Seres Therapeutics receives FDA Breakthrough Therapy Designation for SER-155 after showing it leads to 77% relative risk reduction in bacterial bloodstream infections compared to placebo back in September 2024. What does this mean? - More intensive FDA guidance to push towards its commercialization - Improved potential for an expedited review process if we continue seeing the Phase 1b success in 2025 This announcement highlights the positive impact of microbiome modulation on improving patient outcomes in medically vulnerable communities using LBPs, and is going to pave the way for other companies to follow in their footsteps. Super exciting times ahead for the microbiome community.
Microbiome Movement
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Translating Innovative Microbiome Research into Safe & Effective Products
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Microbiome Movement reposted this
Save the date! 👏 Benjamin Hadida, our CEO, will attend the 9th annual Microbiome Movement Summit next year, January 28 to 30, in Barcelona. 🔬 He will share some brand new updates regarding our ongoing clinical studies and our mechanistic work. 🚀 Don’t miss Europe’s only industry-centric Microbiome Movement Summit, a 3-day deep dive into microbiome R&D & microbial therapeutic development, looking to translate this research into improved healthcare outcomes Find the program here: https://ter.li/54oiq3
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Partnership Director | Bioprocessing 🦠 Connecting innovative solution providers with key industry leaders in microbiome product development.
Concerto Biosciences 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐅𝐢𝐫𝐬𝐭 𝐏𝐚𝐫𝐭𝐢𝐜𝐢𝐩𝐚𝐧𝐭 𝐃𝐨𝐬𝐞𝐝 𝐰𝐢𝐭𝐡 𝐋𝐢𝐯𝐞 𝐁𝐢𝐨𝐭𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜 𝐄𝐍𝐒-𝟎𝟎𝟐 𝐢𝐧 𝐏𝐡𝐚𝐬𝐞 𝟏 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐀𝐭𝐨𝐩𝐢𝐜 𝐃𝐞𝐫𝐦𝐚𝐭𝐢𝐭𝐢𝐬 𝐊𝐞𝐲 𝐈𝐧𝐟𝐨: - ENS-002 is a three-strain #LBP targeting 𝘚. 𝘢𝘶𝘳𝘦𝘶𝘴 - 𝘚. 𝘢𝘶𝘳𝘦𝘶𝘴 is a key driver of skin #inflammation - Hopefully, by addressing a #microbiome deficiency underlying atopic dermatitis, ENS-002 can offer a novel route to longer-lasting relief and fewer side effects than traditional treatments like steroids and immunosuppressants. 𝐓𝐫𝐢𝐚𝐥 𝐃𝐞𝐬𝐢𝐠𝐧: - Enrolling approx. 9 participants across 3 cohorts of increasing dose concentration and dose frequency. - Primary endpoints: safety & tolerability - Secondary endpoints: ability of ENS-002 to control 𝘚. 𝘢𝘶𝘳𝘦𝘶𝘴 abundance and address atopic dermatitis 𝐖𝐡𝐚𝐭'𝐬 𝐍𝐞𝐱𝐭? Concerto anticipates being able to report safety and preliminary proof of mechanism data in 2025. Link to article: https://lnkd.in/egzVx_fg
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First-in-human trial for gut microbiome transplants for Parkinson's in Japan...
Partnership Director | Bioprocessing 🦠 Connecting innovative solution providers with key industry leaders in microbiome product development.
