MaaT Touts 18-Month Data as Proof of Microbiome Therapy Viability

Microbiome biotech MaaT Pharma says it will market its pooled fecal treatment medicine for acute graft-versus-host disease (aGvHD) in two years based on data collected 18 months after the treatment’s long-running trial hold was removed.

A total of 140 patients with steroid-refractory or steroid-dependent gastrointestinal aGvHD who participated in the Pharma Early Access Program run by the French biotech were included in the 18-month data set. With a total survival rate of 54% at six months, 47% at a year, and 42% at 18 months, the findings clearly demonstrated a distinct survival edge among these individuals who were extensively pretreated.

The results showed that after 18 months, patients who reacted to MaaT013 had a substantially greater long-term survival rate (58% vs. 24%).

The pharmaceutical company also focused on 49 individuals whose conditions had not responded to steroids or Incyte’s Jakafi. The total response rate for the gastrointestinal system was 63% in this subset of patients, who are more similar to those in a current phase 3 study with MaaT013, compared to 52% in the whole cohort. This sample maintained an overall survival rate of 42% after 18 months.

MaaT CEO Herve Affagard shared his insights: “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 3 trial.”

Affagard highlighted the substantial impact on patients and emphasized that this advancement sets their treatment apart, especially in comparison to current options with limited advantages and associated serious complications. Expressing optimism regarding a promising phase 3 result and the possibility of a commercial launch in 2026, Affagard stated the firm’s aim to secure a significant portion of the market for third-line patients, signifying a pivotal moment in managing this condition.

In order to increase the variety and uniformity of MaaT013, MaaT explored the possibility of merging feces samples contributed by various donors. However, the method proved to be a source of contention in the U.S., where the FDA placed a hold on advancing the medicine into phase 3 for aGvHD for 20 months, which was not removed until April 2023.

The biotechnology company is conducting a phase 2 research in conjunction with immune checkpoint inhibitors to assess the treatment for metastatic melanoma. This is in addition to the phase 3 investigation of MaaT013 in patients with advanced-stage aGvHD.

The firm also holds MaaT033, another clinical-stage drug that it describes as ‘microbiome ecosystem therapy’. Currently, it’s in a phase 1 study for amyotrophic lateral sclerosis as well as a phase 2 trial aiming to improve survival rates among individuals with blood cancer who have been recipients of a bone marrow transplant.