Actinogen Medical announce the completion of a planned Interim Analysis of its Phase II XanADu trial by an independent Data Safety and Monitoring Board (DSMB), with the Company receiving the DSMB recommendation to continue the study without modification.
The DSMB recommendation affirms that the positive benefit-risk safety profile of Xanamem 10mg daily and supports the expectation that the study is progressing as planned. Importantly, no treatment-related serious adverse events have been reported. The outcome from the analysis supports the continuation of XanADu and the further development of Xanamem in other potential indications such as diabetes-associated cognitive impairment. The DSMB will conduct a follow-up meeting in three months’ time.
The Interim Analysis was conducted on the first 50 evaluable patients to have fully completed the study. An additional 37 patients’ safety data was also included in the analysis – this was data from patients still ongoing in the study.
XanADu is a randomized, double-blind, multi-centre clinical study comparing Xanamem to placebo in patients with mild dementia due to Alzheimer’s disease. The Interim Analysis was performed by the DSMB using prespecified assessments, outlined in the DSMB Charter and study Protocol, of unblinded safety and efficacy patient data on the first 50 evaluable patients. Based on the data reviewed, the independent DSMB has recommended that the XanADu study continue as planned without modification.
The XanADu patient data remains blinded to the Company and to all non-DSMB personnel involved in the clinical study including individual patients, clinical investigators, study site staff, and all contracted Company vendors. Blinded studies safeguard the integrity and credibility of clinical data and ensure that no biases are introduced.
Actinogen continues to enrol patients into the XanADu clinical trial and as 23rd May, a total of 100 patients have been enrolled, which is 57% of the total planned enrolment of 174 patients. The study continues to progress on track and in line with management’s projections, with the last patient expected to be enrolled by Q4 this year.
“We’re delighted with the recommendation from the DSMB to continue the trial without modification and it helps build our confidence and optimism in the potential of Xanamem to be an effective treatment for Alzheimer’s disease”, said Dr Bill Ketelbey, CEO of Actinogen Medical. “If Xanamem is shown to safely and effectively treat dementia due to Alzheimer’s disease, it would represent a significant breakthrough in the management of this devastating disease. We eagerly await the completion of the XanADu enrolment before the end of 2018 and the review of the full dataset in Q2 2019”, he continued.
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