Pressreleaser | 12 Dec 2022 | Biosergen

Biosergen AB: The first volunteer has been dosed in the MAD part of the Phase I trial of BSG005

Biosergen has enrolled the first subjects into the MAD part of the Phase I trial of BSG005. The subjects will be part of a first cohort of total six healthy volunteers. The successful completion of the first MAD cohort part and the Phase I trial will be a major milestone for Biosergen, as it will underline the safety of BSG005.  From the SAD part we know, that BSG005 has shown no kidney or liver toxicity. From the in vitro (fungal cells) and in vivo (mouse model) testings, it is known that BSG005 has broad anti-fungal and fungicidal (killing fungals) effect on a broad range of fungal strains – including resistant and difficult to treat fungal strains. Kidney toxicity has been and still is a limiting factor, which made Amphotericine B/Ambisome a highly needed, but nevertheless last resort in systemic antifungal therapy.  Polyene antifungals where BSG005 and Ambisome belong is the only class of product with a proven fungicidal efficacy.  Therefore, showing safety and no kidney or liver toxicity in the healthy volunteers of the BSG005 infusions is one of the key events in the successful development of BSG005. It may allow for BSG005 to access the full commercial potential of a polyene antifungal product.

The Multiple Ascending Dose part of the trial may enroll up to 30 volunteers divided into possible 5 cohorts each of 6 subjects. The subjects in each cohort will receive 7 days of dosing and cohorts will receive increasing doses of BSG005. While the objectives of the Single Ascending Dose trial was to establish a basic understanding of BSG005’s safety and tolerability and also pharmacokinetics when given as a single dose, the Multiple  Ascending Dose (MAD) will be looking at safety and tolerability during 7 days of dosing and look at ”steady state” plasma concentrations. Biosergen expects to be able to publish data from this part of the trial in Q2/3 2023.

Biosergen’s CEO Peder M. Andersen comments:
We are very satisfied that we have reached the next important milestone in our Phase I development as the first volunteers has started dosing in the first MAD cohort. The next weeks will be exciting and we are of course eager to see how 7 days of dosing will affect the volunteers. The full cohort dosing is planned to be complete just before Christmas and the Safety Review Committee will review all data mid January and decide on the second cohrt dose.