Biosergen

Invasive fungal infections represent a serious health threat, claiming 2.5 mill lives annually. There is growing resistance toward current therapy and the lack of broad-spectrum safe therapies has the WHO on high alert. It needs attention, and we need novel effective safe treatments. Biosergen is developing BSG005 designed to be safe, efficacious and broad-spectrum.

We have been focusing on the starting our first patient trial in India. As communicated previously, the regulatory approvals were received as scheduled in February/March, but the import license for the medication was pending for approximately three months. We followed up on the matter with the appropriate Indian Government office daily, and finally got the permission to import the medication by end of June. Following the approval, we were able to import BSG005 into India and began recruitment with the first patient enrolled in the trial in July. 

The first patient was indeed a treatment success both in terms of efficacy and safety. The patient was a 47-year-old male patient with uncontrolled diabetes presented with fever, cough, and haemoptysis. He underwent bronchoscopy-guided lung tissue biopsy which was positive for Mucormycosis (black fungus). He entered the study based of Mucormycosis with moderate renal impairment. The patient was dosed with the study drug (BSG005), and dose escalation of 0.1mg/kg was done at every three days once, when patient completed the treatment on day 28 he received a daily dose of 1mg/kg. Patient recovered well and is on observation. His renal parameters also improved to normal. It is a very remarkable case. Mucormycosis is one of the most difficult fungal strains to treat and he recovered. His renal parameters normalised as well as his electrolytes. He had no major safety issues during treatment even at very high doses. Also, it should be noted that Mucormycosis patients normally undergo surgery to remove the infected tissue to avoid further spreading. In this  case, due to the location of the fungus, it meant removal of one of his lungs. The investigator decided to continue treatment and thanks to his recovery, the patient preserved both his lungs. A second patient has just started treatment, and the initial dose went fine.

“It is indeed a major milestone to have had our first patient treated with 005 and we are pleased with the favorable outcomes. We look forward continuing to treat patients in need of urgent care.” Says Tine Olesen

Currently five sites are involved in the trial and all sites are ready to enroll patients. The investigators are highly motivated and very skilled in infectious disease management and emergency care. Recently, we held our first face-to-face investigator meeting in Mumbai, India, where the key focus of our discussions at this stage of the trial was recruitment. Recruitment is challenging since eligibility criteria mandate participants to be unsuitable for standard of care either by failing prior therapy, having mild/moderately impaired kidney function, or do not tolerate current treatment. The first sites opened are primarily in private hospitals where the approval process of the ethics committee (“EC”) is faster. The second wave of sites to open will be governmental sites, with a slower process to get EC-approval but access to far more patients. We expect to get all EC-approvals of the remaining sites during September through November. In total we plan to include up to 15 patients and the goal with the study is to increase survival rates for very ill patients with difficult to treat fungal strains and/or with resistance to current antifungal treatment.

Our estimate of the timeline for the last patient last visit is end of January 2025. We had a slower than anticipated start of the trial but our partner, Alkem Laboratories Ltd, has been very active and taken responsibility of the process. It is satisfying to witness their engagement and commitment. Alkem Laboratories Ltd, a leader in the anti-infective market and one of India’s top 5 pharmaceutical companies, will finance the patient costs in the upcoming phase 2 and phase 3 trials in India. Alkem holds commercial rights for India while Biosergen keeps commercial rights elsewhere.

We continue to follow up with sites and recruit patients. We plan to report highlights from our patients on an ongoing basis. More news to come in the next months.