𝐆𝐮𝐭 𝐌𝐢𝐜𝐫𝐨𝐛𝐢𝐨𝐦𝐞 𝐓𝐫𝐚𝐧𝐬𝐩𝐥𝐚𝐧𝐭 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐏𝐚𝐫𝐤𝐢𝐧𝐬𝐨𝐧'𝐬: 𝐀 𝐍𝐞𝐰 𝐅𝐫𝐨𝐧𝐭𝐢𝐞𝐫 𝐢𝐧 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 A groundbreaking clinical trial in Japan is exploring the potential of gut microbiome transplants to treat Parkinson's disease. By restoring a healthier gut environment, researchers hope to improve treatment outcomes and potentially even uncover new insights into the disease's underlying mechanisms. This aligns with the insights being shared at the 𝐌𝐢𝐜𝐫𝐨𝐛𝐢𝐨𝐦𝐞 𝐌𝐨𝐯𝐞𝐦𝐞𝐧𝐭 𝐄𝐮𝐫𝐨𝐩𝐞 𝐒𝐮𝐦𝐦𝐢𝐭, where we will discuss the role of microbiota in Alzheimer's disease. Key findings include: - 𝐆𝐮𝐭 𝐌𝐢𝐜𝐫𝐨𝐛𝐢𝐨𝐭𝐚 𝐂𝐨𝐦𝐩𝐨𝐬𝐢𝐭𝐢𝐨𝐧: The specific bacteria in our gut can significantly impact the development and progression of neurodegenerative diseases. - 𝐌𝐞𝐜𝐡𝐚𝐧𝐢𝐬𝐦𝐬: Dysfunctional gut microbiota may contribute to these conditions through inflammation, immune system imbalances, and even neurotransmitter production. - 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐏𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥: Identifying unique microbial signatures could revolutionize early diagnosis and personalized treatment for neurodegenerative diseases. The clinical trial in Japan, along with the leading research being presented at the summit, highlights the promising potential of targeting the gut microbiome to address neurodegenerative disorders. This approach offers a new avenue for developing innovative therapies and improving the lives of millions affected by these debilitating conditions. Link to article: https://lnkd.in/dqSaUe3F #GutMicrobiome #NeurodegenerativeDiseases #ParkinsonsDisease #AlzheimersDisease #MicrobiomeMovementEurope #MedicalResearch #Healthcare #Innovation #MicrobiomeMovement
Parkinson’s patients to receive gut bacteria transplants, in clinical first for Japan
https://asianews.network
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Significant overlaps in microbial signatures of SLE and IBD - new therapeutic targets?
Partnership Director | Bioprocessing 🦠 Connecting innovative solution providers with key industry leaders in microbiome product development.
New study reveals the gut microbiome's central role in #autoimmune diseases! 🦠🔍 Researchers have identified significant overlaps in the microbial signatures of SLE and IBD, suggesting shared mechanisms. This groundbreaking discovery opens doors for targeted therapies based on gut bacteria. Key findings: - Distinct #microbial profiles for each autoimmune condition, highlighting the microbiome's diverse roles. - Interactions between gut #bacteria and host signaling pathways, providing potential therapeutic targets. This study paves the way for #personalizedmedicine and innovative treatments for autoimmune diseases. With an everchanging landscape, you can expect to uncover novel #mechanistic data for various disease types, even beyond the gut, at the 9th Annual #MicrobiomeMovement Europe Summit. Message me for more info. Link to article: https://lnkd.in/dcupvVzV
Lupus and inflammatory bowel disease share a common set of microbiome features distinct from other autoimmune disorders - PubMed
pubmed.ncbi.nlm.nih.gov
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Real World Study of Recurrent CDI Therapy Demonstrates Efficacy, Safety (Ferring)
Partnership Director | Bioprocessing 🦠 Connecting innovative solution providers with key industry leaders in microbiome product development.
