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Eisai and Biogen announced that patients with early Alzheimer's disease who received the highest dose of experimental drug BAN2401 experienced a 30% decline in clinical decline compared to placebo at 18 months . The data is certainly very interesting and promising, but investors remain wary about the design of the study and the unique criterion used to measure the effectiveness. Even the results obtained with the lower doses of the drug left some perplexities that only phase III will be able to dispel.
Eisai and Biogen announced that patients with early Alzheimer's disease received the highest dose of experimental drug BAN2401. they slowed the clinical decline by 30% compared to placebo by 18 months.
In addition, in the phase II study, the anti-amyloid beta antibody showed a dose-dependent reduction in amyloid plaques measured with amyloid PET, significant at all doses.
Lynn Kramer, Chief Medical Officer of The Neurological Domain of Eisai, commented "We believe that it is really the first of its kind" and "strong enough to be able to address the authorities of regulation to discuss next steps ".
However, Biogen's market share in post-market transactions fell by almost 12% from the peak achieved when results were anticipated, but no figures were yet known. Investors remain wary of the design of the study and the unique evaluation criteria used to measure the effectiveness. Even the results obtained with the lowest doses of the drug have puzzled that only Phase III will be able to dispel
The 201 randomized study 856 patients with mild cognitive impairment due to Alzheimer's disease or with mild Alzheimer's dementia with confirmed amyloid pathology in the brain. Patients received a dose of BAN2401 at 2.5 mg / kg every two weeks, 5 mg / kg every month, 5 mg / kg every two weeks, 10 mg / kg every month or 10 mg / kg every two weeks, or placebo
Last year, Eisai and Biogen stated that an independent data monitoring committee had established that the drug BAN2401 "did not meet the criteria for success" on the basis of an badysis for the main criterion of 12 months. , which uses the composite score developed internally by Eisai for Alzheimer's Disease (ADCOMS).
However, surprisingly, earlier this month companies announced that a final badysis of the study showed that the highest dose BAN2401 significantly slowed the clinical decline compared with placebo and reduces beta-amyloid in the brain.
More recently, Eisai and Biogen have announced that they will conduct Phase III testing for BAN2401.
The detailed results presented Wednesday at the International Conference of the Alzheimer's Association (AAIC) indicate that 253 patients received the dose BAN 2401. At 10 mg / kg per month, 161 received the drug at 10 mg / kg every two weeks, while another 253 received a placebo.
Eisai and Biogen add that following a regulatory application in 2014, the allocation of APOE4 carriers to the bi-weekly therapeutic group of 10 mg / kg was limited, resulting in a reduction of APOE4 carriers in this industry. and the badignment of more patients to the monthly therapeutic group of 10 mg / kg
The data showed that for the bi-weekly dose of 10 mg / kg, a significant deceleration of cognitive decline from baseline was observed. with the ADCOMS scale, which combines elements of the Scale of Assessment of Alzheimer's Disease – cognitive subscale (ADAS-Cog), the clinical sum of evaluation of dementia (CDR-SB) and the Mini-Mental State Examination (MMSE) is seen at six months, as well as at 12 months. Although patients treated with BAN2401 at 10 mg / kg per month showed some slowing of cognitive decline, the result was not significant.
Companies observed that the highest dose of BAN2401 also showed a significant slowdown. 47% of clinical decline measured by ADAS-Cog compared to placebo at six months and 18 months, but not at 12 months. Eisai and Biogen added that at 18 months, the decline in the clinical decline of the highest dose of BAN2401 treatment compared to placebo on CDR-SB was 26 percent, exceeding the pre-specified difference of 25 percent. hundred in the study
Other results showed that in patients who received BAN2401 10 mg / kg twice a week, an badysis of amyloid accumulated in the brain using a standardized PET measured on the Centiloid scale showed an observed average at 74.5 and 18 months away from 5.5. Eisai and Biogen explained that the reduction in average amyloid load was 70 units, which was significant, while in the higher dose group, 81% of patients switched from positive amyloid to erythromycin. amyloid negative at 18 months. 19659003] According to pharmacists, BAN2401 showed "an acceptable tolerability profile" for 18 months, with an incidence rate of 26.5% placebo-related adverse events for placebo, 53.4% for monthly treatment 10 mg / kg and 47.2% for the bi-weekly treatment group 10 mg / kg. The most common adverse events were amyloid-related imaging abnormalities (ARIA), with an incidence of 9.9% ARIA edema at the maximum dose of treatment
Michael Yee, a Jefferies badyst, noted that the key findings were consistent with expectations, but that "some aspects were mixed, as lower doses show worse results than a placebo."
In 2007, Eisai has obtained the exclusive worldwide license of BAN2401 from BioArctic. and jointly developed the drug with Biogen as part of a 2014 agreement focused on the treatment of Alzheimer's disease.
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