Clinical Trials

CB 4332

Catalyst Biosciences has launched a quest to identify people who lack Complement Factor I (CFI)

The ConFIrm and ConFIdence studies

If you’re interested in participating in this study, please click below for additional information:

For physicians

For patients

CFI-deficiency is an ultra-rare disorder that affects the immune system. It frequently starts at a young age, affects both females and males, and usually involves other family members. People with this condition are prone to recurrent infections, including infections of the upper respiratory tract, ears, skin, and urinary tract, or also may present certain autoimmune diseases. Screening for CFI deficiency only requires providing a blood sample in which the presence or functionality of the CFI protein will be assessed.

The ConFIrm study – Screening study to identify patients with CFI deficiencies

Catalyst’s ConFIrm study will test for CFI in people who experience signs and symptoms of CFI deficiency. The study has a global footprint to be able to reach out to as many patients as possible and contribute to revealing undiagnosed disease. Screening for CFI deficiency only requires providing a blood sample, in which the presence and function of the CFI protein will be assessed.

The ConFIdence study – Natural history study to assess the clinical outcomes of patients with CFI deficiency

The study will follow and observe patients identified in the ConFIrm screening study to assess their clinical progression and better understand this varied disease.

Participating in either of these studies is voluntary, does not require taking any investigational medications, and will contribute to a better understanding of the disease and its consequences.

Factor I is probably the most relevant down-regulator in the complement system

This system is composed of a series of plasma proteins and plays a critical role in host defense and inflammation. CFI deficiency causes a permanent, uncontrolled activation of the alternative pathway resulting in increased turnover and consumption of other complement factors resulting in a dysfunctional complement system and affecting its beneficial biological functions .

Catalyst plans to develop a recombinant CFI protein (CB 4332) which eventually could be used to restore the missing CFI levels and rebalance complement function addressing the root cause of the disease. The current standard of care treatment in people with such conditions addresses the symptoms of the disease but not the root cause. It consists of preventative vaccinations, prophylactic antibiotics, immunoglobulins, immunomodulators, or immunosuppressors. Most of these therapies are not devoid of relevant adverse events.

  For physicians

If you are a physician and have a patient who experiences repetitive bacterial infections, or who has experienced meningitis, or who does not respond well to antibiotic treatment, you may want to test them for CFI deficiency. Similarly, CFI deficiency has also been associated with unexplained persistent chronic inflammation or with certain autoimmune diseases like vasculitis, Bickerstaff encephalitis, aseptic meningoencephalitis, or glomerulonephritis. If you have patients with any of these indications, you may want to test them for CFI deficiency.

For more information, please contact Catalyst Biosciences at

  For patients

If you are an individual experiencing frequent and recurring infections, like otitis, tonsillitis, skin infections, lung infections, urinary or kidney infections or have been hospitalized for severe infections like meningitis or sepsis, and/or have relatives with similar conditions, you may want to discuss with your physician about being tested for CFI deficiency.

For more information, please contact Catalyst Biosciences at