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SYN-010

Phase 2

Irritable Bowel Syndrome With Constipation (IBS-C) | Small molecule | Gastrointestinal |Theriva Biologics, Inc.|Last Updated: Nov 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment117

FDA Designations

No designations recorded

Clinical trial landscape

SYN-010 · 2 trials · 1 indication

Phase 2 2
NCT02493036A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-CIrritable Bowel Syndrome With Constipation (IBS-C)
COMPLETED54 Analytics
NCT02495623A Study of the Effect of SYN-010 on Subjects With IBS-CIrritable Bowel Syndrome With Constipation (IBS-C)
COMPLETED63 Analytics
PHASE2COMPLETED
A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C
Irritable Bowel Syndrome With Constipation (IBS-C)
NCT0249303654
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PHASE2COMPLETED
A Study of the Effect of SYN-010 on Subjects With IBS-C
Irritable Bowel Syndrome With Constipation (IBS-C)
NCT0249562363
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Study Endpoints

Primary Endpoints

Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose.
56 days
Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7
7 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
High Dose SYN-010EXPERIMENTAL42-mg SYN-010
Low DoseACTIVE_COMPARATOR21 mg SYN-010
High DoseACTIVE_COMPARATOR42 mg SYN-010
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
SYN-010DRUG -
SYN-010 21 mgDRUG -
SYN-010 42 mgDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Subject has completed Study SB-2-010-001. * Subject must be willing to abstain from or discontinue the use of any laxatives and any prescription and over-the-counter medications or supplements intended to treat constipation from the time of Screening to the end of the study, e...

Countries:United States
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Frequently asked questions about SYN-010

What is SYN-010 used for?

SYN-010 is an investigational small molecule being developed for the treatment of Irritable Bowel Syndrome With Constipation (IBS-C). It is currently in Phase 2 clinical development and has not been approved by the FDA. Two Phase 2 trials have been completed in the United States.

Who makes SYN-010?

SYN-010 is being developed by Theriva Biologics, Inc., a company traded on the stock exchange under the ticker symbol TOVX. The drug is an investigational small molecule intended for the treatment of Irritable Bowel Syndrome With Constipation (IBS-C).

What phase is SYN-010 in?

SYN-010 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 clinical trials have been completed, both in the United States, studying the drug in patients with Irritable Bowel Syndrome With Constipation (IBS-C).

What clinical trials has SYN-010 been in?

SYN-010 has been studied in two completed Phase 2 clinical trials. The first, NCT02493036, evaluated the sustainability of effects in 54 patients with IBS-C. The second, NCT02495623, studied the effect of SYN-010 on 63 subjects with IBS-C. Both trials were conducted in the United States.

Is SYN-010 a randomized, double-blind, placebo-controlled trial?

Yes, SYN-010 clinical trials are randomized, double-blind, and placebo-controlled. The two completed Phase 2 trials enrolled a total of 117 patients with Irritable Bowel Syndrome With Constipation (IBS-C). The trials were not biomarker-selected and included adult patients aged 18 years and older.