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FDA grants fast track status for Araim’s ARA290 to treat Sarcoidosis-associated SFN

The US Food and Drug Administration (FDA) has granted fast track designation for Araim Pharmaceuticals' lead compound ARA290, to treat Sarcoidosis-associated Small Fiber Neuropathy (SFN).

The company said that ARA 290 activates the natural repair system of the body by activating the Innate Repair Receptor and thereby turning off systemic inflammation and turning on repair.

Sarcoidosis is an orphan disease and is diagnosed by the presence of granulomas in the lung, in adults aged between 20 and 40 years.

Currently, there are no approved treatments for Sarcoidosis-associated SFN.

The company has already completed exploratory trial and Phase IIa trials and is currently carrying out a Phase IIb dosing trial at Cleveland Clinic and Leiden Medical Center in the Netherlands.

Cleveland Clinic lead investigator Dr Daniel Culver said: "Typically, the effect of small fiber neuropathy on the quality of life of affected patients is very severe.

"The fast track designation of ARA 290 offers new hope for patients suffering debilitating pain and severe dysautonomia, who frequently are forced to stop working and may even be confined to a wheelchair."

Araim CEO Anthony Cerami said: "ARA 290 is a novel first in class drug that has the potential to be the next generation of anti-cytokine therapies — it turns off all damaging cytokines we have tested, and in animal and preliminary human trials promotes the repair of small nerve fibers- demonstrating real disease modification."