Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017
Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.
RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.
RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.
This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.
RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.
“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”
The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH CD2).
“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”
RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”
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The observational study, which was conducted at four hospitals in New York City, examined more than 100,000 pairs of patients who sequentially occupied a given hospital bed at one of the facilities from 2010 to 2015.
Patients wereexcluded from the study if they developed CDI within 48 hours of admission, or if the prior hospital bed occupant was in the bed for less than 24 hours. The intent of the study was to determine whether antibiotic treatment in the initial bed occupant had any impact in CDI rates in subsequent patients.
Overall, there were 576 pairs in which the second hospital bed patient developed CDI within 2 to 14 days of admission—0.57% of the total number of patient pairs observed. The patients who developed CDI were more likely to have traditional CDI risk factors, such as older age, increased creatinine, and decreased albumin.
But the cumulative incidence of CDI was higher when the prior bed occupants had been treated with antibiotics (0.72%) than when they received no antibiotics (0.43%). In the final analysis, CDI was 22% more likely in patients who occupied a bed in which the prior occupant received an antibiotic.
In fact, when researchers considered other potential risk factors for CDI in the prior bed occupants—including treatment with acid-suppression medications and immune suppressants—antibiotic use was the only factor associated with increased risk for CDI in subsequent patients. And the association remained after the researchers excluded the patient pairs in which the prior patient had recent CDI.
Antibiotics add to colonization pressure
The findings add another layer to our knowledge of how antibiotics can increase susceptibility to CDI, which causes an estimated 500,000 illnesses and
Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile. Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections (CDI) a year in the United States.
It’s already well established that treating patients with antibiotics increases risk for CDI by eliminating the good bacteria that keep C difficile in check or increasing bacteria that facilitate it. Previous studies have shown that antibiotic prescribing in individual hospital wards and in hospitals in general can also be associated with increased C difficile risk.
This study, though it only demonstrates a correlation, shows how antibiotics given to other patients may affect the local microenvironment and add to colonization pressure.
“In patients colonized by C difficile, antibiotics may promote C difficile proliferation and the number of C difficile spores that are shed into the local environment,” the authors write. “In turn, this may result in a higher environmental burden of C difficile and greater risk for acquisition and infection in future patients who share the same environment.”
Promoting C difficile proliferation and shedding is significant, the authors add, because C difficile spores can persist in hospital room surfaces for months + and are easily transferred from patient to patient.
Because C difficile can spread so quickly and stronger strains are emerging, the Centers for Disease Control and Prevention have labeled the bacteria an urgent public health threat. The White House National Action Plan for Combating Antibiotic-Resistant Bacteria has set a goal of reducing CDI by 50% by the year 2020.
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“C. diff. Spores and More,” Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses
This week’s episode——
“The Direct Impact On Mental Health Caused By Physical Illness and Personal Losses”
With Our Guest, Cheryl Jones, M.S., M.F.T., A grief counselor, a cancer educator and C. diff. survivor.
Tuesday, April 19th at the following times
10 a.m. Pacific Time 11 a.m. Mountain Time 12 p.m. Central Time 1 p.m. Eastern Time
Join us with our guest,Cheryl Jones, M.S., M.F.T., as we discuss anxiety, depression, and grief. Chronic physical illness, also defined as a medical condition that lasts for a year or more, has been experienced by many individuals diagnosed with a C. difficile infection. Patients can become depleted in patience and tolerance from an illness, resulting in a disruption of normal day to day activities due to limited mobility and/or loss of in dependency or from the loss of a loved one. The individual may experience feelings of frustration, anger and even grief. A sense of hopelessness may follow. Like other chronic medical conditions, individuals diagnosed with C. diff.,are also at risk for developing clinical depression and anxiety. Listen in as Cheryl provides information educating those who are struggling through physical limitations and personal losses.
Our Guest: Cheryl Jones is a grief counselor and a cancer educator who hosts Good Grief radio on the VoiceAmerica network. During her education as a Marriage and Family Therapist, her first wife was diagnosed with Multiple Myeloma, which was at the time a uniformly terminal illness with a six month to one-year prognosis. In the eight + years that followed, Cheryl engaged daily in the work of preparing for her death. They worked closely with Stephen and Ondrea Levine (Who Dies and Grieving Into Life and Death), learning to live with uncertainty. After her wife’s death in 1995, Cheryl immersed herself in her own multifaceted grief, surprised by frequent moments of joy.
Cheryl is a consultant and group leader at the Women’s Cancer Resource Center (Oakland, CA), where she developed, manages and teaches in their Cancer, Illness and End of Life Continuing Education program. She also presents workshops integrating the arts, most particularly music, into explorations of grief.