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

December 12, 2022: Biosergen AB (“Biosergen” or the “Company”) today announced that the first volunteer in the MAD part of the Phase I study has been dosed with the Company’s proprietary antifungal drug candidate 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.

For further information about Biosergen, please contact:
Dr. Peder M. Andersen, CEO
Telephone: +45 2080 2470
E-mail: peder.andersen@biosergen.net

or

Niels Laursen, CFO
Telephone: +45 4014 5059
E-mail: niels.laursen@biosergen.net

Certified Adviser
Erik Penser Bank
Telefon: +46 8 463 8000
E-mail: certifiedadvisor@penser.se

ABOUT BIOSERGEN

Biosergen is a No-Research-Development-Only biotechnology company that employs all its organisational and financials resources on the clinical development of BSG005. BSG005 is a potentially disruptive antifungal drug with blockbuster potential based on significant safety and potency advantages over competing antifungals, including Amphotericin B, in more than a decade of preclinical studies. The research behind BSG005 and its unique properties has been documented in over 20 peer reviewed scientific papers. Biosergen initially aims BSG005 towards invasive fungal infections that claim the lives of hundreds of thousands of immune-compromised AIDS-, cancer- and transplant patients every year. At equal dose levels BSG005 shows a three-to-fourfold potency advantage against relevant fungal strains compared to current standards of care, while being completely free of the kidney toxicity hampering other drugs in its class. The Company is also developing BSG005 Nano where the drug is packed in special nano particles to specifically target the lung, often the first affected organ in an invasive fungal infection. BSG005 Nano Oral is an extension of BSG005 Nano. An oral formulation would greatly increase the usefulness, particularly as a prophylactic and as home treatment after transplants or cancer treatment to prevent invasive fungal infection. Biosergen has received orphan drug status for BSG005 in the United States and EU.