CiVi 030 is an intravenous formulation of iloprost, a potent vasodilator and platelet inhibitor with anti-inflammatory and anti-fibrotic effects being developed for the treatment of digital ischemic episodes in people with Systemic Sclerosis (SSc). CiVi 030 received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of SSc.
The AURORA study is a Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with SSc. Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT04040322. The AURORA study is being conducted by Eicos Sciences, a CiVi Biopharma, Inc. affiliated Company.
CiVi Biopharma expects to have the topline data from the AURORA study in 2021.
DIGITAL ISCHEMIC EPISODES (RAYNAUD’S PHENOMENON) IN SYSTEMIC SCLEROSIS
In 1862, Maurice Raynaud recognized that some people who were exposed to cold temperatures had transient digital ischemia (poor blood flow) as evidenced by demarcated pale or cyanotic skin limited to the digits. The term “Raynaud’s Phenomenon” is now used to describe these digital ischemic episodes.
Digital ischemic episodes (Raynaud’s Phenomenon) are characterized by color changes in the fingers (and often the toes) in response to cold exposure or emotion and are often associated with symptoms of pain, numbness, discomfort, and/or tingling in a majority of patients.
SSc results in digital ischemia due to progressive occlusive vasculopathy with compromised vessel lumen. In people with SSc, digital ischemic episodes (Raynaud’s Phenomenon) significantly 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. These slow progressive changes can cause more severe and longer lasting ischemic episodes, that can lead to digital ulcers, or sores, over the fingertips. If untreated, these superficial ulcerations can develop into deep-tissue necrosis with gangrene and ultimately result in amputations.
Digital ischemia in SSc represents a continuum that can progress from Raynaud’s Phenomenon to critical digital loss.
Raynaud’s Phenomenon: experienced by 95% SSc patients1
- SSc greatly exacerbates normal vasoconstrictive response to cold/stress
- Symptomatic attacks can be extremely painful and accompanied by numbness, tingling, and loss of dexterity
Digital Ulcers: experienced by >50% SSc patients1
- Necrotic lesions occurring at distal aspects of digits
- Can result in amputation, hospitalization, infection, gangrene
Gangrene in 10%, Infection in 26% over 2 years in patients with history of DUs2
Amputation in 16% over 2 years in patients with chronic DUs2
1Steen et al. Rheumatology 2009;48:iii19–iii24
2Matucci-Cerinic M, Krieg T, Guillevin, et al. Ann
Rheum Dis 2016; 75:1770-1776
There are currently no FDA approved therapies to treat digital ischemic episodes (Raynaud’s Phenomenon) associated with SSc. CiVi 030 has the opportunity to improve the quality of life and clinical outcomes for patients with SSc. For more information, please visit eicossciences.com
SSc Epidemiology and Treatments
This chronic disease affects approximately 75,000 people in the US, of which 80% are women, with typical onset of disease at 30-50 years of age. Treatment options for SSc are extremely limited, with no FDA approved therapies aside from those used for the management of associated Pulmonary Arterial Hypertension.
Of the US adult SSc population, approximately 40,000 (or 58%) present with moderate to severe digital ischemia, representing a significant unmet need and suffering.