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|Positive Top-Line Results Achieved From Two Phase 1 Clinical Trials of BACE Inhibitor BI1181181/VTP-37948 in Alzheimer's Disease|
The single rising dose trial assessed the safety, tolerability and pharmacokinetic profile of BI1181181/VTP-37948. In the study, BI1181181/VTP-37948 was safe and generally well-tolerated across all dose levels tested. Also, the results indicated a half-life of between 16 and 19 hours, supporting a once-daily dosing profile.
In the proof of mechanism trial, intermediate doses of BI1181181/VTP-37948 were assessed for the potential to reduce amyloid beta (Aβ) levels in cerebral spinal fluid (CSF). Plaques of amyloid beta in the brain are one of the primary indicators of Alzheimer's disease. In this trial, BI1181181/VTP-37948 demonstrated the ability to lower CSF Aβ levels by more than 80%.
Based on the results of both of these trials, Boehringer Ingelheim expects to initiate additional Phase 1 studies, including a multiple rising dose trial which is expected to complete in the first half of 2015.
"To the scientists, the amyloid beta reduction observed with BI1181181/VPT-37948 provides early, but encouraging, insights into its potential to demonstrate clinical efficacy," said Dr.
About Alzheimer's Disease
Alzheimer's disease is the most common type of dementia and is increasing in prevalence as the population ages. According to the
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Safe Harbor Statement
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the clinical development of BI1181181/VTP-37948. In some cases, you can identify forward-looking statements by terms such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "target," "design," "estimate," "predict," "potential," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties and may turn out to be wrong. For example, our statements about the timing and conduct of further clinical trials could be affected by the potential that we identify serious side effects or other safety issues, the fact that we are developing BI1181181/VTP-37948 as part of a collaboration and relying on a third party to conduct the trials and the other inherent risks of clinical development. Furthermore the results of preclinical and clinical trials conducted to date may not be predictive of future results. Vitae's product candidates are at an early stage of development and contain a high level of development risk. All of our forward looking statements are subject to risks detailed in our filings with the