ExeGi Pharma's EXE-346 Shows Promising Results in Phase 1b Clinical Trials for Excessive Stool Frequency
ExeGi Pharma LLC, a biotech firm specializing in live biotherapeutic drugs and probiotics, has unveiled encouraging topline data from the Phase 1b segment of its ongoing PROF study focused on its innovative product, EXE-346. This new treatment targets individuals who have undergone an ileal pouch-anal anastomosis (IPA) procedure, often performed on patients dealing with chronic ulcerative colitis. The J-pouch procedure aims to restore normal bowel function without needing an external colostomy bag, but many patients find themselves facing the challenge of excessive bowel movements—often exceeding 10 times a day.
The PROF study's goal is to evaluate the safety of EXE-346 while measuring its efficacy at alleviating excessive stool frequency and nighttime awakenings, a common issue for these patients. Following a four-week trial involving a significant daily intake of 3,000 billion live probiotics, results showed a noteworthy 18% reduction in the average daily bowel movements, dropping from 13.09 to 10.69. More impressively, there was a 28% decrease in nighttime awakenings, decreasing from an average of 2.39 to 1.73. Importantly, no serious side effects were reported during the trial, affirming the product's safety profile.
Dr. Hans Herfarth, director of the University of North Carolina Multidisciplinary IBD Center, expressed optimism regarding these early findings. "We are pleased with the favorable results in terms of both safety and efficacy for the EXE-346 product," he stated. He emphasized the importance of these initial results in paving the way for the next Phase 2 trial, which aims to evaluate effectiveness through placebo-controlled methods. This new phase of the study is set to commence in January 2025, with plans to recruit participants from eight clinical sites spread across the United States.
Understanding the context of excessive bowel movements in J-pouch patients further highlights the impact of EXE-346. After undergoing a J-pouch procedure, patients often struggle with frequent bowel movements that can disrupt their daily lives and sleep patterns. The struggle is not trivial—many patients report waking up multiple times at night to manage their symptoms, significantly affecting their quality of life. Therefore, the 18% reduction in daily movements and the marked decrease in nighttime awakenings represent a significant advance in the management of this challenging condition.
ExeGi Pharma’s development of EXE-346 underscores its commitment to enhancing the lives of those affected by gastrointestinal disorders. EXE-346 is a specifically formulated live biotherapeutic product (LBP) composed of eight powerful strains of probiotic bacteria prepared in high doses. Reared under strict biologic-grade cGMP standards, this formulation aims to provide robust support for those with severe bowel irregularities.
The commitment of ExeGi Pharma to science-backed innovations is also evident in its holistic business approach, combining clinical research with a strong stance on environmental sustainability. The firm aspires to deliver clinical solutions not just for immediate health needs, but also with longer-term environmental responsibilities in mind.
As the industry anticipates the results from the upcoming Phase 2 trials, the learnings from the initial Phase 1b study provide a foundation of hope for numerous patients grappling with frequent bowel issues. Early results such as these are a potential beacon of light for future treatments, paving the way towards more effective management options for patients with J-pouches, thus improving their overall quality of life.
The PROF study's goal is to evaluate the safety of EXE-346 while measuring its efficacy at alleviating excessive stool frequency and nighttime awakenings, a common issue for these patients. Following a four-week trial involving a significant daily intake of 3,000 billion live probiotics, results showed a noteworthy 18% reduction in the average daily bowel movements, dropping from 13.09 to 10.69. More impressively, there was a 28% decrease in nighttime awakenings, decreasing from an average of 2.39 to 1.73. Importantly, no serious side effects were reported during the trial, affirming the product's safety profile.
Dr. Hans Herfarth, director of the University of North Carolina Multidisciplinary IBD Center, expressed optimism regarding these early findings. "We are pleased with the favorable results in terms of both safety and efficacy for the EXE-346 product," he stated. He emphasized the importance of these initial results in paving the way for the next Phase 2 trial, which aims to evaluate effectiveness through placebo-controlled methods. This new phase of the study is set to commence in January 2025, with plans to recruit participants from eight clinical sites spread across the United States.
Understanding the context of excessive bowel movements in J-pouch patients further highlights the impact of EXE-346. After undergoing a J-pouch procedure, patients often struggle with frequent bowel movements that can disrupt their daily lives and sleep patterns. The struggle is not trivial—many patients report waking up multiple times at night to manage their symptoms, significantly affecting their quality of life. Therefore, the 18% reduction in daily movements and the marked decrease in nighttime awakenings represent a significant advance in the management of this challenging condition.
ExeGi Pharma’s development of EXE-346 underscores its commitment to enhancing the lives of those affected by gastrointestinal disorders. EXE-346 is a specifically formulated live biotherapeutic product (LBP) composed of eight powerful strains of probiotic bacteria prepared in high doses. Reared under strict biologic-grade cGMP standards, this formulation aims to provide robust support for those with severe bowel irregularities.
The commitment of ExeGi Pharma to science-backed innovations is also evident in its holistic business approach, combining clinical research with a strong stance on environmental sustainability. The firm aspires to deliver clinical solutions not just for immediate health needs, but also with longer-term environmental responsibilities in mind.
As the industry anticipates the results from the upcoming Phase 2 trials, the learnings from the initial Phase 1b study provide a foundation of hope for numerous patients grappling with frequent bowel issues. Early results such as these are a potential beacon of light for future treatments, paving the way towards more effective management options for patients with J-pouches, thus improving their overall quality of life.
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