· Phase IItrial will assess efficacy of EXL01 as treatment to prevent post-operative recurrencein patients with Crohn’s disease
· Trial builds on MAINTAIN Part Astudy that supports good safety profile of EXL01 as maintenance treatment followingsteroid-induced remission in patients withmild-to-moderate Crohn’s disease
· Part A of MAINTAIN study closed due to slowrecruitment
· MAINTAIN POP trial to start early 2025 with toplineresults expected in Q1, 2027
Paris, France, June 25, 2024 – ExeliomBiosciences, a clinical-stage biotechnology company developing new therapies inimmuno-inflammation and immuno-oncology,today announces its collaboration with REMIND, a nationwide consortium of 14 Frenchgastroenterology departments, in the MAINTAIN POP study, a phase IIpost-operative interventional trial in Crohn’s disease. It will be acontinuation of Exeliom’s efforts in Crohn’s disease after the company decidedto close the MAINTAIN clinical study at the end of Part A due to a slow recruitment.
MAINTAIN POP is a phase IIrandomized placebo-controlled trial that will involve 13 sites in the REMINDgroup. It aims to enroll 80 patients with Crohn's disease who have successfullybeen brought to remission by surgery, to evaluate EXL01 as a stand-alonemaintenance treatment or in combination with anti-TNFs. The study will assessboth the safety and efficacy of EXL01 against endoscopic endpoints (e.g.endoscopic recurrence at six months post-surgery). This is a post-operativeinterventional study - coordinated by the REMIND group.
MAINTAIN POP is a continuation of thework undertaken in MAINTAIN (NCT05542355), a first-in-human phase I trialevaluating EXL01 for the maintenance of steroid-induced remission in patientswith mild to moderate Crohn’s disease. The preliminary results support agood safety profile for EXL01 in combination with corticosteroids and as amonotherapy in patients with Crohn’s disease, as recently confirmed by theIDMC.
Despiteencouraging safety data from Part A of the study, Exeliom reached theconclusion that continuing the study was no longer operationally feasible.While no participant discontinued EXL01 treatment due to adverse events, recruitmentinto Part A of the study proved challenging, with a net recruitment rateapproximately one-tenth of that projected at the study's outset. Thefinal results are expected to be delivered in the first half of 2025, including preliminarytranslation data regarding target engagement.
“The decision to halt recruitment in MAINTAIN at the end of Part A does not diminish our commitmentto advancing the clinical development of EXL01 in Inflammatory Bowel Disease(IBD), particularly Crohn’s disease,” said Benjamin Hadida, CEO of Exeliom. “Weare happy to announce the launch of this new study, MAINTAIN POP, incollaboration with REMIND, a renowned translational research organizationspecializing in IBD, to further these efforts.”
“There is a clear unmet need for an effective and well-tolerated medicineto help patients with Crohn's disease maintain their periods of remission. Exeliom can build on preliminaryresults which support the expectation of the good safety profile of EXL01 as amonotherapy for Crohn’s patients,” said Pr. Harry Sokol, professor ofgastroenterology at Saint-Antoine hospital in Paris and co-founder of Exeliom.
“Surgery is a frequent event inthe life of Crohn’s disease patients, unfortunately followed by a high risk ofrecurrence. We will assess the impact of EXL01 on preventing this recurrence,”said Pr. Matthieu Allez, professor at Saint-Louis hospital in Paris, andco-founder and president of the REMIND group.
The clinical trial authorization for MAINTAIN POP willbe submitted in September 2024, with the aim of starting enrollment in early2025 and publishing topline results in Q1, 2027.
About Crohn’s disease
Crohn’sdisease is a growing public health concern, with a prevalence of more than 1.6 million people in Europe. Upto 70–80% of patients with Crohn’s disease require surgery. Surgery isassociated with a state of remission but is not curative, as most patients willexperience disease recurrence during the following five years, which has asignificant impact on quality of life (QoL) and an important socio-economicburden. For several reasons, including cost, safety issuesand patient’s expectations, approximately half the patients do not receive atreatment immediately after surgery. However, many of these patients experiencea significant early endoscopic recurrence, despite no risk factors.
AboutEXL01
EXL01 is a live biotherapeutic product (LBP) containingan unmodified single-strain of F. prausnitzii, a key player in the humangut microbiome, which is being developed as a new immune modulating medicine.EXL01 acts on key innate immune system targets to trigger non-suppressiveinflammation resolving mechanisms. Currently, thereis no cure for IBD and only two other LBPs have been evaluated in clinic withencouraging results, both for UC. With promising published results of Fecal Microbiota Transplantation (FMT)in Crohn’s disease, there is a great potential for LBP treatments for managingCrohn’s disease.
About REMIND
The REMINDgroup was established in 2006 and gives access to a network of gastroenterologistsspecialized in IBD and working in numerous gastroenterology referral centers inFrance and Belgium, as well as basic and translational researchers. Most areaffiliated to both gastroenterology departments and academic laboratories(Inserm).
The globalstrategy is to foster interactions between researchers in the IBD field and toprovide new insights into the understanding of the physiopathology of IBD; toimprove the management and treatment of these complex chronic inflammatorydisorders by linking high quality and exhaustive clinical data with dedicatedanalysis of the patients’ samples, using various approaches integrating genetics,immunity and microbiota.
Having already established a first cohort of more than 700patients with perfectly curated clinical information, the REMIND group has thestatistical and bioinformatics knowledge and know-how to integrate larger datasets.
www.grouperemind.org
About Exeliom Biosciences
Exeliom Biosciences is developing new therapies in immuno-oncology andimmuno-inflammation. Its candidates improve patients' ability to respond totreatments in settings where dysregulated immunity can impede efficacy, such asinflammatory bowel diseases, solid tumor cancers and chronic infectiousdiseases. Exeliom Biosciences’ lead candidate, EXL01, is a single-strain livebiotherapeutic product that exploits the unique ability of a commensalbacterium (Faecalibacterium prausnitzii) to simultaneously activateseveral pivotal regulators of inflammation. As such, it offers a novel strategyto modulate inflammation. EXL01's unique immunomodulatory profile may be exploitedto attenuate resistance to existing treatments when administered in combinationwith them. EXL01 is being evaluated in several clinical trials, including aphase I trial in Crohn's, three phase II trials in immuno-oncology incombination with immune checkpoint inhibitors and a phase I/II trial in theprevention of recurrent C. difficile infection. In parallel, ExeliomBiosciences has developed a multimodal pipeline.
Exeliom isbased on strong scientific foundations and has aworld-renowned team, led by Pr. Harry Sokol, gastroenterologist andhepatologist at Saint-Antoine Hospital, AP-HP and Sorbonne University, Dr.Philippe Langella, research director at INRAE, and Pr. Patrick Gervais, processengineering specialist at AgroSup.
Founded in2016 and headquartered in Paris, Exeliom has raised a total of €27 million ($29M)since its inception. The company has been awarded the ‘Plan de relance 2030’,‘Deeptech’ and ‘I-Lab’ awards by Bpifrance, and the ‘EIC Accelerator’ by theEuropean Innovation Council Fund. It has also received financial support fromthe Crohn's & Colitis Foundation of America.
www.exeliombio.com
