Clinical Development

Approach

AB2 Bio has developed the first and proprietary assay to detect and measure free IL-18 in body fluids, which gives us the capability of identifying diseases associated with free IL-18 levels. The assay could also be used as a companion diagnostic to select patients most likely to respond to treatment with IL-18BP.

 

AB2 Bio is pioneering an empirical therapeutic approach to a rational selection of medical targets. If patients with high levels of free IL-18 can be identified, the clinical impact of treatment with IL-18BP will be maximized, while those patients unlikely to respond will not be unnecessarily exposed to ineffective medicines. Such an approach will reduce regulatory hurdles and increase the chances of successful clinical trials.

 

Extensive Phase I and Ib clinical trial results demonstrated that recombinant human IL-18BP is very well tolerated and has an excellent safety profile.
 

NLRC4 - MAS

Recently, single point mutations in the NLRC4 gene have been identified. These genetic and gain of function mutations give rise to severe, life threatening systemic inflammation as they are associated with extremely high levels of IL-18, the therapeutic target of AB2 Bio.

 

AB2 Bio is currently conducting a pivotal Phase III clinical trial.

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Adult onset Still's Disease

Adult onset Still’s Disease (AoSD) is a rare orphan inflammatory disorder typically associated with episodes of high spiking fevers, inflammatory synovitis, arthralgia and a general severe malaise. The clinical severity of AoSD is associated with laboratory markers of systemic inflammation, where high IL-18 levels are a dominant and constant feature during disease activity. There are currently no registered therapies for AoSD.

 

The Phase II clinical trial in Switzerland, France and Germany has been completed.

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Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is a chronic pulmonary disease that results in tissue remodeling and progressive lung destruction (emphysema). COPD is clinically characterized by non-reversible airway obstruction, shortness of breath and cough. Common comorbidities include heart failure. COPD is now a leading cause of mortality worldwide. Recent experimental and clinical investigations support the assumption that the inflammatory process is the main driver of the disease.

Dry Eye Disease

Dry Eye Disease (DED) is a multifactorial syndrome related to deficient tear production and can lead to damage of the eye surface integrity and loss of vision. Eye tissue inflammation is recognized as playing a key role in the development of dry eye pathology.

Other Indications

The combination of AB2 Bio’s assay and drug favors a personalized medicine approach to treat severe and life threatening diseases and build a strong pipeline with high chances of clinical success.

Using AB2 Bio’s proprietary assay, a thorough evaluation of other severe inflammatory diseases is ongoing to determine whether other diseases driven by high levels of free IL-18 can be identified. If positive, AB2 Bio will consider further clinical development.