Assessing a new treatment for invasive fungal infections

A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients With Invasive Fungal Infection

This study is testing a new intravenous treatment called BSG005 to see if it is safe and effective for people with uncomplicated invasive fungal infections.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Biosergen AS (Industry-sponsored)
• Locations: 1 site (Dehli, Haryana)
• Trial ID: NCT06678113 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI). It is an open-label, Phase 1b, dose-escalation study involving approximately 15 patients divided into three cohorts. Each patient will receive BSG005 via IV infusion once daily for three days, with potential dose adjustments based on safety and efficacy assessments. The study includes a screening period, treatment period, and follow-up period, with a total duration of up to 50 days for each participant.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with uncomplicated invasive fungal infections.

Not a fit: Patients with severe renal impairment or those who have not responded to first-line treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from invasive fungal infections.

How similar studies have performed: While this approach is novel, other studies have explored treatments for invasive fungal infections, but the specific efficacy of BSG005 remains to be established.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years.
2. Able to provide written informed consent or have a legally authorized representative that can provide informed consent in case of incapacitation.
3. Diagnosed by Investigator to have an IFI.

   \- Proven IFIs as defined in the 2020 consensus definitions by the European Organization for Research and Treatment of Cancer/ Mycoses Study Group Education and Research Consortium (EORTC/MSGERC). Probable or possible IFIs can be included using the EORTC/MSGERC criteria or other established criteria. The inclusion of patients with IFI caused by, eg, Aspergillus spp and Candida spp, is preferred as these species are generally known to be responsive to a lower dose than other species, eg, Mucor mycosis
4. IFI patients with mild to moderate renal impairment or IFI patients requiring an alternative treatment as current treatment cannot be continued due to any of the following

   1. Failure with one first-line agent, defined as either: Radiologic progression, Increase in serologic markers such as galactomannan antigen or beta-D-glucan, Failure of clearance of cultures , Progression or lack of improvement in a clinically appropriate timeframe of clinical symptoms attributed to IFI;
   2. Inability to tolerate AmB, as defined by at least one of the following: Nephrotoxicity with either: 1.5 mg/dL increase in creatinine from baseline, 50% increase in creatinine from baseline ii. Contraindication to use AmB with either:- Persistent hypokalemia or hypomagnesemia while on AmB despite appropriate electrolyte replacement
   3. Documented in vitro resistance to first-line antifungal therapy (ie fluconazole resistance in Candida auris)
   4. Treatment-limiting drug-drug interactions prohibiting the use of antifungals (azoles and echinocandins) such as concurrent rifampcin, rifabutin, phenytoin, carbamazepine, bedaqualine

Exclusion Criteria:

1. Patient has a known hypersensitivity or severe infusion-related reaction to any polyene drug.
2. Infection caused by a known or suspected organism with intrinsic resistance to AmB.
3. Concurrent use of another investigational agent within 30 days of enrollment.
4. Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 mL/min or dialysis. Patients with acute kidney injury with eGFR less than 30 mL/min and improving creatinine level can be included as judged by the Investigator.

   Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
5. Has liver enzyme results (aspartate aminotransferase \[AST\]/alanine aminotransferase \[ALT\]) greater than 5 times the upper limit of normal.

   Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
6. Has a bilirubin level greater than 5 times the upper limit of normal. Note: Patients may be rescreened within 48 hours if laboratory values are found to be abnormal.
7. Patients who have an ejection fraction less than 25% of predicted.
8. Currently pregnant or planning on getting pregnant while on study (details of contraception guidance are provided in Section 13).
9. Breastfeeding.
10. Patients not likely to survive a minimum of 28 days from start of screening.
11. Patient receiving prohibited medications.
12. Patient is an abuser of alcohol or medication.

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Where this trial is running

Dehli, Haryana

• JSS Medical Research Asia Pacific Private Limited — Dehli, Haryana, India (Recruiting)

Study contacts

• Study coordinator: Tine Olesen, CEO

Conditions Invasive Fungal Infection; Invasive fungal infection; BSG005; Polyene macrolide; Rescue therapy