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23 Oct 2019
Biogen Update on Aducanumab Likely to have a Major Impact on Sector re-rating, with Strong Read Across for LupuzorTM
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Biogen Update on Aducanumab Likely to have a Major Impact on Sector re-rating, with Strong Read Across for LupuzorTM
ImmuPharma plc (IMM:LON) | 2.1 0 (-2.5%) | Mkt Cap: 8.85m
- Published:
23 Oct 2019 -
Author:
Dr. Navid Malik -
Pages:
4
Yesterday, Biogen made a significant announcement for its shareholders and the broader sector alongside a strong set of Q3 results. Biogen announced that its Alzheimer’s drug, Aducanumab (monoclonal antibody), which it had been developing for early stage Alzheimer’s disease, and that had recently failed two Phase III (named: ENGAGE and EMERGE) clinical trials for futility (announced in March 2019), had gone on to demonstrate a strong signal of efficacy. In a subgroup of patients who elected to continue treatment at a higher dose, allowing sufficient exposure to the drug, it was clearly demonstrated that Aducanumab was able to achieve a statistically significant reduction of clinical decline in early Alzheimer’s Disease patients in a study called EMERGE (Biogen also stated that it believes that a sub-group of patients in ENGAGE also support the positive data seen). This is the first time that in the history of Alzheimer’s drug development, that a clinical study has demonstrated this type of effect. Further analysis of the ENGAGE study for Biogen does, we believe, potentially demonstrate a strong read-across for Lupuzor™, wherein Lupus patients who were ds-DNA positive (a sub-group – of European patients) and who were given Lupuzor™, a statistically and clinically meaningful reduction in Lupus disease symptoms were seen. Biogen believes that the lessons learnt from the EMERGE trial (with Aducanumab) could have positive implications for a number of other trials that the company is conducting in indications such as Tau-targeted Alzheimer’s, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). The receptiveness of the FDA in advice to Biogen, to file for regulatory approval for its Alzheimer’s drug Aducanumab, is a clear signal that regulators are willing to be pragmatic about how they assess clinical data from ‘failed’ trials in diseases where there is a significant unmet or poorly met medical need. We continue to expect positive updates from ImmuPharma from its pipeline and reiterate our BUY rating and a Target Price of 76p.