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Also known as Sacrosidase Oral Solution
Sacrosidase · 1 trial · 1 indication
The numeric value of the Total Symptom Score (TSS) is derived from the Daily Symptom Questionnaire (DSQ). The DSQ consisted of rating the frequency in the last 24 hours and the severity of 7 symptoms, abdominal bloating, abdominal pain, abdominal cramps, abdominal gas/flatulence, constipation, nausea, and diarrhea. The daily symptom score is calculated by summing the frequency and severity scores for each symptom with a minimum daily score of 0 and a maximum daily score of 98. The TSS is calculated by averaging the combined daily symptom scores during a 7-day period for baseline and 1-week post-intervention during each treatment period and ranges from 0-98, with higher values representing a worse outcome.
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Subjects will be randomized to take active treatment, sacrosidase, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) during either Treatment Period 1 or Treatment Period 2. The study treatment period is one week. |
| Placebo | PLACEBO_COMPARATOR | Subjects will be randomized to take placebo treatment, sacrosidase placebo, 2 mL (17,000 IU) with every meal or snack, administered orally following dilution with 2 to 4 ounces (60 to 120 mL) of water or milk (either cold or at room temperature) during either Treatment Period 1 or Treatment Period 2. The study treatment period is one week. |
| Name | Type | Description |
|---|---|---|
| Sacrosidase Oral Solution | DRUG | Study drug |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Ability to comprehend and provide a signed and dated informed consent form * Stated willingness to comply with all study procedures and attend all scheduled clinic visits, and continue participation for the duration of the study * Ability to self-administer oral medication and...
Sacrosidase is being studied for fructan intolerance, a condition in which people have difficulty digesting fructans, a type of carbohydrate found in foods such as wheat, onions, and garlic. It is an oral solution and is not yet approved for this use; it remains in clinical development.
Sacrosidase is being developed by Evoke Pharma, Inc., which trades under the ticker EVOK. The company is evaluating the oral solution in patients with fructan intolerance.
Sacrosidase is in Phase 2 development. A single Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for fructan intolerance.
Sacrosidase has been studied in one completed Phase 2 trial, NCT05703009, titled Effects of Sacrosidase and Placebo in Subjects With Fructan Intolerance. The trial enrolled 25 adults in the United States and was randomized, double-blind, and placebo-controlled.
Yes. Sacrosidase oral solution is another name for sacrosidase, the investigational oral treatment being developed by Evoke Pharma for fructan intolerance. Both names refer to the same product.