The agreement gives Argentis the rights to the treatment, as well as the processes involved in manufacturing the pharmaceutical product.
Systemic sclerosis (SSc or systemic scleroderma) is an autoimmune disease whereby the immune system attacks the body’s own type 1 collagen, causing fibrosis of the skin, lungs and other organs. As SSc progresses, patients suffer increasing difficulties with digestion, breathing, joint pain and often develop pulmonary hypertension.
The use of orally administered, highly purified native bovine type 1 collagen (CI) for the treatment of SSc was pioneered by Dr Arnold Postlethwaite, director of the division of connected tissue disease at the University of Tennessee Health Science Center.
According to Dr Postlethwaite: “One of the most widely distributed auto-antigens in SSc is type I collagen, the most abundant protein in the body and a component of all tissues, organs and blood vessels involved in the disease processes of SSc. Immune tolerance is induced by orally introducing type 1 collagen, meaning that the body’s immune system, over time, ceases to attack its own type 1 collagen.”
CI has completed a US National Institutes of Health-funded, 168-patient, double-blind, placebo controlled Phase II clinical trial with 13 rheumatology centers. The trial included patients with the diffuse form of SSc.
In addition to the placebo group, there were two prospectively defined subgroups in the Phase II trial: patients who had been diagnosed for less than three years (early phase) and those diagnosed from three to 10 years (late phase). Patients were treated for 12 months with follow-up at 15 months. Data from the trial demonstrated a statistically significant improvement in modified rodnan skin scores (MRSS), a measure of the change in skin thickening and an FDA-mandated endpoint, at 15 months in early phase patients receiving CI versus the placebo group. CI was also shown to be safe and well tolerated.
“With no therapies to treat the underlying cause of SSc, the prognosis for diagnosed patients is very poor,” stated Tom Davis, CEO of arGentis. Bringing the CI therapy to market will bring hope to tens of thousands of patients with the diffuse form of the disease. We anticipate a post-Phase II meeting with the FDA and EMEA in the next several months. These meetings should give us further clarity of the clinical path necessary for approval.”