In short
MIB2, also known as StaphAcute, is an investigational protein-based substance being studied for the treatment of Staphylococcus aureus bacteremia (SAB), a serious bloodstream infection. A combined Phase 1/2 clinical trial is currently authorised to evaluate its safety and tolerability in healthy volunteers and in patients with SAB. The trial plans to enroll 54 participants and includes both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) infections.
Key points
- MIB2 (StaphAcute) is an investigational substance being tested against Staphylococcus aureus bacteremia, including MRSA.
- The authorised trial is a combined Phase 1/2 study with a planned enrollment of 54 participants.
- Phase I involves healthy volunteers in a first-in-human dose escalation study.
- Phase IIa includes patients with MSSA or MRSA bacteremia receiving standard-of-care antibacterial therapy.
- The primary outcomes focus on safety and tolerability, including adverse events and determining the maximum tolerated dose.
- MIB2 is given as a single intravenous infusion in the trial.
What is MIB2?
MIB2, also referred to as StaphAcute, is an investigational protein-based substance. It has not yet received marketing authorisation as a medicine in the records available. The substance is currently being evaluated in a first-in-human clinical trial to determine whether it can be safely given to people.
How does MIB2 work?
The exact mechanism of action of MIB2 is not described in the available trial registry data. The ongoing trial is designed to investigate the safety and pharmacokinetics of the substance, which means researchers will study how the drug is absorbed, distributed, and eliminated from the body.
Which conditions is it studied for?
- Staphylococcus aureus bacteremia (SAB): a bloodstream infection caused by the bacterium Staphylococcus aureus. The Phase IIa part of the trial includes patients with either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) forms of this infection.
- Healthy participants: the Phase I part of the trial is a first-in-human study involving healthy volunteers for dose escalation.
How is MIB2 given?
In the clinical trial, MIB2 is administered as a single intravenous infusion. The trial also includes a comparison arm receiving sodium chloride (a saline solution) by intravenous infusion.
What do the clinical trials show?
One clinical trial is currently authorised for MIB2. It is a combined Phase 1/2 study with a planned enrollment of 54 participants.
What are the phases and status?
The trial is authorised and interventional. Phase I is a first-in-human, dose escalation study in healthy participants. Phase IIa includes patients with MSSA or MRSA bacteremia who are receiving standard-of-care antibacterial therapy.
What is measured?
The primary outcomes in both phases are the occurrence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) after a single intravenous infusion of MIB2. In Phase I, researchers also aim to determine the maximum tolerated dose (MTD) up to 20 mg per kilogram of body weight.
Who can take part?
Phase I enrolls healthy volunteers. Phase IIa enrolls patients with confirmed Staphylococcus aureus bacteremia, including both methicillin-susceptible and methicillin-resistant infections, who are undergoing standard-of-care antibacterial therapy.
What side effects are known?
The safety profile of MIB2 is not yet known. The ongoing trial is specifically designed to evaluate adverse events and tolerability, which will provide the first information about potential side effects in humans.