Real World Study of Recurrent Clostridioides difficile Therapy Demonstrates Efficacy, Safety. Ferring Pharmaceuticals shares results from its outpatient study examining its treatment, Rebyota (#LBP), for the prevention of recurrence. Key notes: - 59 patients completed the 8-week follow up period. 75% had no #CDI recurrence - No adverse events reported with treatment apart from minor leakage during administration in 4 patients (6.2%) Rebyota, whilst gaining FDA approval in the United States, hasn't yet received market access in Europe perhaps due to more stringent regulations around this novel modality and from my conversations, has been making #investment challenging. There will be no better opportunity than the 9th Annual Microbiome Movement Europe Summit to tackle investor engagement with our panel of experts at SOSV, M Ventures , Seventure Partners, Corundum Systems Biology, & EIT Health, gain regulatory insights on new EU SoHO Regulation and Proposed Pharmaceutical Legislation by Céline Druart, and trigger the potential for investment in 2025. View the full agenda: https://ter.li/2s1of8 #MicrobiomeMovement #Regulation #LBP #FMT #Probiotics #Microbiome Pop me a message if you have any questions, or email me at: mehmet.gul@hansonwade.com Fionnuala Lane Eris Ejupi Kelly Cassidy
Full Event Guide | 9th Microbiome Movement Summit Europe
microbiome-europe.com
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Clinical excitement in microbiome drug development from Microbiotica and MaaT Pharma...
Partnership Director | Bioprocessing 🦠 Connecting innovative solution providers with key industry leaders in microbiome product development.
Clinical #Microbiome News: What a week it's been for microbiome drug development in Europe... - 𝐌𝐢𝐜𝐫𝐨𝐛𝐢𝐨𝐭𝐢𝐜𝐚 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐅𝐢𝐫𝐬𝐭 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐃𝐨𝐬𝐞𝐝 𝐢𝐧 𝐢𝐭𝐬 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐏𝐡𝐚𝐬𝐞 𝟏𝐛 𝐓𝐫𝐢𝐚𝐥, 𝐌𝐄𝐋𝐎𝐃𝐘-𝟏 𝐨𝐟 𝐌𝐁𝟎𝟗𝟕 𝐏𝐫𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐌𝐢𝐜𝐫𝐨𝐛𝐢𝐨𝐦𝐞 𝐂𝐨-𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐢𝐧 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐌𝐞𝐥𝐚𝐧𝐨𝐦𝐚 Link to article: https://lnkd.in/eN4UHxMu - 𝐌𝐚𝐚𝐓 𝐏𝐡𝐚𝐫𝐦𝐚 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞𝐬 𝐑𝐞𝐜𝐫𝐮𝐢𝐭𝐦𝐞𝐧𝐭 𝐨𝐟 𝐢𝐭𝐬 𝐀𝐑𝐄𝐒 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐌𝐚𝐚𝐓𝟎𝟏𝟑 𝐭𝐨 𝐓𝐫𝐞𝐚𝐭 𝐀𝐜𝐮𝐭𝐞 𝐆𝐫𝐚𝐟𝐭-𝐯𝐞𝐫𝐬𝐮𝐬-𝐇𝐨𝐬𝐭 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 Link to article: https://lnkd.in/efShNj7W Hear from both Microbiotica and MaaT Pharma at the Microbiome Movement Summit in Europe this January to de-risk your jump to the clinic, tackle challenges in investor engagement, and take home learnings from leading organizations driving the charge in microbiome therapeutic development.
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Partnership Director | Bioprocessing 🦠 Connecting innovative solution providers with key industry leaders in microbiome product development.
