POS1244 results of a phase 2A study of cilnidipine, a novel daily oral calcium channel blocker with N-channel selectivity, for the treatment of raynaud’s and other symptoms in patients with systemic sclerosis
Abstract
Systemic Sclerosis(SSc) is a rare autoimmune disease with fibrosis, changes in the skin, vasculature, joints and internal organs. Diffuse disease involves lung, heart and kidney and 10-year mortality is >35%.[1]Raynaud’s attacks occur in ~95% of SSc patients. Severe Raynaud’s (RP) affects patients’ health status more than depression, obesity, and heart disease.[2]No treatment for Raynaud’s is approved, but calcium channel blockers (CCBs) are first-line treatment. Cilnidipine, a 4th generation CCB approved for hypertension in Asia, has been shown to be safer than other CCBs in treating hypertension, and has beneficial effects on the kidney and heart. Cilnidipine is more selective for N-type Ca channels, and improves analgesia, sympathetic, autonomic and endothelial function.[3]Cilnidipine might be repurposed for SSc-RP patients.We studied safety and preliminary efficacy of cilnidipine use in SSc-RP, dose response and co-administration of a low dose PDE-V inhibitor. Results are compared to a 2017 meta-analysis of CCB use in SSc-RP.RECONNOITER-1 is a two-part, planned 76 patient trial. In Part 1, we evaluated safety, dose, efficacy and co-administration of tadalafil. Dose groups were cilnidipine 10mg and 20mg, alone and with tadalafil 5mg, tadalafil alone and placebo. The 1° endpoint was reduction in weekly frequency of RP. 2° endpoints included Raynaud’s Condition Score (RCS), pain, severity, duration, and a validated PRO (SHAQ). The DSMB reviewed data on the first 27 patients…
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