FAST TRACK APPROVAL FOR SFN DRUG ARA290.

[Ema]

Here's hoping this drug will benefit some of us in the ME/CFS/SEID/PENIS community as well. Looks promising!

FAST TRACK APPROVAL FOR SFN DRUG ARA290
APRIL 16, 2015 JULES PRAST LEAVE A COMMENT
The trials with ARA 290, an experimental drug developed to treat sarcoidosis induced small fiber neuropathy, have continued into international phase 2c. What hurdles will have to be taken before it is available for patients? An interview with Chief Executive Officer of Araim Pharmaceuticals Inc., Dr. Anthony Cerami, who is developing the new first-in-class drug


Biochemist Dr Antony Cerami strongly believes in the potential of ARA 290. However, it will be quite some time before it is approved for use in sarcoidosis induced Small Fiber Neuropathy (SFN). ARA 290 is a unique compound that turns off inflammation and demonstrates the potential to reduce neuropathic pain and repair damaged small nerves. This may lead to a reduction of pain and an improvement of autonomic symptoms such as dry eyes, palpitations and dizziness. Moreover, the results of clinical trials give hope that ARA 290 can diminish the chronic fatigue many patients suffer from.

Click here for the full interview (pdf, 2.4MB)

Source: SarcoScoop, Quarterly Magazine of the Sarcoidosis Society of the Netherlands, December 2014 issue

 

[valentinelynx]

Journal article with more information:
ARA 290, a peptide derived from the tertiary structure of erythropoietin, produces long-term relief of neuropathic pain coupled with suppression of the spinal microglia response

http://www.molecularpain.com/content/10/1/13

Also, from PRNewswire (http://www.prnewswire.com/news-rele...ociated-small-fiber-neuropathy-280635872.html):

"ARA 290 has also received orphan status with the FDA and by the European Regulatory Agency. Phase 3 trials are slated to begin 4Q 2015."

 

[Marco]

What I found interesting is that they had trialled this drug on sarcoidosis patients who reported decreased severity of symptoms of small fibre neuropathy compared to placebo as measured by the disease specific SFNSL instrument.

But it wasn't the pain component of the scale that improved significantly but questions relating to autonomic function (including 'dry eyes', 'blurred vision' and 'dizzy when rising').

Safety and Efficacy of ARA 290 in Sarcoidosis Patients with Symptoms of Small Fiber Neuropathy: A Randomized, Double-Blind Pilot Study

The SFNSL assesses both the frequency and the severity of symptoms. As shown in Figure 4A, the frequency of SFN symptoms decreased moderately in both groups to a similar extent. In contrast, the severity of neuropathic symptoms remained constant in the placebo group over the dosing period, whereas it significantly improved in the ARA 290 group (Figure 4B). The SFNSL can also be separated into components that assess symptoms referable to autonomic dysfunction (questions 2–5, 9 and 11–16) or to pain (questions 1, 6–8, 10 and 17–21). Patients who received ARA 290 reported a significant improvement in their autonomic symptoms, in contrast to the placebo group (Figure 5). Although a similar improvement was noted for the pain dimension, the magnitude was not significantly different from that observed for the placebo group

http://static.smallworldlabs.com/molmedcommunity/content/pdfstore/12_332_Heij.pdf