Characterise the disruption
Multi-omics profiling identifies the specific ecological functions lost in an individual's dysbiotic state — establishing the precise targets for intervention before treatment begins.
Commitment to Patients
Treating the ecosystem, not only the symptom.
Gut dysbiosis is a known driver of gastrointestinal and immune-mediated disease. GutRecover's therapies are designed to re-establish protective microbial communities — offering durable alternatives to symptom-only approaches.
01 — Our Focus
How it works
A three-stage mechanism that addresses the root ecological failure — not the downstream symptom.
Re-establish protective communities
Defined consortia of characterised strains are administered to recolonise the disrupted ecosystem — restoring colonisation resistance, metabolic output, and mucosal immune regulation simultaneously.
Validate and sustain
Biomarker endpoints confirm ecological recovery. Durability of colonisation and functional restoration is monitored longitudinally — distinguishing genuine recovery from transient engraftment.
02 — Disease Areas
Recurrent C. difficile infection
GutRecover's lead indication, and the disease GR-101 is built for — the best-precedented setting for a defined live biotherapeutic, where post-infectious dysbiosis has a clear mechanism and donor-derived therapies already prove the principle.
Infection strips the gut's defences
Antibiotics that clear C. difficile also strip the gut of the secondary bile acids and short-chain fatty acids that keep it in check. Up to a third of patients recur after a first episode, and each recurrence raises the odds of the next — a self-perpetuating cycle standard antibiotics don't break.5,6
Probiotics fall short; FMT is undefined
Probiotics lack the defined composition and mechanism to restore colonisation resistance. Donor FMT works — it prevents recurrence by rebuilding the ecosystem6 — but relies on undefined, variable, unscalable donor material that carries pathogen-transfer risk. Defined consortia are the third path, and the first to reach approval.1,2
GR-101 rebuilds what infection removed
GR-101 closes the loop: a defined consortium of purified Clostridia selected to restore the exact functions lost after infection — secondary-bile-acid production that blocks C. difficile spore germination, and nutrient competition that denies it a foothold.4 The same modality as the first approved consortia, designed against the specific ecological deficit of post-infectious recovery.
GR-101 program →
03 — Clinical Trials
Clinical programs
Rigorous evaluation of efficacy and safety in target indications — with pre-specified biomarker endpoints, not symptom proxies.
RESTORe-101
A planned Phase 1, randomised, double-blind, placebo-controlled study of the safety, tolerability, and engraftment kinetics of GR-101 in adults with recurrent C. difficile infection — with longitudinal bile-acid and SCFA sampling as the mechanistic readout. Trial registration at IND.
Full program details →Ulcerative colitis program
IND preparation underway for the GR-201 program in ulcerative colitis. First-in-human study anticipated 2027. Academic collaborations active in validated colitis model systems.
Full program details →Gut–immune axis program
Early discovery stage. Multi-omics data generation and target identification ongoing. Clinical proof-of-concept design in development with academic partners.
Full program details →
04 — Clinical Trials
Expanded access policy
GutRecover Therapeutics is committed to making its investigational therapies available to patients with serious or life-threatening conditions who have no satisfactory alternatives and who are unable to participate in a clinical trial.
Expanded access requests are evaluated on a case-by-case basis against criteria including: the severity of the patient's condition, the absence of alternative therapies, the availability of evidence supporting a reasonable expectation of efficacy, and the ability to manage known and unknown risks.
Physicians wishing to request expanded access should contact the GutRecover medical affairs team. All requests are reviewed within five business days. GutRecover will not charge for investigational product provided under expanded access.