TauRx Reports First Phase 3 Results for LMTX® - Seite 2

The same efficacy findings were not seen in study patients who took LMTX^® in combination with other standard Alzheimer's treatments. Since these patients formed the substantial majority of those recruited to the trial, the treatment benefits seen in those taking LMTX^® as monotherapy could not be seen when all patients taking LMTX^® were pooled in the primary analysis model. Although this prevented the study from achieving an overall statistical significance in the pooled analysis, the primary analysis model showed a highly significant effect of treatment in the patients taking LMTX^® as monotherapy. This treatment benefit was confirmed in a prespecified supportive analysis of all of the study's primary and secondary outcomes.  This is the first treatment in which a clinical effect has been supported by evidence in delay of progression in brain atrophy shown by MRI scans.

Professor Claude Wischik, Professor of Psychiatric Geratology at Aberdeen University and co-founder of TauRx said, "The results we have seen in this study confirm the results we saw in our Phase 2 study, where an earlier version of the drug was also given as monotherapy. The results we see in those patients not taking Alzheimer's disease medications show the considerable potential of LMTX^® as a monotherapy for both mild and moderate Alzheimer's disease. Perhaps more importantly, these results support the targeting of the tau tangle pathology in Alzheimer's disease as being a very promising drug development pathway.  However, the reason for the observed loss of efficacy of LMTX^® when taken in combination with currently available treatments for Alzheimer's disease is not as yet understood."  

An initial analysis of data from the second of TauRx's two Phase 3 trials in Alzheimer's disease, study TRx-237-005 undertaken in 800 patients with the mild form of the disease, confirms the findings of study TRx-237-015 and supports the potential of LMTX^® as monotherapy.  The results from this study are expected to be published and presented later in 2016.

Impact of LMTX^® Treatment on Key AD Measures

• The ADAS-cog decline analysis produced highly statistically significant treatment effects of -6.3 +/-1.4 (p<.0001) and -5.8 +/-1.4 (p<.0001) units after taking 75mg b.i.d or 125mg b.i.d of LMTX^® as monotherapy respectively, while the ADCS-ADL decline analysis produced a statistically significant treatment effect of 6.5 +/-1.8 (p=.0013) and 6.9 +/-1.9 (p=.0007) following treatment of 75mg b.i.d or 125mg b.i.d of LMTX^® as monotherapy respectively.
• LMTX^® taken as monotherapy also slowed down the rate of progression of brain atrophy as measured by LVV derived from MRI scans. There was a reduction in the expansion of the LVV by 38%+/-9% (p=.0023) and 33%+/-9% (p=.0014) for 75mg twice a day and 125mg twice a day, respectively, compared to the control in these patients.  These reductions in LVV expansion were statistically significant and confirmed by corresponding increases in the whole brain volumes in the same patient groups.
• In those study patients taking LMTX^® as add-on therapy to current AD medications, there were no statistically significant differences in ADAS-cog, ADCS-ADL or LVV measurements between the control, 75mg b.i.d LMTX^® or 125 mg b.i.d. LMTX^® treatment groups.

About Study TRx-237-015 

Study TRx-237-015, was a randomised double-blind placebo-controlled study in 891 subjects with mild or moderate Alzheimer's disease that compared treatment for 15 months with LMTX^® with placebo. The safety profile of LMTX^® in the study was acceptable, with rates of amyloid-related imaging abnormalities reported similar to placebo arms in recent Phase 3 trials and with the overall adverse event profile also similar to those typically seen in Phase 3 studies of novel late-stage Alzheimer's disease treatments. The most common adverse events occurred in the gastrointestinal and urinary tracts, and were typically mild in nature and easily controlled.