AURORA Trial of CIVI030 for Raynaud’s Due to Scleroderma Resumes Patient Enrollment

A Phase 3 trial testing iloprost, known as CIVI030, for the treatment of Raynaud’s phenomenon due to scleroderma has resumed patient enrollment, according to the therapy’s developer, CiVi Biopharma.

The trial (NCT04040322), named AURORA and sponsored by Civi’s subsidiary Eicos Sciences, launched in October 2019 but was forced to a temporary halt last March due to the COVID-19 pandemic.

AURORA is now once again recruiting adults experiencing Raynaud’s phenomenon associated with scleroderma, with a goal of enrolling about 180 participants. The study is taking place at 30 clinical sites across the U.S. More information on locations and contacts is found here and here.

CiVi expects to complete enrollment by April 2021, and to report top-line data soon after.

“We look forward to completing enrollment in this registrational study as there are currently no U.S. Food and Drug Administration (FDA) approved therapies to improve symptoms in patients with [scleroderma],” Shalom Jacobovitz, CEO of CiVi Biopharma, said in a press release.

“Completing this pivotal study will bring us one step closer to achieving our goal to develop the first FDA-approved treatment that can improve outcomes in patients experiencing this painful and debilitating condition,” Jacobovitz added.

Raynaud’s phenomenon in people with scleroderma is characterized by numb, prickly, and frigid fingers and toes, in response to cold temperatures or stress.

The condition “impacts quality-of-life and day-to-day functioning and may be the initial sign of long-term progressive complications due to inflammation and scarring of the vessels that supply blood to the digits [fingers and toes],” added Dinesh Khanna, MD, chief medical officer of Eicos and a professor of medicine at the University of Michigan.

Iloprost is a man-made version of prostacyclin, a hormone that causes blood vessels to widen, reducing resistance to blood flow. An inhaled formulation of iloprost, sold as Ventavis, is approved by the FDA for the treatment of pulmonary arterial hypertension (PAH). Of note, scleroderma and PAH are two separate diseases that often coexist, making treatment and disease management for patients more complicated.

The European League Against Rheumatism recommends iloprost for the treatment of Raynaud’s phenomenon in patients who are not responsive to common oral vasodilators, which are medications that open the blood vessels.

In the AURORA study, scleroderma patients with symptomatic Raynaud’s phenomenon will be randomly assigned to receive an intravenous (into-the-vein) formulation of either CIVI030 or a placebo, for six hours a day over five consecutive days. The infusion rate will increase gradually from 0.5 nanograms (ng)/kg/min up to 2 ng/kg/min.

The study’s main efficacy goal is to assess the weekly change in the frequency of symptomatic Raynaud’s phenomenon attacks after 21 days (three weeks).

Secondary goals include evaluating the severity and duration of the attacks, and the percentage of patients reaching a pre-determined response.

In a previous case report, iloprost delivered via an infusable portable pump was deemed efficient and safe for the treatment of Raynaud’s phenomenon and digital ulcers in people with scleroderma.

CIVI030 has been granted orphan drug designation by the FDA, which aims to encourage therapies for rare conditions by a series of incentives, including seven years of market exclusivity and exemption from regulatory fees.