The US Food and Drug Administration (FDA) has reviewed First Wave’s investigational new drug (IND) amendment and is yet to provide any further comments in the 60-day review period after it received a modified protocol.
The planned multi-centre, open-label SPAN trial will evaluate the tolerability, safety, and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study, which will have an estimated 12 patients aged 18 years or older.
The coefficient of fat absorption (CFA) is the study’s primary efficacy endpoint, and secondary endpoints include signs and symptoms of malabsorption, stool weight, and coefficient of nitrogen absorption (CNA).
Patient screening for the trial is expected to start early this month, with topline data anticipated by mid-2023.
The study will involve three clinical trial sites in the US.
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First Wave BioPharma president and CEO James Sapirstein said: “Preclinical research has demonstrated the new adrulipase formulation is able to deliver the drug in the intended area of the gastrointestinal tract, where it can provide the desired therapeutic effect.
“This Phase II clinical trial is designed to test that capability as a key step in our goal to provide patients with a more effective and convenient therapeutic option for EPI associated with cystic fibrosis and chronic pancreatitis.”
The SPAN trial design employs a dose titration strategy. In this trial, patients will be screened at baseline to ensure that they have at least 80% CFA.
Those who are eligible will then be switched from their commercial enzyme product to adrulipase.
Initially, each patient will be given a low adrulipase dose and will be switched to a medium dose, if not clinically controlled.
The patient will be advanced to a high dose if not controlled on a medium dose.
A CFA will be obtained after the titrations are carried out over a three-week period and end of study CFAs will be compared to the baseline CFAs in a descriptive method.
After completion of the treatment period, a post-treatment safety visit will be conducted.