Biosergen

Biosergen's partner, Alkem Laboratories Limited ("Alkem"), has received an approval of the Clinical Trial Application and an import license from the Central Drugs Standard Control Organization (CDSCO) in India. The approval and import license allow for the initiation of the first patient trial for BSG005. A clinical trial designed to address unmet medical needs in invasive fungal infections. Biosergen and Alkem will enrol patients suffering from severe fungal infections, including mucormycosis (Black Fungus), aspergillosis, and candidiasis.

The trial focuses on patient populations intolerant or resistant to Amphotericin B, the current last-resort treatment for severe invasive fungal diseases, as well as those who have experienced treatment failure with first-line therapy. Finally, also patients with mild to moderate kidney impairment can be enrolled. These populations urgently require an alternative treatment option, as currently, no effective alternatives are available. The primary objective of this patient trial is to evaluate the potential of BSG005 as a rescue treatment based on the promising safety and efficacy profile demonstrated in preclinical studies of BSG005 and the results of the Phase 1 trial, which showed the absence of severe side effects.

The first approval came already in February 2024. The final permission needed was the import license. It has taken some time to receive the permission, but it is now granted and Alkem can now import BSG005 study drug to be used in the trial. Compared to earlier information from Biosergen the delay in granting the import license has delayed the start of the study. Tine Olesen, CEO of Biosergen commented on the delay and what Biosergen has done to risk mitigate the delay stating: `To make up for the time lost, the most impact full activity we have decided on is that we have doubled the number of hospitals to recruit patients, and we have further additional sites as back ups. We have Ethics Committee approval at all sites (including the back up sites) by now which is another step in the process. We prepare ourselves for a flying start.

The next steps in the trial preparation are to ship BSG005 to India get it labelled appropriately, ship it to the sites and then start recruiting the patients. BSG005 is for acute treatment, and it will be tested in intensive care units.