The designation provides Araim with a seven year marketing exclusivity period against competition, and several incentives such as federal grants, tax credits and a waiver of PDUFA filing fees.
ARA 290 has earlier secured orphan drug designation in Europe for the treatment of sarcoidosis. It has also received US Orphan Drug and Fast Track designations to treat neuropathic pain in patients with sarcoidosis.
Preclinical data indicate a potential benefit of ARA 290 in treatment of small fiber neuropathy (SFN), as the drug showed efficacy in several animal models of neuropathy, neuroprotection, and neuro-inflammation.
ARA 290 is a synthetic 11-amino acid peptide IRR agonist. It is currently being assessed in the clinical developmental program for its ability to relieve symptoms related with sarcoidosis SFN and for the potential for disease modification and long-term functional enhancement in this condition.
The most advanced clinical program with ARA 290 is in sarcoidosis-associated small fiber neuropathy, with the recent completion of a phase 2b dose-ranging trial.
A pilot study assessing the safety and efficacy of ARA 290 in diabetic macular edema is currently ongoing at Queen’s University Belfast.
Last December, Araim partnered with Vault Bioventures to support development and commercialization of ARA 290 as well as other peptides within a novel family.