About the RECONNOITER Study Program

(Randomized Evaluation of the benefit of Cilnidipine Only and in combination with tadalafil oN the Nature, Observational Indices, Temperature changes and overall Effect in scleroderma and Raynaud’s Disease)

The RECONNOITER Study is a 76 patient prospective, double-blind, randomized Phase 2A trial designed to assess the safety and efficacy of cilnidipine alone and in combination with tadalafil in patients with scleroderma and secondary Raynaud’s. The study will assess the impact of the treatments on a variety of endpoints including Raynaud symptoms, GI effects, endothelial dysfunction and overall assessments of well-being.

Patients will be recruited at two hospitals in Australia, and the study is expected to start in April 2021. Following this study, a United States multicenter study is planned.

Scleroderma, or systemic sclerosis, is a devastating autoimmune disease with the highest mortality and disability incidences of this group of diseases. While treatments have been approved to treat the lung changes that accompany the disease, there is no treatment approved to treat the Raynaud symptoms that occur in 95% of these patients, the GI symptoms, or significantly modify the course of the disease. It is hoped that the combination of these two drugs, called PROFERVIA®, may produce such as result.