SAN FRANCISCO, July 20, 2020 /PRNewswire/ -- Pendulum Therapeutics, an evidence-based microbiome company, announced today the publication of their clinical study in the journal BMJ Open Diabetes Research & Care showing the effectiveness of Pendulum's novel medical probiotic, Pendulum Glucose Control. The published study demonstrates both clinically and statistically significant improvements to A1C and blood glucose spikes in people with type 2 diabetes taking metformin, and demonstrates the ability of Pendulum's novel probiotic strains to provide dietary management of blood glucose control through the gut microbiome.
The multi-site, double-blinded, placebo-controlled, randomized, nutrition study was performed in people with type 2 diabetes on a background of diet and exercise alone or in combination with metformin. Results demonstrated a statistically significant improvement in A1C and blood glucose control after 12-week administration of Pendulum's novel synbiotic formulation, Pendulum Glucose Control. The key endpoint for assessing metabolic effect was changes in blood glucose spikes after a meal in subjects receiving the medical probiotic formulation compared to those receiving placebo, in addition to assessing safety and tolerability. At 12 weeks, the data showed that those who received Pendulum's formulation experienced a 32.5 percent decrease in post-meal blood glucose spikes (AUC) and a 0.6 percent decrease in hemoglobin A1C relative to placebo. The product was well-tolerated and no safety issues were observed in the study.
"The research demonstrates that the administration of microbial species, selected for their known beneficial functions in the microbiome, is a promising new tool that augments the traditional dietary measures for improving glucose control in type 2 diabetes, and it is well established that improved glucose control reduces the risk for the devastating long-term complications of diabetes," said Orville Kolterman, M.D., chief medical officer, Pendulum Therapeutics, and senior author of the study.
Through their proprietary discovery platform, Pendulum was able to identify fully DNA-sequenced, novel strains of probiotics and characterize their microbial mechanisms of action. The targeted strains in Pendulum Glucose Control are designed to replenish lost functions within the gut microbiome observed in people with type 2 diabetes, by helping to metabolize fiber and produce butyrate, a short-chain fatty acid that binds to G-protein coupled receptors to stimulate GLP-1 release. GLP-1 is a hormone known to decrease post meal glucose spikes and A1C.
Pendulum Glucose Control is the first and only clinically shown medical probiotic designed specifically for the dietary management of type 2 diabetes. The patented formulation contains five strains of anaerobic bacteria, including Clostridium beijerinckii WB-STR-0005, Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Eubacterium hallii WB-STR-0008, Bifidobacterium infantis 100 as well as a prebiotic. This unique formulation of beneficial bacteria and prebiotic is not currently available in any probiotic marketed today. Each of the microbes in Pendulum Glucose Control have been fully characterized and have been reviewed and affirmed as GRAS (Generally Recognized as Safe) by an independent third-party organization.
"The link between health, metabolism and the gut microbiome is generating a high level of interest and scientific research," said Carol Wysham, MD, Clinical Professor of Medicine, Clinical Endocrinologist and President Elect of the Endocrine Society. "We are only just scratching the surface regarding microbiome-based interventions that have the ability to improve health. These interventions must pose no safety risks and be backed by solid scientific research. Pendulum is a pioneer in using DNA sequencing technology to develop novel formulations of bacterial strains that target specific deficits in the microbiome associated with metabolic dysfunction."
Pendulum Glucose Control is currently available for purchase online at pendulumlife.com. It is a medical food intended for use only under physician supervision for dietary management of type 2 diabetes and as part of a total diabetes management plan. Pendulum Glucose Control is Non-GMO Project Verified, vegan, dairy-free and gluten-free and capsules are to be taken twice daily with food (both morning and evening).
For more information or to purchase Pendulum Glucose Control, please visit pendulumlife.com.
About Pendulum Therapeutics
Pendulum Therapeutics is the first and only evidence-based microbiome company to apply the discoveries of high-resolution, long-read DNA sequencing to the development and commercialization of microbiome interventions targeting specific diseases. Its flagship product, Pendulum Glucose Control, is the only clinically shown Medical Probiotic providing dietary management through the microbiome to help manage A1C and blood sugar levels in people with type 2 diabetes. Pendulum's proprietary innovation platform enables identification of microbiome mechanisms of action and rapid translation from discovery and development through human clinical validation. Founded in 2012 by a diverse team of scientists with deep microbiology, biochemistry, computational and clinical expertise, Pendulum has raised $57 million to date. Sequoia Capital led its Series B round with repeat participation from Mayo Clinic, True Ventures, Khosla Ventures, AME Cloud Ventures and others. Formerly Whole Biome, Pendulum Therapeutics is headquartered in San Francisco.
Formal press release here.