In March, the publication of a series of papers documenting the presence of SARS-CoV-2 or its RNA in the stools of infected individuals led regulators to reconsider their positions on treatments that make use of feces. The US Food and Drug Administration imposed additional donor screening and testing requirements, and the French National Agency for Medicines and Health Products Safety (ANSM) put restrictions on the collection and use of stools.
The French restrictions affected MaaT, a biotech that is developing microbiome biotherapeutics that contain bacterial strains derived from human stools. MaaT began a stool collection and production campaign weeks before ANSM imposed the restrictions.
With ANSM stopping the collection of fecal microbiota products for use in medicine manufacturing, MaaT has been unable to gather stools in its home country. That changed earlier this month.
Today, ANSM is permitting the collection of stools for medicine manufacturing, provided additional precautions are taken. MaaT will need to place raw and manufactured material under quarantine until additional protection measures are established. The protection measures may necessitate the retrospective screening of materials before they are released.
While France is yet to get back to the pre-COVID-19 situation, MaaT sees the new normal as giving it enough freedom to justify restarting collection and manufacturing.
MaaT will follow the new guidelines and has implemented new protocols and screening measures in light of ANSM’s guidance. The measures are intended to protect patients, stool donors, partners and staff.
The collected stools will support clinical evaluations of MaaT’s oral and enema formulations of the same biotherapeutics, respectively called MaaT033 and MaaT013. MaaT initiated a phase 2 trial of enema formulation MaaT013 in patients with corticosteroid-resistant acute graft-versus-host disease in 2018. Oral formulation MaaT033 is set to enter the clinic in leukemia patients later this year.
If MaaT hits that target, it may escape the COVID-19 pandemic with the program on track. MaaT said it planned to start the clinical trial in the second half of the year when it raised €18 million ($21 million) to fund the work in January.
MaaT is moving into the clinic in leukemia on the strength of evidence the microbiome influences the outcomes achieved by checkpoint inhibitors, such as Merck’s Keytruda and Bristol Myers Squibb’s Opdivo.