MaaT Pharma Announces Promising Final Data Readout for Phase 1b Evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS)
LYON, France, May 12, 2025--(BUSINESS WIRE)--Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced additional findings following full data readout for the exploratory single-arm, open-label Phase 1b clinical trial named IASO (NCT05889572) evaluating MaaT033 in Amyotrophic Lateral Sclerosis (ALS).
In November 2024, the Company announced that the trial had met its primary endpoint assessing the safety and tolerability of MaaT033 with multiple doses, following the independent Data Safety and Monitoring Board (DSMB) conclusion. As a reminder, the exploratory Phase 1b trial enrolled a total of 15 participants across two centers in France Hôpital de la Pitié-Salpêtrière – AP-HP and the University Hospital of Lille. An external Scientific Advisory Committee took place at the end of March 2025 to review the full data. Below are the key takeaways from the Committee's review:
MaaT033 demonstrated a favorable safety and tolerability profile, supported by biomarker and microbiome analyses.
A rapid and sustained engraftment of bacterial species from MaaT033 was observed, mostly occurring within the first month and maintained during the 1-month follow-up period.
A slower rate of disease progression (based on ALSFRS-R slopes) was noted to be interpreted with caution given the short follow up, limited sample size and single-arm Phase 1b design. The ALSFRS-R is a standard functional scale in ALS trials to track the progression of the disease. The slope reflects how many points are "lost" (=disease progression) per month. In the final data readout for the IASO trial, the following was observed for the ALSFRS-R Total score slope:
From first symptoms to baseline, the median slope was –0.7 points/month (range: –1.2 to –0.3)
From baseline to Day 84 (D84), the median slope slowed to –0.3 points/month (range: –2.4 to +1.0)
No variation at D84 in the levels of neurofilaments, a marker associated with neuronal injury in ALS.
In addition, the Scientific Advisory Committee provided insights regarding the best population to target in a Phase 2 trial.
"These encouraging findings from the IASO Phase 1b trial confirm the favorable safety and tolerability profile of MaaT033 in ALS patients. They also highlight the therapeutic potential of microbiome modulation beyond oncology and open new avenues for development in neurodegenerative diseases, as evidence continues to grow around the gut-brain connection," said Gianfranco Pittari, MD, PhD, Chief Medical Officer of MaaT Pharma.
The study was conducted in close collaboration with the French patient association Tous en Selles contre la SLA (TECS), highlighting the essential role of patients and their advocates in advancing science, and with the support of experts from the French academic networks FILSLAN and ACT4ALS-MND.
"Recognizing the significant unmet medical need in ALS and with the will to support those affected, we applied our discovery platform to this new disease area, demonstrating its potential beyond our primary focus in oncology with encouraging Phase 1 data. In light of the Company's strict financial discipline, and considering the recent successes achieved in oncology, we are actively seeking partners with a focus on ALS and the financial capacity to support new options to fight this disease," stated Hervé Affagard, CEO and co-founder of MaaT Pharma.
–--
About MaaT033MaaT033, a standardized, donor-derived, high-richness, high-diversity oral Microbiome Ecosystem TherapyTM containing anti-inflammatory ButycoreTM species, is currently being developed as an adjunctive therapy to improve overall survival in patients receiving HSCT and other cellular therapies. MaaT033 is developed with the "pooling" technology, which allows pooling donations from multiple donors to create a standardized product with high microbial richness and diversity. It aims to ensure optimal microbiota function and to address a larger patient population in a chronic setting. MaaT033 has been granted Orphan Drug Designation by the European Medicines Agency (EMA).
About Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease in the US and Charcot's disease in Europe, is a progressive neurodegenerative disorder affecting motor neurons in the brain and spinal cord. This leads to muscle weakness, loss of voluntary movement, and eventually, paralysis and on an average lead to death in 3 to 5 years. ALS could affect up to 60,000 patients in US and EU by 2040 and has currently no curative treatment and few symptomatic treatments.
About MaaT PharmaMaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France.As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.
