Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Surotomycin
CB-183,315 · 5 trials · 3 indications
The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
The number of participants with an Investigator-assessed clinical response of cure is presented. The information to assess clinical response was collected at any time up to and including Day 19.
The number of participants with investigator assessed clinical response of failure or unable to evaluate is presented. Clinical response was determined by the participant's condition on the second day following the last dose of study medication, unless considered a treatment failure. Treatment failures were assessed whenever they occurred and were carried forward to the end-of-treatment (EOT). The information to assess clinical response was collected at any time up to and including Day 19.
| Arm | Type | Description |
|---|---|---|
| CB-183,315 | EXPERIMENTAL | Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days. |
| Vancomycin | ACTIVE_COMPARATOR | Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days. |
| Surotomycin | EXPERIMENTAL | 250 mg Surotomycin over- encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days |
| CB-183,315, 125 mg | EXPERIMENTAL | 125 milligrams (mg) CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days. |
| CB-183,315, 250 mg | EXPERIMENTAL | 250 mg CB 183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days. |
| Vancomycin, 125 mg | ACTIVE_COMPARATOR | 125 mg vancomycin administered orally four times a day for 10 days. |
| Surotomycin 0.5 g | EXPERIMENTAL | Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
| Surotomycin 1 g | EXPERIMENTAL | Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
| Surotomycin 2 g | EXPERIMENTAL | Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
| Placebo | PLACEBO_COMPARATOR | Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
| Surotomycin 4 g | EXPERIMENTAL | A single oral dose of 4 g surotomycin in hard gelatin capsules |
| Name | Type | Description |
|---|---|---|
| CB-183,315 | DRUG | CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule. |
| Vancomycin | DRUG | Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule. |
| Placebo | DRUG | Placebo size 00 opaque hard gelatin capsules. |
| Surotomycin | DRUG | 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days |
Inclusion Criteria: * Is able to read and sign a consent form; * Is from ≥18 to \<90 years of age; * Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device; * Tests positive for Clostridium difficile; * If female, must not be pregnant or nursing and take a...
CB-183,315 is an investigational small molecule developed for the treatment of Clostridium difficile infection, a bacterial infection of the gut. It is being studied in adults 18 years and older with Clostridium difficile associated diarrhea. It has not been approved for commercial use and remains in clinical development.
CB-183,315 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating the drug in Clostridium difficile infection. The compound is a small molecule therapeutic in the infectious disease area.
CB-183,315 has reached Phase 3 clinical development. Two trials have been completed, one Phase 2 and one Phase 3, and no trials are currently active. The drug is investigational and has not been approved by the FDA for the treatment of Clostridium difficile infection.
CB-183,315 has been studied in two completed trials. NCT01598311 was a Phase 3 study in participants with Clostridium difficile associated diarrhea, enrolling 608 adults. NCT01085591 was a Phase 2 study in participants with Clostridium difficile infection and diarrhea, enrolling 210 adults in the United States and Canada.
Both CB-183,315 trials were randomized and double blind, and the Phase 3 study used an active control comparator. Together the two completed trials enrolled 818 participants aged 18 years and older, with both men and women eligible. Neither trial selected participants based on a biomarker.