Lara Heij, Marieke Niesters, Maarten Swartjes, Elske Hoitsma, Marjolein Drent, Ann Dunne, Jan C. Grutters, Oscar Vogels, Michael Brines, Anthony Cerami, Albert Dahan
ABSTRACT
ARA290, a peptide designed to activate the innate repair receptor that arrests injury and initiates cytoprotection, anti‐inflammation, and healing, reduces allodynia in preclinical neuropathy models. We studied the safety and efficacy of ARA 290 to reduce symptoms of small fiber neuropathy (SFN) in patients with sarcoidosis. Twenty two patients diagnosed with sarcoidosis and symptoms of SFN were enrolled in a double blind, placebo‐controlled exploratory trial of three times weekly intravenous dosing of ARA 290 (2 mg; n=12) or placebo (n=10) for 4 weeks. Inclusion criteria were a diagnosis of neuropathy and a spontaneous pain > 5 score (Brief Pain Inventory; BPI). Endpoints assessed were changes in pain intensity and the small fiber neuropathy screening list (SFNSL) score, quality of life (SF‐36), depressive symptoms (Inventory of Depressive Symptomatology; IDS), and fatigue (Fatigue Assessment Scale; FAS).
No safety concerns were raised by clinical or laboratory assessments. The ARA 290 group showed significant (p < 0.05) improvement at week 4 in the SFNSL score compared to placebo (Δ ‐11∙5 + 3∙04 versus Δ ‐2∙9 + 3∙34; SEM) . Additionally, the ARA 290 group showed a significant change from baseline in the pain and physical functioning dimensions of the SF‐36 (Δ ‐23∙4 + 5∙5 and Δ ‐14∙6 + 3∙9 respectively). The mean BPI and FAS scores improved significantly but equivalently in both patient groups. No change was observed in the IDS. ARA 290 appears to be safe in patients with sarcoidosis and to reduce neuropathic symptoms.