First Wave BioPharma has reached the enrolment target in the Phase II SPAN trial examining an improved enteric microgranule delivery formulation of adrulipase to treat exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients.

The ongoing, open-label, multi-centre trial aims to evaluate the safety, tolerability, and efficacy of the adrulipase formulation.

The primary efficacy endpoint of the trial is the coefficient of fat absorption (CFA).

The trial’s secondary endpoints are stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption (CNA).

To be carried out at three sites in the US, the trial has enrolled 13 patients aged 18 years or above.

During the trial, patients will be monitored at baseline to ensure that they have at least 80% of CFA.

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Eligible patients can then receive adrulipase in place of their respective commercial enzyme product.

Treatment of each of the patient will begin with a low dose of adrulipase. In case the patient is not clinically controlled, they will be transferred to a medium dose, and if not controlled on this dose, then they will be advanced to receive a high dose.

The titrations will be conducted for three weeks to get a CFA.

First Wave will compare the end-of-study CFAs to the baseline CFAs. A safety visit after the treatment will also be carried out one week after concluding the treatment.

First Wave BioPharma CEO James Sapirstein said: “The majority of patients in the study have completed dosing and the remaining patients are currently being dosed.

“We remain on track to report topline data in July 2023.”