I'm proud to announce I will be leading the Partnerships for our Microbiome Movement EU Summit taking place between 28 - 30 January, 2025 in Barcelona, Spain! The European microbiome industry has seen a lot of recent clinical excitement including: - Infant Bacterial Therapeutics AB phase III study shows no significant effects on the primary endpoints but a significant reduction in the secondary endpoint, all-cause mortality - Microbiotica in the U.K. secured additional funding to complete the COMPOSER-1 phase 1 study to treat #UlcerativeColitis and is expecting results at the end of 2025 - Exeliom Biosciences in France is running 3x trials and dosing #LBP in combination with nivolumab in #immunooncology and is expecting results in the next 2 years 𝗛𝗢𝗪𝗘𝗩𝗘𝗥: LBPs are the main area of focus for microbiome drug developers, and as an emerging modality & with no approvals and difficulty of market access for US-approved products in Europe, the regulatory landscape is uncertain and making #investment is challenging. We will be bringing all the right senior stakeholders under one roof (Investors, large pharma, leading LBP developers, academic innovators of microbial modalities, and consumer-focused microbiome industry members) at the start of the year to trigger the potential for investment. For more information, view the website here: https://ter.li/54oiq3 Alternatively, share this with your network, and drop me a message if you're interested in learning more. Thanks everyone - looking forward to this one! Best, Mehmet 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀𝗵𝗶𝗽 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 | 𝗕𝗶𝗼𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴 𝗠𝗶𝗰𝗿𝗼𝗯𝗶𝗼𝗺𝗲 𝗠𝗼𝘃𝗲𝗺𝗲𝗻𝘁 𝗛𝗮𝗻𝘀𝗼𝗻 𝗪𝗮𝗱𝗲 𝗚𝗿𝗼𝘂𝗽 #Microbiome #MicrobiomeMovement
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Only one week left until the 𝟵𝒕𝒉 𝑴𝒊𝒄𝒓𝒐𝒃𝒊𝒐𝒎𝒆 𝑴𝒐𝒗𝒆𝒎𝒆𝒏𝒕 𝑫𝒓𝒖𝒈 𝑫𝒆𝒗𝒆𝒍𝒐𝒑𝒎𝒆𝒏𝒕 𝑺𝒖𝒎𝒎𝒊𝒕 returns to 📍 Boston! Don't miss your chance to join EnteroBiotix, Freya Biosciences & Genome & Company and stay ahead of the curve to robustly prove clinical efficacy as regulator and investor scrutiny necessitates more compelling data than ever before. It’s also the 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲’𝐬 𝐩𝐫𝐞𝐦𝐢𝐞𝐫 𝐩𝐥𝐚𝐭𝐟𝐨𝐫𝐦 𝐟𝐨𝐫 𝐜𝐨𝐧𝐧𝐞𝐜𝐭𝐢𝐨𝐧-𝐛𝐮𝐢𝐥𝐝𝐢𝐧𝐠 𝐢𝐧 𝟮𝟬𝟮𝟰 – so don’t miss out! 🤝 📣 𝐅𝐈𝐍𝐀𝐋 𝐅𝐄𝐖 𝐏𝐀𝐒𝐒𝐄𝐒 𝐀𝐕𝐀𝐈𝐋𝐀𝐁𝐋𝐄! Grab your spot now before it's too late: https://ter.li/jeaydv
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"One of the most exciting opportunities of working in an emerging field is that you're in this pre-competitive space where there's a lot of community and collaboration. We really need one another in this community to become successful, whether it's the manufacturers or the data scientists or any of the service companies needed." says Nikole Kimes, PhD, Founder & Chief Executive Officer at 𝐒𝐢𝐨𝐥𝐭𝐚 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬. 📣With the 𝟗𝒕𝒉 𝑴𝒊𝒄𝒓𝒐𝒃𝒊𝒐𝒎𝒆 𝑴𝒐𝒗𝒆𝒎𝒆𝒏𝒕 - 𝑫𝒓𝒖𝒈 𝑫𝒆𝒗𝒆𝒍𝒐𝒑𝒎𝒆𝒏𝒕 𝑺𝒖𝒎𝒎𝒊𝒕 kicking off in less than 𝟮 𝐰𝐞𝐞𝐤𝐬, we had the pleasure of speaking with Nikole about the importance of collaboration in the microbial therapeutics industry, the promising areas and biggest hurdles in the microbiome field, and what the industry can learn from recent clinical progress. She also shared her excitement for data sessions at the upcoming summit! 🎉 View the summit details here in detail ➡️ https://ter.li/aohofr The summit is just around the corner! 𝐒𝐞𝐜𝐮𝐫𝐞 𝐲𝐨𝐮𝐫 𝐭𝐢𝐜𝐤𝐞𝐭𝐬 𝐧𝐨𝐰 🎟 to gain the latest insights from industry leaders like Nikole E. Kimes and organizations such as Freya Biosciences, MRM Health, FDA and many more! — don't miss out! Register here ➡️ https://ter.li/wy4u0i