Pendulum Therapeutics and BiomeSense launch pioneering study on gut microbiome using continuous sampling technology

The fully enrolled 14-week exploratory study is set to conclude Fall 2024

2024-08-23

(Press-News.org)

San Francisco, CA (August 12, 2024) – Pendulum Therapeutics, in collaboration with BiomeSense, announces the launch of an innovative new pilot study entitled "Detection of Akkermansia muciniphila Utilizing Serial Longitudinal Samples with the BiomeSense GutLab™: An Open-Label Proof of Concept Study." Pendulum Therapeutics and BiomeSense are two biotech companies at the forefront of microbiome science. Their groundbreaking research aims to advance the scientific understanding of the human microbiome by focusing on continuous detection of Akkermansia muciniphila, a keystone strain in the gut microbiome, using a new data generation technology.

About the Study: The study leverages the GutLab™system, a cutting-edge automated laboratory, which enables continuous tracking of the gut microbiome in the comfort of study participant’s home bathrooms. With the regular collection of this data over many weeks, scientists are able to conduct a full longitudinal stool microbiome analysis and look at changes in Akkermansia levels over the course of the study. Unlike traditional methods that examine the microbiome at fixed points in time, GutLab™ allows for continuous assessment of the microbiome’s composition, based on many samples. By analyzing this data with MetaBiome™’s innovative time-aware algorithms and database, researchers will be able to gain a comprehensive understanding of Akkermansia muciniphila levels in study participants and its impact on their microbiome ecosystems.

Importance of Akkermansia Muciniphila: Akkermansia muciniphila makes up approximately 4% of intestinal bacteria1 and plays a crucial role in regulating the gut mucus lining and key metabolic functions. Its abundance is associated with a stable and diverse gut microbiome. However, its levels can vary and decrease for various reasons. Age, diet, and other lifestyle factors play crucial roles in determining the abundance of Akkermansia. A loss of Akkermansia has been associated with increased intestinal permeability, obesity, inflammation and diabetes. Since its discovery in 2004, over 3,000 studies have highlighted its significance in gut health2 and overall health.

"Akkermansia is often referred to as a keystone strain because it plays such an important role in helping maintain our health and longevity. Being able to measure Akkermansia levels in people over time is a total game-changer for conducting microbiome research and understanding the impact of products like ours." Dr. Adam Perlman, Chief Medical Officer at Pendulum Therapeutics and one of the co-principal investigators of this study.

Study Details: Pendulum, in collaboration with BiomeSense, will conduct this exploratory study measuring Akkermansia in a healthy adult population over 14 weeks, including an 8-week period of administering two dose levels of Akkermansia muciniphila through Pendulum’s dietary supplements: Akkermansia and Akkermansia 500 PRO. This 2-arm, open-label pilot study includes 10 active participants and 5 household controls. The study is fully enrolled and is expected to conclude in fall 2024.

"Partnering with Pendulum Therapeutics allows us to combine our cutting-edge technology with their expertise in probiotics and microbiome health. Together, we are pioneering new frontiers in microbiome science that have the potential to transform how we approach health and disease." Kevin Honaker, Co-founder and CEO of BiomeSense.

Significance of the Study: The GutLab™ and MetaBiome™ platforms have the potential to transform gut health research by providing detailed, continuous data on microbiome changes in humans. Traditional microbiome data generation methods are often cumbersome and only sample the microbiome at single points in time, limiting data generation and insights. With continuous data collection and insights into shifts in microbiome composition, the GutLab™ system has the potential to do for microbiome science what the continuous glucose monitor did for the field of diabetes and understanding glucose trends. The GutLab™offers a convenient at-home solution for continuous microbiome tracking. MetaBiome™’s time-aware algorithms then analyze this data to track changes within an individual's microbiome composition over time, enabling a new dimension of analysis and biomarker discovery.

"The dense longitudinal data collection offered by GutLab™ and MetaBiome™ provides unprecedented insights into the dynamic nature of the gut microbiome. This transformation in data quality and frequency is essential for advancing our understanding of microbiome-related health and disease." Dr. Jack Gilbert, Ph.D., Co-founder of Biomesense and Professor, Associate Vice Chancellor, and Director of the Microbiome and Metagenomics Center at the University of California San Diego.

Study Sponsorship: Pendulum Therapeutics sponsors this study, led by co-principal investigators Dr. Adam Perlman, Pendulum’s CMO, and Dr. Orville Kolterman, Pendulum's emeritus CMO.

Media Contact:

Pendulum@walkerdrawas.com

About Pendulum:

Pendulum Therapeutics is disrupting the health industry. Pioneering the next frontier of microbiome science, the biotech company works to develop revolutionary and effective products that address imbalances in the microbiome, transforming people's lives from the inside out. Led by Colleen Cutcliffe, Co-founder and CEO who received her Ph.D. in Biochemistry and Molecular Biology from Johns Hopkins University, Pendulum was founded in 2012 by a diverse team of scientists with deep microbiology, biochemistry, computational and clinical expertise. In 2024, Colleen Cutcliffe brought on Dr. Adam Perlman as Chief Medical Officer, formerly a Medical Director at Mayo Clinic and Duke University. Investors in the company include Sequoia Capital, True Ventures and the Mayo Clinic. www.pendulumlife.com

About BiomeSense:

BiomeSense was co-founded by Jack Gilbert, Ph.D. and Kevin Honaker, MBA and is a biotechnology company focused on unlocking the gut microbiome as a powerful new avenue of precision medicine. BiomeSense’s pioneering GutLab™automated laboratory system and MetaBiome™ bioinformatics platform are the first-ever solution to provide continuous, at-home tracking & analysis of the microbiome. www.biomesense.com

This press release aims to inform the public about the innovative study by Pendulum Therapeutics and BiomeSense, emphasizing the potential impact on gut health research and the importance of Akkermansia muciniphila in the human microbiome.

1 "ScienceDirect. (n.d.). Akkermansia muciniphila. Retrieved July 30, 2024, from https://www.sciencedirect.com/topics/immunology-and-microbiology/akkermansia-muciniphila

2 Centers for Disease Control and Prevention. (2023). Emerging infectious diseases.

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Pendulum Therapeutics and BiomeSense launch pioneering study on gut microbiome using continuous sampling technology

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