Alzinova AB (publ) announced that based on strong clinical data, the company has received approval from regulatory authorities to evaluate a higher dose of the vaccine candidate ALZ-101 in the ongoing phase 1b study. The company considers this to be strategically important for the upcoming phase 2 study. The full analysis from the first part of the phase 1b study (part A) confirmed the favourable safety and tolerability profile observed in both dose groups.

In addition, a high frequency of immune response was demonstrated and furthermore that patients treated with ALZ-101 responded with antibody levels that increased with the number of doses given. The analysis also shows that patients dosed with the highest dose of the vaccine had a higher response rate compared with the lower dose. Based on the favourable results, Alzinova applied for an extension of the study to evaluate an additional higher dose, which has now been approved by the regulatory authorities.

The extension is made as an open-label part of the study and includes six patients who are treated with 400 ug over a 16-week period with four treatment sessions. The patients will then be followed up after another 4 weeks. Alzinova expects to be able to start recruitment for the extension in the spring of 2024 and this is not expected to affect the timetable for the planned phase 2 study.