Board Recommends Accelerating Trial of Profervia for Raynaud’s

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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An independent committee of experts recommended accelerating a Phase 2 clinical trial of Aisa Pharma‘s experimental oral therapy Profervia in scleroderma patients who have Raynaud’s phenomenon, a common disease where the fingers and toes become numb or tingly in response to cold or stress.

“We believe Profervia has the potential to produce clinically meaningful benefit in a safe and well tolerated oral daily treatment, which we hope will dramatically improve the lives of thousands of patients with scleroderma who currently have no approved options to treat their debilitating Raynaud symptoms,” Andrew Sternlicht, MD, Aisa’s founder and CEO, said in a press release.

Profervia contains a reformulated form of cilnidipine, a calcium channel blocker that is currently approved in certain Asian countries as a treatment for high blood pressure. According to Aisa, the therapy works to increase blood flow to peripheral organs and tissues, and it also may have pain-relieving effects. The company also says that cilnidipine has shown better tolerability than other medications in its class in clinical trials.

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Aisa is currently running a Phase 2 study called RECONNOITER to evaluate Profervia in scleroderma patients with Raynaud’s. The study consists of two parts: the first part is evaluating different doses of the experimental therapy. The second part aims to test one dose against a placebo in a double-blind randomized crossover — meaning patients will initially either be given Profervia or a placebo, and then will switch.

Like other clinical trials, RECONNOITER has a data safety monitoring board (DSMB) — a group of external experts who review unblinded data from the trial while it is ongoing. The DSMB is tasked with ensuring the safety of trial participants, as well as the scientific rigor of the study.

Here, the DSMB reviewed data from the first 27 patients in the dose-finding portion of the RECONNOITER study and concluded that there were no safety issues of concern.

The DSMB also “remarked that the treatment appeared to be much better tolerated than their own and published clinical trial experience of currently used calcium channel blocker therapy for treating Raynaud’s in Scleroderma patients,” according to Aisa.

Based on these findings, the DSMB has recommended accelerating the RECONNOITER trial. The study will now proceed directly into the second part, omitting an additional nine patients who had been planned for the dose-finding portion.

“We are excited with this first DSMB review of the RECONNOITER data,” Sternlicht said.

Sternlicht added that Aisa is planning to apply to the U.S. Food and Drug Administration (FDA) seeking permission to begin clinical testing of Profervia in the U.S. and also will ask the FDA to give the experimental therapy orphan drug status. These activities are expected to be completed by early next year.