, the results indicate that Biogen’s Alzheimer’s drug is effective in reducing cognitive decline when higher dosages are administered to patients. This has dampened the investor interest in the drug, as a majority had expected that the 6 mg dosage or the middle dose would be more effective in treating Alzheimer’s patients.
Biogen’s BIIB037 is a novel therapy that aims to cure Alzheimer’s disease. Other medications currently available in the market such as Allergan’s (AGN) Namenda, Pfizer’s (PFE) Aricept, and Novartis’s (NVS) Exelon only help in reducing the severity of Alzheimer’s symptoms. So if approved, BIIB037 will be a breakthrough therapy in the Alzheimer’s market.
You can get exposure to Biogen’s new Alzheimer’s therapy, BIIB037, while avoiding company-specific risks by investing in the iShares NASDAQ Biotechnology ETF (IBB). IBB has 7.48% of its total holdings in Biogen.