MaaT Pharma a late-stage biotechnology company, leader in the development of dedicated Microbiome Ecosystem Therapies TM  1 to improve the survival of cancer patients, announces today that the Food and Drug Administration  has lifted the clinical hold and authorized the Investigational New Drug application (“IND”),submitted by the Company to initiate a single-arm, open-label, pivotal Phase 3 clinical trial in the United States evaluating the safety and efficacy of MaaT013 to treat acute graft-versus-host disease (aGvH) with gastrointestinal as third-line treatment.

“We are grateful for the FDA's continued engagement and are very pleased with the lifting of the clinical hold for the MaaT013 IND trial application. This is the first time that the Agency has authorised, in a Phase 3 trial in the United States, the clinical evaluation of a biological product derived from the microbiota and developed using “pooling 2” technology . The latter makes it possible to produce standardized therapies, containing a greater bacterial diversity, and which can be produced on a large scale, the objective of which is to improve the benefits for patients in complete safety. This major step is fundamental for making strategic decisions regarding the development of our portfolio outside the said Hervé Affagard, CEO and co-founder of MaaT Pharma. "The United States represents a strategic market for our therapies and we have already been able to capitalize on our past exchanges with the FDA by adapting our "pooling" technology for our entire portfolio according to the guidelines received during this regulatory process. ".

In parallel with the resolution of the clinical hold with the FDA, the clinical development of MaaT013 has progressed considerably, in particular within the framework of the ongoing pivotal international multicenter Phase 3 open-label Phase 3 (ARES) trial in Europe, launched in March 2022, and thanks to the continued accumulation of encouraging data from the compassionate access program. In this context, and before initiating clinical activities in the United States, MaaT Pharma plans to consult the FDA on the next steps of the regulatory procedure in order to allow American patients to have access to the MaaT013 product as soon as possible, while continuing the clinical development, currently at an advanced stage, of the latter in Europe.

“The positive response received today is a strong moment for MaaT Pharma in its mission to help patients through the development of safe and innovative medicines. It also confirms the reliability and safety of our donor selection protocols, which are now cleared for clinical evaluation in the United States and Europe. We are now in a position to also start discussions with the FDA for the clinical evaluation in the United States of MaaT033, our second drug candidate”, added Mr. Affagard. “This breakthrough also allows us to contribute to the development of the microbiota industry and to position MaaT Pharma as an industry leader”.

A propos de MaaT Pharma

MaaT Pharma is a clinical-stage biotechnology company that has developed a comprehensive approach to restore the microbiota/host symbiosis of cancer patients. Committed to the treatment of cancers and graft versus host disease (GvH), a serious complication occurring after a hematopoietic stem cell transplant, MaaT Pharma launched in March 2022, a Phase 3 clinical trial in patients with of acute GvH, after achieving the proof of concept of its approach in a Phase 2 clinical trial. Its powerful discovery and analysis platform, gutPrint® supports the development of its product portfolio and its extension to broader indications , by helping to identify new therapeutic targets, to evaluate drug candidates and identify biomarkers for the management of pathologies involving the microbiota. Therapies from a microbial ecosystem (Microbiome Ecosystem Therapies ) are all produced under highly standardized cGMP manufacturing and quality controls to ensure safe access to the diversity and richness of the microbiome, in oral or enema form . MaaT Pharma benefits from the commitment of world-renowned scientists and established relationships with regulatory authorities to advance the integration of microbiota-based therapies into clinical practice. MaaT Pharma is listed on Euronext Paris (Ticker: MAAT).

Forward-looking data

This press release contains forward-looking statements. All statements other than statements of historical fact included in this press release regarding future events are subject to (i) change without notice and (ii) factors beyond the Company's control. Such statements may include, but are not limited to, any statement preceded by, followed by, or including words such as "target", "believe", "expect", "aim", "intend", " can", "expect", "estimate", "plan", "project", "will", "can have", "likely", "probable", "must", "forecast" and other words and terms having a similar meaning or the resulting negative form.

1 Microbiome Ecosystem Therapy: Complete Ecosystem Microbiotherapy
2 “Pooling” technology: this technology, at the heart of MaaT Pharma's MET platform, refers to the procedure and process of mixing donations from several healthy donors.

Contacts
MaaT Pharma – Investor Relations
Hervé AFFAGARD, Co-founder/General Manager
Siân CROUZET, Administrative and Financial Director
+33 4 28 29 14 00
invest@maat-pharma.com

MaaT Pharma – Media Relations
Pauline RICHAUD
Senior PR & Corporate Communications Manager
+33 6 14 06 45 92
prichaud@maat-pharma.com

Trophic Communications
Corporate and medical communication
Gretchen SCHWEITZER or Jacob VERGHESE
+49 151 7441 6179
maat@trophic.eu
 

Source:businesswire.com

Report Abuse