Assessing the Safety and Efficacy of ARA 290 in Sarcoidosis Patients with Symptoms of Small Fiber Neuropathy

Assessing the Safety and Efficacy of ARA 290 in Sarcoidosis Patients with Symptoms of Small Fiber Neuropathy

Sarcoidosis is a condition characterized by the presence of tiny clusters of inflammatory cells in various parts of the body.  Although most commonly observed in the lungs or lymph nodes, sarcoidosis can also affect other organs in the body, including the eyes, skin, and heart[1].

One of the most common clinical manifestations associated with sarcoidosis is a dysfunction of small nerve fibers that occurs in a patchy, non-length-dependent manner, a condition more commonly known as small fiber neuropathy (SFN). Symptoms of SFN include pins-and-needles, tingling, and numbness; in severe cases, SFN symptoms can include short sensations of shock-like or burning pain, allodynia, and loss of cutaneous sensation and autonomic function.

With the specific cause of sarcoidosis still unknown, and considering recent research demonstrating the prevalence of SFN being grossly underestimated and with no known cure for the condition, Heij et al. developed this randomized double-blind pilot study to examine the safety and efficacy of ARA 290 in sarcoidosis patients with symptoms of SFN.

ARA 290 is a peptide that interacts with the innate repair receptor responsible for initiating cytoprotection, anti-inflammation, and healing. Considering that ARA 290 has been shown to reduce allodynia when tested in preclinical neuropathy models, Heij et. al. hypothesized that patients experiencing symptomatic SFN would benefit from treatment with ARA 290.

To test their hypothesis, the authors of this study enrolled 22 patients diagnosed with sarcoidosis and experiencing symptoms of SFN in either a group receiving intravenous dosing of ARA 290 or a placebo three times a week over the course of a four-week period.

At the conclusion of their study, Heij et al. observed that patients tolerated repeated intravenous infusions of ARA 290 without adverse events. The authors also observed a time-dependent, significant difference between ARA 290 and placebo groups. Specifically, ARA 290 appeared to improve autonomic and pain symptoms associated with SFN, including the severity of dry eyes, blurred vision, and muscle cramps and the severity and frequency of chest pain as assessed by the small fiber neuropathy screening list (SFNSL).

The authors concluded that their study was the first study to demonstrate that ARA 290 appears to be safe when administered repeatedly over a four-week period to sarcoidosis patients with symptoms of SFN with no abnormalities or drug-related adverse effects noted during and after dosing. ARA 290 also appeared to improve the severity and frequency of symptoms associated with SFN while also improving the quality of life and pain for these patients.

Heij et al. indicated that the primary limitations of this trial were the small sample size, patient variability of neuropathic involvement, and lack of skin biopsy or sudomotor testing evidence definitively establishing SFN. The study also demonstrated abnormalities in mechanoreception that prevented the observed reduction in the severity of symptoms as assessed by the SFNL from being fully attributed solely to the effects of ARA 290 on small-fiber function.


The observed reduction of SFN-associated symptoms combined with the acceptable safety demonstrated by frequent administrations of ARA 290 encourages a larger study to examine the potential effects of ARA 290 for sarcoidosis patients with symptoms of small fiber neuropathy.

Source:   (2019, January 30). Sarcoidosis – Symptoms and causes – Mayo Clinic. Retrieved from https://www.mayoclinic.org/diseases-conditions/sarcoidosis/symptoms-causes/syc-20350358


[1] “Sarcoidosis – Symptoms and causes – Mayo Clinic.” 30 Jan. 2019, https://www.mayoclinic.org/diseases-conditions/sarcoidosis/symptoms-causes/syc-20350358. 19 Aug. 2021.

Targeting The Innate Repair Receptor To Treat Neuropathy Using ARA 290 Peptide

Targeting The Innate Repair Receptor To Treat Neuropathy Using ARA 290 Peptide

While medical knowledge and understanding of the pathophysiology associated with neuropathic pain have increased dramatically over the last 10 years, the medical community is still finding it difficult to control the chronic pain associated with this condition.

Characterized by a wide range of clinical symptoms, including spontaneous pain, allodynia, and hyperalgesia, patients experiencing neuropathic pain and discomfort are also much more likely to experience anxiety, depression, sleep disturbances, and social isolation. 

While there are several therapeutic treatment options, including pharmacotherapy, interventional therapies, physiotherapy, and cognitive intervention, less than half of those experiencing neuropathy-associated pain experience adequate pain relief after these treatments. The result is a continuous reduction in quality of life often characterized by severe side effects associated with current pharmacotherapies.

Considering that an important and common feature associated with neuropathic pain is the occurrence of peripheral and/or central inflammation thought to be caused by nerve damage, Dahan et al.’s study examined the role of the innate repair receptor in the treatment of neuropathy.

The innate repair receptor (IRR) consists of the erythropoietin receptor and the β-common (CD131) receptor and is believed to activate anti-inflammatory and tissue repair pathways in response to peripheral nerve injury. Specifically, the IRR appears to be increased in response to injury and as a way to control and/or reduce the typical neurogenic inflammatory response by isolating and destroying the toxins, pathogens, and damaged tissue associated with the injury. 

One specific IRR agonist, a small peptide known as ARA 290, appeared to significantly improve symptoms of neuropathy and quality of life in patients with sarcoidosis and with type 2 diabetes (T2D); patients with T2D also showed improved metabolic profile. Treatment with ARA290 for 28 consecutive days demonstrated small nerve fiber regrowth in the cornea, but not in the epidermis. 

The authors found that ARA 290 treatment was well tolerated by patients with sarcoidosis and with T2D and produced no significant adverse effects.

Dahan et al. concluded that treatment with IRR offers the potential to reduce tissue damage while also supporting healing and repair occurring as a result of a number of disease processes.  Specifically, the peptide ARA 290 has demonstrated the potential to reprogram an area of inflammation and tissue damage into one of healing, growth, and repair.

The authors also point out that while there appears to be potential in the use of IRR for treating neuropathy, clinical observations have been limited to 28 days. As such, the authors also call for longer clinical trials with extended follow-up as a way to assess the full healing potential of IRR activation as disease-modifying therapy.

Source:   (n.d.). Targeting the innate repair receptor to treat neuropathy: PAIN Reports. Retrieved from https://journals.lww.com/painrpts/fulltext/2016/08000/targeting_the_innate_repair_receptor_to_treat.2.aspx

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