Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Surotomycin · 3 trials · 2 indications
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).
| Arm | Type | Description |
|---|---|---|
| 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 |
| Vancomycin | ACTIVE_COMPARATOR | 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, 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 |
|---|---|---|
| Surotomycin | DRUG | 250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days |
| Vancomycin | DRUG | 125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days |
| Placebo | DRUG | Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days |
To be included in this study, participants must: * Sign a consent form; * Be \>= 18 and \< 90 years of age; * Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device; * Test positive for Clostridium difficile; * If female, must not be pregnant or nursing a...
Surotomycin is an investigational small molecule being developed for Clostridium difficile associated diarrhea (CDAD) and Clostridium difficile infection. It is being studied in patients with these conditions, and clinical trials have also evaluated it in healthy participants.
Surotomycin is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company has sponsored clinical trials of the drug in Clostridium difficile infection and CDAD.
Surotomycin is in Phase 1 clinical development. It has completed Phase 1 trials in healthy participants, and a Phase 3 trial in patients with Clostridium difficile infection has also been completed. The drug remains investigational and is not approved.
Surotomycin has been studied in three completed trials. NCT01597505 was a Phase 3 study in 606 participants with Clostridium difficile infection. NCT02835105 and NCT02835118 were Phase 1 studies of ascending single and multiple doses in healthy participants, with 40 and 30 enrollees respectively.
Yes, Surotomycin is also known as CB-183,315. One of its clinical trials, NCT01597505, is titled "Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)," confirming that both names refer to the same drug.
Yes, Surotomycin has been tested in healthy volunteers. Two Phase 1 trials, NCT02835105 and NCT02835118, evaluated ascending single and multiple oral doses of the drug in healthy participants, with enrollments of 40 and 30 individuals respectively.