Cambridge, UK, 28th March 2023 – TRx Biosciences today announces that Monument Therapeutics, a stratified neuroscience company, will be presenting positive results from their lead clinical program, MT1980, at the AD/PD conference, March 28th–April 1st 2023. MT1980

In this presentation, Monument Tx will report data from their first-in-human Phase I study of MT1980, an anti-inflammatory compound using novel brain-targeting technology developed by TRx Biosciences. Healthy volunteers received either placebo or a single oral dose of MT1980 at 70mg, 140mg or 250mg to evaluate safety and tolerability, systemic bioavailability, and presence of the drug in cerebrospinal fluid (CSF). MT1980 was very well tolerated without any significant side effects or other safety signal identified. Drug was found in the CSF for all of the volunteers, indicating presence of the drug in the brain for each dose level of MT1980.

MT1980 has been designed as an innovative therapy for poorly-treated conditions associated with neuroinflammation, such as Alzheimer’s disease, post-operative cognitive decline and long Covid. The unique absorption profile of MT1980, achieved using technology developed by TRx Biosciences and exclusively licensed to Monument Tx, resolves blood-brain-barrier penetration limitations that exist with standard on-market formulations of the compound. In preclinical studies reported in 2022, MT1980 showed significantly enhanced brain uptake and strong anti-neuroinflammatory activity across a panel of key biomarkers.

Monument Therapeutics now plans a further Phase I clinical study to rapidly provide additional safety and pharmacokinetic data following multiple dosing of MT1980, in addition to evidence of an anti-inflammatory effect in the brain.

Kiri Granger, Chief Scientific Officer of Monument Therapeutics, said:

“Our first clinical study demonstrates we have a unique opportunity to exert multiple attractive anti-inflammatory pharmacologies within the brain using MT1980 without significant side effects. This brings Monument one step closer to treating many patients experiencing symptoms such as memory loss and cognitive problems as a result of inflammation in the brain who are currently under-served.  We are very excited to continue this work by showing how the presence of our compound in the brain delivers efficacy in a human model of neuroinflammation.”

John Brew, Chief Scientific Officer of TRx Biosciences added:

“TRx is delighted to be collaborating with Monument on MT1980.  Our oral delivery technology uniquely enables drug delivery to the CNS, creating the potential for centrally penetrant anti-inflammatory effects.”

Jenny Barnett, Chief Executive Officer of Monument Therapeutics added:

“We are delighted to present detailed data from Monument Therapeutics’ first clinical study and are now focusing on progressing our clinical development program.”