Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MHS-1031 · 1 trial · 1 indication
The difference between baseline weekly average heartburn-free days and weekly average heartburn-free days during Treatment Phase Weeks 1-4 and Weeks 5-8 (as measured using questions 1, 2 and 3 of the Reflux Symptom Questionnaire Electronic Diary) (RESQ-eD).
| Arm | Type | Description |
|---|---|---|
| Drug Product | ACTIVE_COMPARATOR | Panosyl-isomaltooligosaccharide (PIMO) liquid 1 g (1.5 ml) per day for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo liquid (1.5 ml) per day for 8 weeks |
| Name | Type | Description |
|---|---|---|
| MHS-1031 | DRUG | Study medication will be supplied as a syrup in individual sachets containing 1g (1.5 mL) of MHS-1031. Subjects will be randomized in 2:1 fashion to either study drug (2) or placebo (1) |
| Placebo | OTHER | Matching placebo is an oral solution formulated to have a degree of sweetness and acidity similar to the study medication and will be provided in equivalent sachets containing 1.5g (1.5 mL) of the oral placebo solution. |
Inclusion Criteria: * In the opinion of the investigator or sub-investigators, the subject is capable of understanding and complying with protocol requirements, including compliance with completing nightly online questionnaires in one of the IRB-approved languages. * Subject signs and dates an elec...
MHS-1031 is an investigational small molecule being developed for the treatment of Gastroesophageal Reflux (GERD). It is intended to be used as an adjunctive therapy to proton pump inhibitor (PPI) therapy. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MHS-1031 is a small molecule being studied as an adjunctive therapy to proton pump inhibitors (PPIs) for Gastroesophageal Reflux. Its specific molecular target has not been disclosed in available clinical trial information. The ongoing Phase 2 trial is evaluating its efficacy and safety in combination with PPI therapy.
MHS-1031 is being developed by Catalyst Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CPRX. The company is conducting a Phase 2 clinical trial of MHS-1031 for Gastroesophageal Reflux in the United States.
MHS-1031 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is active but not recruiting participants, with an estimated enrollment of 247 patients.
MHS-1031 is being studied in a Phase 2 clinical trial registered as NCT05556824, titled "Multi-Center Study of Panosyl-Isomaltooligosaccharides Adjunctive to PPI Therapy to Treat GERD." This randomized, double-blind, placebo-controlled trial is enrolling 247 adults aged 18 years and older in the United States.
MHS-1031 is also known as Panosyl-Isomaltooligosaccharides, based on the clinical trial title. The Phase 2 study NCT05556824 evaluates this compound as an adjunctive therapy to proton pump inhibitors for Gastroesophageal Reflux. The drug is being developed by Catalyst Pharmaceuticals under the name MHS-1031.