French clinical-stage biotechnology and microbiome therapy company MaaT Pharma has seen success with its Phase III trial of MaaT013 meeting its primary endpoints, leading to a jump in the company’s stock price.
Results from the company’s ARES trial (NCT04769895), a single-arm, open-label, multicentre Phase III trial, evaluated MaaT013, described as a full-ecosystem, off-the-shelf, standardised, pooled-donor enema microbiome ecosystem therapy designed to restore balance and clinical benefit for patients living with severe, treatment-induced dysbiosis in acute diseases.
Primary endpoints included a significant gastrointestinal overall response rate (GI-ORR) at 28 days of 62%, exceeding the expected 38% response rate the company had initially set for itself. The trial sought to examine the therapy in Graft-versus-Host Disease patients with gastrointestinal involvement (GI-aGvHD) in third-line treatment who were adverse steroids or intolerant to ruxolitinib.
Now, the company’s share value has climbed 14.71% since the announcement, growing from €8.02 before the release of the results, to €9.20 per share at the time of publication.
Gianfranco Pittari, chief medical officer for MaaT Pharma said: “These positive topline results strongly position MaaT013 as a first-in-class therapeutic for GI-aGvHD, potentially bringing a new option for patients in need of effective treatments when both steroids and ruxolitinib have failed.
“ARES represents the first-ever positive pivotal clinical study for an immunosuppressant-sparing, microbiome-based approach, confirming MaaT Pharma’s leadership in the field, validating the Company’s therapeutic platform, supporting its programs, and broadens potential applications in oncology, inflammation, and other therapeutic areas.”
The trial saw 66 adult patients with GI-aGvHD treated with MaaT013 across 50 sites in Austria, Belgium, France, Germany, Italy and Spain. The results also saw patients benefit from a higher overall prolonged survival rate with the treatment. The company said that GI-ORR at day 28 occurred in 41 out of 66 patients (62%) and consisted of complete response (CR) and very good partial response (PR) patients. The company said it intends to unveil further results as part of an upcoming conference call.
Mohamad Mohty, head of Haematology and cellular therapy at Saint-Antoine Hospital and Sorbonne University added: “GI-aGvHD is a devastating condition, particularly for patients who do not respond to ruxolitinib. These individuals face an urgent unmet medical need, with alarmingly low survival rates and a critical lack of effective treatment options.
“The results for MaaT013 in this Phase III trial represent a groundbreaking advancement in third-line treatment for GI-aGvHD. By directly targeting the gut-immune interface, this innovative therapy has the potential to redefine disease management, bringing new hope to patients and clinicians, alike.”
The trial follows the company's success at the end of last year with its Phase II study of its immune system modulator, MaaT-033. Elsewhere in the field of microbiome therapy, Microbiotica has dosed the first subject in the Phase Ib MELODY-1 clinical trial of MB097, a precision microbiome co-therapy targeting advanced melanoma.
