Biosergen AB announced an update of the Company's Phase 2 clinical trial development strategy. Based on the data from the completed Phase I trial, showing no severe side effects associated with BSG005, Biosergen will initiate a Phase 2 trial to show BSG005's potential to challenge Amphotericin B's role as a last resort antifungal treatment, as well as to de-risk the further development path of BSG005. Biosergen announce its plans to initiate its first Phase 2 clinical trial towards the end of Second Quarter 2023.

The multi-indication, open-label, single-center trial will be conducted at a site in India and enrol 15 patients suffering from invasive fungal infections, expected to include the infectious diseases the Company has previously highlighted as the main candidates for its Phase 2 programs; mucormycosis ("Black Fungus"), aspergillosis, and later febrile, neutropenic patients with symptoms of invasive fungal disease. The key enrolment criteria for the first phase 2 trial is, that the patients are, or have been, undergoing treatment with an Amphotericin B antifungal product but, due to intolerability or toxicity of Amphotericin B, have been taken off this last resort treatment, and are left without any effective treatment options. A top-line data readout is expected approximately six months after the dosing of the first patient, expected in early Third Quarter 2023.