The trial will assess the proof-of-concept efficacy of IMCY-0098 in adults newly diagnosed with T1D. Credit: Manu5 / commons.wikimedia.org.

Imcyse has concluded enrolment of patients in the Phase II IMPACT (IMCY-0098 Proof of ACtion in Type 1 ciabetes) clinical trial of IMCY-0098.

IMCY-0098 is the company’s lead product candidate and a proinsulin-derived Imotope, which has been developed stop the progression and prevent early-onset Type 1 diabetes (T1D).

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The multi-centre, double-blind, randomised, placebo-controlled, dose comparison trial will assess the proof-of-concept efficacy of IMCY-0098 in adult patients who have been newly diagnosed with T1D.

Carried out in partnership with INNODIA, the study exceeded its recruitment target. A total of 110 patients were enrolled and randomised across 28 trial sites in the US, Europe, and Australia.

The European T1D network INNODIA consists of 40 members including industrial partners, academic institutions, and patient organisations.

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In the trial, the subjects are randomised into a 1:1:1 ratio to receive multiple doses, along with a booster of 450μg IMCY-0098, 1350μg IMCY-0098, or a placebo.

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The change from baseline in C-peptide level is the trial’s primary endpoint and secondary endpoints include haemoglobin A1C levels, insulin use, and continuous monitoring of glucose.

Topline results from the Phase II trial are expected in the first quarter of next year, based on the follow up period of 48 weeks.

Imcyse CEO Denis Bedoret said: “Reaching the enrollment target is a key milestone in our effort to advance IMCY-0098 as a disease-modifying treatment and clinical proof of concept for the Imotope platform.

“Imcyse has made significant strides in the past year evolving into a clinical-stage company, with two candidates now in clinical development and other programmes advancing towards the clinic.”

A previously reported interim biomarker analysis data from the Phase II IMPACT trial showed that IMCY-0098 treatment induces an insulin-specific cytolytic CD4+ immune signature.