MedicalResearch.com Interview with:
Professor Claude Wischik
Co-Founder and Executive Chairman
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The study TRx-237-005 was the second of two Phase 3 trials conducted by TauRx, and was specifically set up to investigate the efficacy and safety of LMTX® in 800 patients with mild Alzheimer’s disease at a dose of 100 mg twice daily compared to 4 mg twice daily (intended as an inactive control dose) over an 18-month treatment period.
Results from this study were found to be consistent with those from the first Phase 3 study in mild to moderate Alzheimer’s disease, published in The Lancet [(TRx-237-015) Gauthier et al. 2016], indicating that patients obtained no benefit from LMTX® when it was taken in combination with existing approved drugs for Alzheimer’s disease and supporting the hypothesis that LMTX® might be effective as monotherapy at doses as low as 4 mg twice daily. Please refer to the press release for full study results.
MedicalResearch.com: What should readers take away from your report?
Response: Results of the second study showed the same significant differences in favour of LMTX® monotherapy on the co-primary clinical efficacy endpoints for the cognitive and functional outcomes. While the monotherapy subgroups in the two Phase 3 trials are small (15%-20%), the confirmation of the same pattern of results in the second independent trial means they are unlikely to be a chance finding. Also, while these results come from non-randomised cohort analyses, a number of things point to real treatment effects of LMTX® as monotherapy and not just differences between patients taking or not taking the existing approved drugs. In particular, the analysis showing a slow-down in the brain atrophy rate is a before-and-after analysis in which the monotherapy patients were their own controls, and so does not depend on a comparison with add-on therapy patients.
These findings strongly warrant further research – a part of the process of finding an effective treatment for patients diagnosed with Alzheimer’s disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The study results clearly indicate that a treatment that aims at the tau pathology underlying Alzheimer’s dementia may have therapeutic promise but that we cannot assume that simply combining treatments with different mechanisms of action will automatically provide a broader therapeutic effect. Further randomised controlled studies of LMTX® are set to commence shortly in which the 4 mg twice daily dose will be compared with placebo in patients with Alzheimer’s disease who are not receiving other approved treatments for this condition (cholinesterase inhibitors and/or memantine)
MedicalResearch.com: Is there anything else you would like to add?
Response: We would like to thank the patients and caregivers that took part in this study.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Potential of Low Dose Leuco-Methylthioninium Bis(Hydromethanesulphonate) (LMTM) Monotherapy for Treatment of Mild Alzheimer’s Disease: Cohort Analysis as Modified Primary Outcome in a Phase III Clinical Trial.
Wilcock GK1, Gauthier S2, Frisoni GB3, Jia J4, Hardlund JH5, Moebius HJ6, Bentham P7, Kook KA8, Schelter BO9, Wischik DJ10, Davis CS11, Staff RT12, Vuksanovic V12, Ahearn T12, Bracoud L13, Shamsi K14, Marek K15, Seibyl J15, Riedel G16, Storey JMD5,17, Harrington CR5,16, Wischik CM5,16.
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