22 June 2021 - - The US Food and Drug Administration has confirmed that US-based biopharmaceutical company Xentria Inc satisfactorily addressed all requirements and can proceed with initiation of the planned Phase 1 clinical trial of XTMAB-16, the company said.

The trial will be conducted at Parexel Baltimore Early Phase Clinical Unit, Medstar Harbor Hospital, Baltimore, MD.

Founded in April 2020, Xentria is an innovative biopharmaceutical company with the primary focus of building an expansive product pipeline of cost-effective and efficacious biologics to treat rare diseases, immunologic, metabolic diseases, musculoskeletal disorders, and certain types of cancer.

Sarcoidosis is a chronic, multisystem inflammatory disorder of unknown etiology that is characterized by the presence of noncaseating epithelioid granulomas, accompanied by infiltration of mononuclear cells and destruction of microarchitecture.

The disease can affect the skin, eyes, heart, and central nervous system, and >90% of cases involve the lungs. Symptoms range from asymptomatic to severe--including respiratory insufficiency, blindness, neurological disease, and cardiac death.

While medications for systemic organ involvement often control this disease, some patients fail to respond to initial treatments and require additional targeted therapy, resulting in significant costs and treatment burdens.

This disease presents a significant unmet medical need and a very important area of research and development for Xentria.

XTMAB-16 is a chimeric human-murine IgG1κ anti-TNFα monoclonal antibody with a molecular weight of ~149 kDa being developed as a novel biologic product for the treatment of patients with sarcoidosis with or without extrapulmonary involvement.

No TNF-α inhibitor is currently approved for the treatment of sarcoidosis. Extensive analyses have been conducted to demonstrate the physio-chemical properties and pharmacology of XTMAB-16 as a TNF-α inhibitor.

Xentria, whose name stems from the word "centrality" was founded in 2020 and is an innovative biopharmaceutics company whose primary focus is to build an expansive product pipeline of cost-effective and efficacious biologics to address critical unmet need for patients suffering from rare diseases, immunologic, metabolic, and musculoskeletal disorders, as well as oncology.

Headquartered in Chicago, with partners in Israel and China, the company is dedicated to research and development, clinical science, manufacturing, and commercialization and driven to treat the clinical and social burdens of diseases while fostering sustainable growth.