Ensho Therapeutics has presented additional data supporting NSHO-101, also referred to as EA1080, as an oral one-time-a-day treatment for inflammatory bowel disease (IBD).
The presentation corroborated an earlier Phase I trial findings in healthy individuals, suggesting that the oral selective α4β7 integrin inhibitor could significantly block the binding of mucosal addressing cell adhesion molecule-1 (MAdCAM-1) to α4β7 integrin on peripheral blood cluster of clusters of differentiation 4 +(CD4+) T cells.
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The new data revealed that a once-daily formulation of the therapy maintained over or equal to 95% α4β7 receptor occupancy over a 24-hour period, with the active metabolite NSHO-101-M reaching steady-state levels within three to four days.
This correlated with maximal MAdCAM-1 binding inhibition. Furthermore, the inhibition persisted at over 90% for more than 72 hours following the final 800mg dose.
The Phase I clinical programme evaluated NSHO-101’s tolerability, pharmacokinetics, safety, pharmacodynamics, and food effects in 184 healthy volunteers, stated the company.
In this programme, the therapy demonstrated target engagement and was observed to be generally safe and well-tolerated.
Ensho Therapeutics founder and CEO Neena Bitritto-Garg said: “These data clearly indicate that NSHO-101 is effectively saturating the target with a once-daily dosing regimen and has an encouraging safety profile to date.
“We believe NSHO-101 could be transformational for patients suffering from IBD, as selective α4β7 antagonists have been proven to be safe and effective, but the need for oral agents remains.”
The company plans to initiate Phase II clinical development for the therapy as a potential ulcerative colitis treatment in the first half of this year.
Ensho Therapeutics develops oral therapies for inflammatory conditions, with a current focus on oral, selective small molecule inhibitors of lymphocyte homing integrin α4β7 for IBD.
It acquired its assets from Eisai subsidiary, EA Pharma, specialising in gastrointestinal conditions.
