EXL01 is a first-in-class immunomodulator and single-strain Live Biotherapeutic Product derived from Faecalibacterium prausnitzii, a key player in the gut microbiome.

Leveraging the distinct peptidoglycan structure of F. prausnitzii, EXL01 hyperactivates the NOD2 pathway to drive metabolic reprogramming in monocytes and macrophages, resulting in superior immune-modulatory effects.

Designed for oral, daily administration, EXL01 is a gastro-resistant drug engineered to release precisely in the jejunum and ileum, ensuring targeted immune activation without requiring gut colonization.

A reduction in Faecalibacterium prausnitzii levels has been linked to several inflammatory bowel diseases, including Crohn’s Disease (CD).
EXL01, formulated with a strain of F. prausnitzii, has demonstrated potent anti-inflammatory properties in both human and mouse models, primarily through the induction of IL-10 signaling.

Building on this foundation, EXL01 has shown its ability to induce a direct, dose-dependent production of IL-10 in CD14+ monocytes from both systemic circulation and intestinal tissues of IBD patients, without triggering a pro-inflammatory response. Remarkably, this IL-10 production is driven by EXL01’s capacity to reprogram cellular energy metabolism, with its anti-inflammatory effects dependent on mitochondrial respiration.
By both inducing an anti-inflammatory response and rewiring energy metabolism in human monocytes, EXL01 addresses critical mechanisms underlying intestinal inflammation.

Following the successful completion of a Phase 1 trial in Crohn’s disease patients, EXL01 is now being evaluated in a Phase 2 study as both a monotherapy and an adjuvant to anti-TNF treatments, offering new hope for patients with IBD :
A Phase 2 multicentre, randomised, parallel-arm, placebo-controlled, double-blind study to evaluate the safety and target engagement of EXL01 in the prevention of postoperative recurrence of Crohn’s Disease
– Sponsored by REMIND - Recruiting