Long-term data indicates “significant” potential of aGvHD microbiome treatment

Positive data from MaaT Pharma’s Microbiome Ecosystem Therapy^TM (MET) MaaT013 as a treatment for acute graft-versus-host disease (aGvHD), is set to be presented at the 2024 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting.

Based on the long-term survival data, at 18 months MaaT013 enabled 42 percent overall survival in all patients and 58 percent in responder patients.

“MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies. This effect is coupled with reduced toxicity compared to standard immunosuppressive drugs. Notably, these results are achieved with just three doses in less than two weeks of treatment initiation,” Dr Florent Malard, Professor of Haematology at Saint-Antoine Hospital and Sorbonne University in Paris commented.

Advancing microbiome innovation

As third line treatment, MaaT013 facilitated a 63 percent gastrointestinal overall response rate (GI-ORR) at D28 and 53 percent at D56. MaaT Pharma stated that this represents “the highest overall survival” in patients with aGvHD when compared to reported evidence in the literature (Abedin et al., 2021).

This data summary is based on an abstract from the Annual Meeting.

“The confirmation of an improvement in 18-month survival, compared to the data already presented, by the company, at 12 months, reinforces our confidence in the ongoing development, notably the results of the current Phase III trial,” stated Hervé Affagard, CEO and co-founder of MaaT Pharma. 

“Beyond the significant impact for patients, this advancement distinguishes our treatment in a context where current options offer only limited benefits and lead to severe complications. Anticipating a positive Phase III outcome and a potential commercial launch in 2026, we aim to capture a substantial share of the market for third-line patients, thereby marking a turning point in the management of this condition,” Affagard added.

MaaT Pharma’s ongoing clinical trials

The company stated that the ongoing pivotal Phase III trial of MaaT Pharma’s microbiome treatment MaaT013 in patients with corticosteroid and ruxolitinib-refractory GI-aGvHD is planned to provide confirmation of the results from the Early Access Program (EAP).

Furthermore, MaaT Pharma shared that its ongoing Phase IIb trial for MaaT033 developed as an adjunctive therapy to enhance overall survival in allogeneic hematopoietic stem cell transplantation “is the largest randomised controlled study to date of a microbiome-based therapy in oncology”.