Forward-looking StatementsAll statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as "target," "believe," "expect," "aim", "intend," "may," "anticipate," "estimate," "plan," "project," "will," "can have," "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250511855391/en/
Contacts
MaaT Pharma – Investor RelationsGuilhaume DEBROAS, Ph.D.Head of Investor Relations+33 6 16 48 92 50invest@maat-pharma.com
MaaT Pharma – Media RelationsPauline RICHAUDSenior PR & Corporate Communications Manager+33 6 14 06 45 92media@maat-pharma.com
Rx Communications Group – U.S. Investor Relations Michael MillerManaging Director+1-917-633-6086mmiller@rxir.com
Catalytic Agency – U.S. Media Relations Heather SheaMedia relations for MaaT Pharma +1 617-286-2013 heather.shea@catalyticagency.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
28 minutes ago
- Yahoo
France Moves to Curb ‘Ultra-fast' Fashion With Bill Targeting Shein and Temu
PARIS — As major brands scale back their sustainability initiatives, France is pressing ahead with legislation aimed at reining in 'ultra-fast fashion' platforms such as Shein and Temu, known for their extremely low-cost clothing. The bill, introduced by Anne-Cécile Violland, a member of parliament from the Horizons party, passed the Senate one year after clearing the lower house of the French Assembly. More from WWD Inditex Sales Slow as Economic Headwinds Hit the High Street Rebag Expands Access to Pre-loved Luxury Goods With New Amazon Collaboration Designer Vincent Van Duysen Opens Antwerp Home for Zara Home+ 4th Collection The unusually long gap between votes led to some watering down of the original provisions, exempting traditional fast-fashion players such as H&M, Primark, and Inditex-owned Zara. 'It's a relief that it moved forward, but there has been a shift in the goal of the legislation that it is now specifically targeting what is called 'ultra-fast fashion,'' said Pierre Condamine, spokesperson for the Anti Fast Fashion Coalition, an umbrella group of 11 environmental organizations in France. Earlier drafts had adopted a broader definition of fast fashion that included Europe-based brands. 'There is sort of a shift in what was supposed to be an environmental legislation, with the objective to shift the whole sector towards sustainable practices, while now it's sort of becoming a protectionist text,' he told WWD. The revised bill targets ultra-fast fashion directly, proposing a tax on small parcels shipped from outside the EU ranging from 2 to 4 euros per package. The fee is intended to slow the influx of packages from Chinese platforms to France, in a move reminiscent of the U.S. ending its de minimis exemption. Shein and Temu together shipped 800 million packages to France in 2024 — more than half of all parcels sent to the country. The French government will first notify the European Commission, as several measures, including a total advertising ban on ultra-fast-fashion platforms, require approval at the EU level. This process could take up to three months before the bill goes to the Assembly and Senate joint committee for resolution, likely in the fall in late September or October. Several key provisions may face scrutiny in Brussels, including the parcel fee, which could conflict with the European Commission's plan for a bloc-wide fee by 2028, and the proposed national advertising ban. Although Shein is registered in Singapore, its European headquarters in Ireland could present a legal loophole. As it stands, the bill mandates eco-contributions from fashion companies based on a 'bonus-malus' system — rewarding sustainable practices and penalizing environmental harm. Penalties could rise to 10 euros per item by 2030, though the methodology for valuing items has yet to be defined. The bill would also eliminate tax advantages for 'donating' unsold stock by ultra-fast-fashion brands, which are not permitted to destroy unsold items under an anti-waste law passed in 2020. A critical element of the bill is its specific definition of 'ultra-fast' or 'ultra-express' fashion. This distinction leaves out more traditional fast-fashion companies that have a retail presence like H&M, Primark and Zara. By differentiating between ultra-fast platforms and fast-fashion brands with physical retail locations, the legislation potentially creates a loophole for companies headquartered in Europe — Sweden, Ireland and Spain respectively — even though their production relies heavily on low-wage countries like China, India and Bangladesh via subcontractors and diffuse supply chains. The original bill passed by the Assembly featured the broader definition, but companies lobbied intensively over the past year for the narrower language, arguing that they contribute to local employment. Senator Sylvie Valente Le Hir of Les Républicains, who ushered the bill through the Senate, highlighted its targeted approach: 'We have drawn a clear line between those we want to regulate — ultra-express fashion — and those we want to preserve, accessible but rooted fashion, which employs in France, which structures our territories, which creates links and supports a local economic fabric,' she said. The industry group La Fédération Française du Prêt à Porter Féminin praised the bill as a 'step forward' in tackling ultra-fast fashion. 