Things are different this time around because TGD is taking specific action to ensure all of those catalysts are completed. Why do you think he is hiring all of these high-caliber people to his executive staff?
Reinforcing the Company’s commitment to drive value-creation through operational efficiencies and innovation in the industry, Anavex announces new additions to its leadership team with the appointment of Juan Carlos Lopez-Talavera, MD, PhD as Senior Vice President, Head of Research and Development, Terrie Kellmeyer, PhD as Senior Vice President of Clinical Development, and Jeffrey Edwards, PhD as Vice President of Clinical Pharmacology and Science.
We have 10 catalysts that are going to be executed very soon. TGD is doing the right thing by filling those positions now so they can prepare for their duties as each catalyst is executed.
(1) We’re encouraged by the very recently issued FDA guidance for early Alzheimer’s disease which states that one cognitive measure alone like ADAS-Cog could be a sufficient primary endpoint for early Alzheimer’s disease.
(2) We appreciate this new guidance and believe this opens another possible pathway for us to move forward in parallel to the initiated process of market authorization application to the European Medicine Agency, EMA, for blarcamesine for the treatment of Alzheimer’s disease which is already underway.
(3) Full data from the blarcamesine study in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal, (4) as well analysis of RNA sequencing of the trial is underway and interim data is expected by mid-2024.
(5) Concurrently, the ATTENTION-AD open-label extension trial is ongoing and we expect to be able to share interim data in the second half of 2024.
(6) In Rett syndrome, continued positive real-world evidence feedback from Rett syndrome patients and caregivers participating in the ongoing open-label extension trial and Compassionate Use Program for patients who participated in the EXCELLENCE trial encourages us to continue our partnership with the Rett syndrome community and to proceed with a Phase 3 12-week efficacy study. An educational presentation will be provided at the 2024 IRSF Rett Syndrome Scientific Meeting, taking place this year June 18, 2024 to June 19, 2024.
(7) Regarding Parkinson’s disease, initiation of an ANAVEX2-73 Phase 2b/3 six-month trial is expected in the second half of 2024.
(8) In Fragile X, new specific translatable and objective biomarker data generated with ANAVEX2-73 supporting the initiation of the potentially pivotal ANAVEX2-73 Phase 2/3 clinical trial will be presented at the 19th National Fragile X Foundation Conference taking place in July 25, 2024 to July 28, 2024.
(9) Related to a new rare disease, we are also in preparation to initiate a potentially pivotal ANAVEX2-73 Phase 2/3 trial.
(10) With respect to ANAVEX3-71, we are quite pleased to provide an update that the placebo-controlled Phase 2 clinical trial of ANAVEX3-71 for the treatment of schizophrenia. The study is well underway with the first cohort of schizophrenia patients being fully enrolled. We are also expecting further peer-reviewed clinical publications in both -- involving both ANAVEX2-73 and ANAVEX3-71.
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