AC Immune SA has reported encouraging interim results from its phase 2 VacSYn clinical trial of ACI-7104.056, an anti-alpha-synuclein (a-syn) active immunotherapy for early Parkinson’s disease (PD).

The trial, involving over 30 patients, showed that ACI-7104.056 induced high levels of anti-a-synuclein antibodies, averaging 16-fold higher than those in the placebo group after three immunisations.

Dr Andrea Pfeifer, CEO of AC Immune, remarked, “We are encouraged by these initial phase 2 safety and immunogenicity data on our ACI-7104.056 active immunotherapy being studied in early Parkinson’s disease.

"The level of immunogenicity after only three months of treatment as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for the treatment of Parkinson’s disease.”

The trial, which is randomised, placebo-controlled and biomarker-based, is being conducted across various countries, including the UK and Spain. It aims to recruit up to 30 patients with mild-to-moderate PD.

The interim results have shown that 100% of patients receiving ACI-7104.056 responded positively against the target antigen, with no significant safety issues reported other than transient injection site reactions and headaches.

Dr Pfeifer further stated, “As a leader in active immunotherapies for neurodegenerative diseases with two FDA Fast Track designated candidates, an important recognition of their promise, we are delighted with these initial VacSYn data.”

Microbiotica, a clinical-stage biopharma company, has announced the dosing of the first patient in its phase 1b first-in-human trial, COMPOSER-1, for MB310 in ulcerative colitis (UC) patients.

This international trial aims to recruit up to 30 adult patients across the UK, Austria, Bulgaria, Poland and Spain. Initial data readouts are expected by the end of 2025.
Ulcerative colitis, an inflammatory bowel disease, affects over 1.4 million people globally.

MB310, developed as an oral capsule dosed once daily, contains a consortium of eight live gut commensal bacterial strains designed to deliver long-term remission without immunosuppression or unwanted side effects.

The COMPOSER-1 study will assess the safety, tolerability and initial efficacy signals of MB310 in a randomised, placebo-controlled, double-blind clinical trial.

The trial will measure the engraftment success of the bacteria within MB310 into patients’ intestinal microbial community.

Patients with active, mild-to-moderate UC will take two capsules of the study medication (active or placebo) daily for 12 weeks, alongside their standard medication, followed by a 12-week follow-up period.

Professor Walter Reinisch, a principal investigator in the study, said, “Microbiota dysregulation is known to be a key driver to the pathogenesis in ulcerative colitis. The COMPOSER-1 study offers us a unique opportunity to treat UC by rebalancing the microbiota with this new treatment modality and potentially inducing long-term disease remission in our patients.”