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MD-7246

Phase 2

Irritable Bowel Syndrome With Diarrhea (IBS-D) | Small molecule | Gastrointestinal |Ironwood Pharmaceuticals, Inc.|Last Updated: Mar 12, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment515
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03931785A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel SyndromePHASE2 COMPLETED 515May 1, 2019Mar 11, 2020Mar 12, 202180 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
Baseline, up to Week 12 (end of the Treatment Period)

Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.

Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
Baseline through Week 12

A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with \< 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MD-7246 300 μgEXPERIMENTAL1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
MD-7246 600 μgEXPERIMENTAL2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
MD-7246 1200 μgEXPERIMENTAL4 MD-7246 300-μg oral tablets
PlaceboPLACEBO_COMPARATOR4 matching placebo oral tablets
Interventions
NameTypeDescription
MD-7246DRUGOral tablet
PlaceboDRUGMatching oral tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites80

Inclusion Criteria: * Patient meets the Rome IV criteria for diagnosis of IBS-D * Patient maintains a minimum level of compliance with daily diary * Female patients of childbearing potential must agree to use one of the following methods of birth control: 1. Hormonal contraception 2. Double-ba...

Countries:United States
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