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ARA-290 History: Study Type Comparison
Phase I Safety (2007) Healthy volunteers (n=32) Safety and pharmacokinetics No dose-limiting toxicity; t½ ~4–6 hours Single-dose administration; short observation period Established safety profile for subsequent efficacy trials Phase II Sarcoidosis SFN (2014)
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- Phase I Safety (2007)
- Healthy volunteers (n=32)
- Safety and pharmacokinetics
- No dose-limiting toxicity; t½ ~4–6 hours
- Single-dose administration; short observation period
- Established safety profile for subsequent efficacy trials
- Phase II Sarcoidosis SFN (2014)
- Sarcoidosis patients with SFN (n=39)
- Change in IENFD at distal leg
- +0.9 fibers/mm vs placebo (p=0.03)
- Small sample size; 28-day duration may underestimate long-term effect
- Proof-of-concept for nerve fiber regeneration in human subjects
- Phase II Diabetic Neuropathy (2015)
- Type 2 diabetes with painful neuropathy (n=84)
- Neuropathic pain score reduction
- Significant benefit only in confirmed SFN subgroup
- Heterogeneous patient population; pain scores subjective
- Suggests biomarker-driven patient selection improves response rate
- Preclinical AKI Model (2013)
- Rodent ischemia-reperfusion injury
- GFR preservation and tubular necrosis score
- 30–40% reduction in necrosis; GFR maintained vs control
- Rodent model may not predict human AKI response
- Mechanistic validation for cytoprotection; human translation pending