Heptares announces positive early-stage dementia trial results

pharmafile | February 10, 2016 | News story | Research and Development Alzheimer's, Alzheimers, Heptares, dementia, schizophrenia 

Heptares has announced positive findings from its Phase 1b clinical study with its investigational drug HTL9936 as a treatment for patients with cognitive impairment due to dementia and schizophrenia.

In the Phase 1b study, 28 healthy elderly subjects were given different doses of HTL9936, to test the effect of drug on measures of brain activity while simultaneously monitoring side effects. Results showed that HTL9936, even at low doses, exhibited robust and statistically significant changes in brain electrical activity, and was generally safe and well tolerated.

HTL9936 is the first selective muscarinic M1 receptor agonist designed using Heptares StaR technology, which has entered clinical development as a new treatment for cognitive impairment in patients with dementia and schizophrenia. 

M1 agonists work by stimulating pro-cognitive M1 receptors on nerve cells in the brain, which substitutes for the diminishing levels of the neurotransmitter (acetylcholine) in patients suffering from these conditions.

The Sosei Group subsidiary says the early-stage trial results provide strong evidence in favour of the selective M1 agonist mechanism, and support progression of HTL9936 and similar molecules as treatments for cognitive disorders.

It was also demonstrated in the trial that M1 receptor stimulation resulted in none of the gastrointestinal side-effects (such as diarrhoea and vomiting) typically attributed to the stimulation of M2 and M3 receptors.

Heptares is also developing a second M1 agonist, HTL18318, currently in Phase 1 and for which results are expected later this year. Phase II studies in dementia and schizophrenia patients are expected to commence in late 2016.

Tim Tasker, chief medical officer of Heptares, says: “The results from this Phase 1b study reinforce our earlier findings from clinical and preclinical studies, providing compelling evidence to support the therapeutic potential of Heptares’ selective M1 agonists for improving cognitive function in patients with dementia and schizophrenia.  We are excited by these findings and look forward to progressing the M1 programme into patient studies later this year.”

Malcolm Weir, Heptares chief executive, added: “We are greatly encouraged by these findings from our lead M1 agonist programme.  We have generated a diverse portfolio of selective agonists that includes not only M1 but M4 agonists for treating psychosis in schizophrenia and Alzheimer’s disease patients, and dual M1/M4 agonists for both psychosis and cognitive impairment in these patients; we expect these to reach the clinic from early 2017 onwards. We believe this is a programme with the potential to deliver medicines of immense clinical and commercial significance.”

Joel Levy

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