'It formalizes the long-standing collective commitment of many stakeholders to defend a fashion industry that respects workers, consumers, citizens, French businesses, and the planet,' the organization said in a statement. However, Condamine noted that while large global fast-fashion retailers remain profitable – Zara's parent company Inditex reported sales were up 4.2 percent in constant-currency in the first quarter on Wednesday — French high street brands like Camaieu and NafNaf have entered administration, and independent stores continue to shutter. 'The economic crisis in the clothing industry in France, it started way before Shein,' Condamine said. 'It started when fast fashion — Zara, H&M, Primark — arrived. Now they are saying if they're targeted, it will be a catastrophe [for jobs]. But they're doing great economically, and they're part of the problem.' Some lawmakers described the bill as a 'strong first signal' and indicated that fast fashion as a whole — including the European players with physical presence — could face future regulation due to unsustainable business practices. On the other hand, critics — chiefly Shein — have said the legislation punishes cost-conscious consumers and lower-income households. The company, which markets itself under the slogan 'Fashion is a right, not a privilege,' has staged events in French cities like Béziers. On Sunday, its director of government relations, Fabrice Layer, held a presentation in front of the southeastern town's city hall to rally public support for the company. 'We ultimately find ourselves with a law that is not only anti-Shein, but anti-Shein customer,' Quentin Ruffat, Shein's spokesperson in France, told AFP. 'This law, if passed, will directly penalize our customers' wallets and drastically reduce their purchasing power.' The company has also accused France's fashion establishment of protecting legacy brands and says it will continue lobbying to amend the bill further. Shein representatives did not respond to requests for comment. New research from l'Institut Français de la Mode (IFM) shows that in the first quarter of 2025, Amazon, Shein and Temu together accounted for 24 percent of online apparel sales by value, representing 7 percent of total apparel consumption across all channels. Online sales made up 29.4 percent of apparel purchases by value, including the online stores of traditional retailers. Best of WWD Walmart Calls California Waste Dumping Lawsuit 'Unjustified' Year in Review: Sustainability's Biggest Controversies of 2021 Year in Review: Sustainability's New Strides
Bloomberg
an hour ago
- Bloomberg
Mitsubishi Buys Stake in Private Equity Real Estate Firm Patron
Mitsubishi Estate Co. has bought a majority stake in European private equity property fund manager Patron Capital, the latest sign of Japanese investment washing into the UK. The Tokyo-based group's investment management business, Mitsubishi Estate Global Partners, is acquiring the stake from Patron's management led by founder Keith Breslauer, according to a statement Thursday. The deal will see Mitsubishi commit about €600 million ($686 million) of equity to Patron's funds to help it build out new strategies including its nascent credit business, it said.
Motor 1
an hour ago
- Motor 1
Maserati May Already Be Planning the MC20's Successor
It's wild to think that the Maserati MC20 is already five years old. The car made its official debut in September 2020, and the automaker might already be readying the supercar's successor. Maserati has recently filed a new trademark that sounds like a natural progression of the company's current naming scheme for its supercars. The Italian-based automaker filed a trademark application for " MC25 " to be used on cars and scale model vehicles with the United States Patent and Trademark Office. That seems like the perfect moniker for a new car that would debut this year. However, there's no public indication Maserati is preparing an MC20 successor as the company faces a chaotic industry. Maserati's Difficult Future Sales for the brand were down 57 percent last year , declining from 26,600 cars in 2023 to just 11,300 units in 2024. The brand has also culled its lineup in recent years, discontinuing best-sellers like the Levante and Ghibli, with replacements still a few years away. The company also had to fend off rumors last year that alleged Stellantis was preparing to sell the struggling brand. Stellantis then reiterated its commitment to Maserati in April, confirming that the brand was not for sale . It might not have the resources for a completely new car, but Maserati could easily make some significant upgrades to the MC20 for a new iteration. The automaker previewed what could be possible with the powertrain back in 2023 with the MCXtrema , a track-only super making 730 horsepower from the Nettuno twin-turbocharged 3.0-liter V-6 engine. A new iteration of the car featuring revamped styling, a new name, and other performance upgrades might be in the works. However, we'll have to wait for something official from the company. It has a lot to sort out as it navigates the ever-changing auto industry. Read More Maserati News: You Can Get a Stupid Cheap Maserati From Hertz Maserati Sales Aren't Doing Great Get the best news, reviews, columns, and more delivered straight to your inbox, daily. back Sign up For more information, read our Privacy Policy and Terms of Use . Source: US Patent and Trademark Office via CarBuzz Share this Story Facebook X LinkedIn Flipboard Reddit WhatsApp E-Mail Got a tip for us? Email: tips@ Join the conversation ( )
