BFB759

Table of contents

• What is BFB759?
• How does BFB759 work?
• Which conditions is BFB759 being studied for?
• How is BFB759 given?
• What do the clinical trials show?
• What side effects are known?

What is BFB759?

BFB759 is an investigational protein-based substance developed by Bluefin Biomedicine, Inc. It is classified as a protein of the type "Protein - Other" in the registry records, meaning it is not a small chemical molecule but a larger biological molecule.^[1] The substance has no marketing authorisation in the product records, which means it is not yet approved as a medicine for any condition.^[1] BFB759 is being investigated in the therapeutic area of skin and connective tissue diseases as well as immune system diseases.^[1]

How does BFB759 work?

The registry records do not describe the specific molecular target or mechanism of action of BFB759. It is registered as a protein-based substance, which means it is a biological molecule designed to interact with specific targets in the body, but the exact way it works has not been stated in the available trial records.^[1]

Which conditions is BFB759 being studied for?

• Atopic dermatitis — a chronic inflammatory skin condition that causes itchy, red, and dry skin. The trial evaluates BFB759 in adult participants with this condition.^[1]
• Hidradenitis suppurativa — a chronic skin condition characterised by painful lumps under the skin, including abscesses and inflammatory nodules. The trial studies BFB759 in adults with moderate to severe forms of this condition.^[2]

How is BFB759 given?

BFB759 is given as a subcutaneous injection, which means it is injected under the skin.^[1] The pharmaceutical form is recorded as an injection in the registry.^[1] The dose used in the trials is not reported in the registry records, as the intervention is listed as "00 mg", indicating the dose was not stated.^[1]

What do the clinical trials show?

BFB759 is being investigated in two clinical trials, both authorised and both in Phase 2. In total, these trials plan to enrol 429 participants.^[1][2]

What are the trials measuring?

The atopic dermatitis trial measures the percent change from baseline at Week 16 in the Eczema Area and Severity Index (EASI) score. EASI is a tool used by doctors to assess the extent and severity of eczema.^[1] The hidradenitis suppurativa trial measures the percent change from baseline at Week 16 in the count of abscesses and inflammatory nodules (AN).^[2]

Who can take part in these trials?

Both trials enrol adult male and female participants. The atopic dermatitis trial includes participants with atopic dermatitis, while the hidradenitis suppurativa trial includes participants with moderate to severe hidradenitis suppurativa.^[1][2]

What side effects are known?

No side effect information is available from the provided sources. The registry records do not include safety data for BFB759.