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Ara3.5
ARA-290 – Forschung
Überwiegend Mechanismus / Beobachtung
13 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu ARA-290 sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus gemischt-qualitativen randomisierten Studien, veröffentlicht 2012–2025 mit einer typischen Studiengröße von 22 Teilnehmenden.
Basierend auf 13 Studien · 3 RCTs · 95 Teilnehmende insgesamt
Konfidenz
Mittlere Konfidenz
Nach Outcome
Pain & analgesia
Überwiegend Mechanismus / Beobachtung7 Studien
Nerve-fibre repair & neuroprotection
Überwiegend Mechanismus / Beobachtung6 Studien
Safety profile
Zu wenige bewertete Studien2 Studien
Stetige Forschung
2 Studien in den letzten 5 Jahren
201220182025
1Systematische Übersicht2025
Further controlled studies are required to establish safety, efficacy, and optimal therapeutic timing before translation to routine clinical use.
Sun Y, Song B, Zhang Y, Zhang Y, Zhou L. · Frontiers in neurology (2025)
Traumatic brain injury (TBI) unfolds through a well-defined chronology-hyperacute excitotoxic and inflammasome bursts, acute apoptotic and blood-brain-barrier failure, and subacute neurovascular remodeling-that no single-pathway drug can adequately cover.
We then match each derivative to its optimal injury window.
Meta-analyses of randomized trials suggest a possible trend toward lower short-term mortality without a consistent functional benefit or thrombotic signal.
Cibinetide significantly increased small nerve fiber abundance in the cornea and skin, consistent with a disease modifying effect.
Culver DA, Dahan A, Bajorunas D, Jeziorska M, van Velzen M, Aarts LPHJ, et al. · Invest Ophthalmol Vis Sci (2017)
Phase-2b, 28-day, multicenter randomized trial of 64 subjects with sarcoid-associated small-nerve-fibre loss and neuropathic pain
Doses of 1, 4 or 8 mg/day SC vs placebo; primary endpoint was change in corneal nerve-fibre area (CNFA) at day 28
Placebo-corrected CNFA increased significantly in the 4 mg group (697; 95% CI 159-1236; P = 0.012); intraepidermal regenerating GAP-43+ fibres also increased (P = 0.035)
Subjects receiving ARA 290 exhibited an improvement in hemoglobin A1c and lipid profiles... Neuropathic symptoms as assessed by the PainDetect questionnaire improved significantly in the ARA 290 group.
Brines M, Dunne AN, van Velzen M, Proto PL, Ostenson CG, Kirk RI, et al. · Mol Med (2015)
Phase-2 study in type-2 diabetes; ARA 290 4 mg/day SC self-administered for 28 days, followed for a further month
Improved HbA1c and lipid profile over the 56-day observation period; neuropathic symptoms (PainDetect) improved significantly vs placebo
Subjects with low baseline corneal nerve-fibre density showed a significant increase in CNFD vs no change on placebo
There was no improvement in mean change baseline-week 12 in BCVA, CRT, central retinal sensitivity or tear production... The cibinetide 12-week course was safe.
Lois N, Gardner E, McFarland M, Armstrong D, McNally C, Lavery NJ, et al. · J Clin Med (2020)
Open-label phase-2 trial; nine patients with diabetic macular edema self-administered cibinetide 4 mg/day SC for 12 weeks (eight completed)
Negative on primary visual endpoints — no improvement in best-corrected visual acuity or central retinal thickness
Improvement seen in NEI VFQ-25 quality-of-life composite and, in some participants, in CRT, tear production, diabetic control and albuminuria
In patients with sarcoidosis, ARA290 significantly improved neuropathic and autonomic symptoms, as well as quality of life... In both populations, ARA290 lacked significant adverse effects.
Dahan A, Brines M, Niesters M, Cerami A, van Velzen M. · Pain Rep (2016)
Narrative review of the innate-repair-receptor rationale and the ARA290 neuropathy program
Summarizes that ARA290 relieved mechanical/cold allodynia in mice but not in beta-common-receptor knockouts, supporting the IRR mechanism
Reviews human findings in sarcoidosis- and type-2-diabetes-associated small-fibre neuropathy, including 28-day corneal small-nerve-fibre regrowth
ARA 290 treatment was consistently associated with a significant improvement of neuropathic pain symptoms in sarcoidosis patients... Given the excellent safety profile while reducing neuropathy symptoms, the prospects of ARA 290 treatment in sarcoid neuropathy seem promising.
van Velzen M, Heij L, Niesters M, Cerami A, Dunne A, Dahan A. · Expert Opin Investig Drugs (2014)
Review of two phase-2 clinical trials of ARA 290 in painful small-fibre neuropathy (sarcoidosis and diabetes)
Reports decreased pain scores on validated questionnaires plus increased corneal nerve fibres and improved sensory thresholds and quality of life
Highlights ARA 290's tissue-protective, non-erythropoietic profile and favorable short-term safety
CNF area is a useful variable for quantifying change in CNF morphology... in patients with SFN following cibinetide administration, an agent which promotes nerve repair.
Brines M, Culver DA, Ferdousi M, Tannemaat MR, van Velzen M, Dahan A, et al. · Sci Rep (2018)
Methodology study on corneal confocal microscopy as a non-invasive readout of small-fibre-neuropathy severity and nerve repair
Pools diabetic-polyneuropathy and sarcoidosis-SFN patients, including those treated with cibinetide
Shows corneal-nerve-fibre area tracks neuropathy severity and treatment-associated change
ARA 290 could effectively suppress EAN by attenuating inflammation and exerting direct cell protection... haematopoiesis was not induced by ARA 290 during EAN treatment.
Liu Y, Luo B, Han F, Li X, Xiong J, Jiang M, et al. · PLoS One (2014)
Preclinical study in experimental autoimmune neuritis (a model of inflammatory peripheral demyelinating disease)
ARA 290 improved recovery, nerve regeneration and remyelination, and suppressed inflammation without inducing haematopoiesis
Shifted T-cell differentiation toward regulatory/Th2 phenotypes and promoted Schwann-cell proliferation
Cibinetide activation of the IRR exerts potent anti-inflammatory effects, especially within the myeloid population, reduces disease activity and mortality in mice.
Nairz M, Haschka D, Dichtl S, Sonnweber T, Schroll A, Asshoff M, et al. · Sci Rep (2017)
Preclinical DSS-induced colitis model in mice
Cibinetide (and EPO) improved weight gain and survival and preserved tissue integrity by reducing myeloid-cell infiltration and pro-inflammatory mediators
Anti-inflammatory effect depended on CD131 and JAK2 and was mediated via inhibition of NF-kB p65 — mechanistic support for the IRR pathway