Aristea is developing novel therapies for autoimmune and inflammatory diseases with significant unmet medical needs.
RIST4721, our lead therapeutic candidate, is an orally administered molecule that inhibits the activity of CXCR2. CXCR2 is a prominent cytokine receptor with an important role in the recruitment of neutrophils to the site of inflammation.
Neutrophils are a type of white blood cell essential for maintaining innate immune surveillance under normal conditions, but during autoimmune and inflammatory processes, they are also a major contributor to tissue damage. Since CXCR2 plays a critical role in the regulation of neutrophil levels in affected tissues, CXCR2 inhibition with RIST4721 represents a promising therapeutic target for the treatment of a wide range of neutrophil-mediated autoimmune and chronic inflammatory conditions.
Palmoplantar pustulosis (PPP) is a rare chronic inflammatory skin condition characterized by the repeated appearance of sterile pustules filled with neutrophils on the palms of the hands and soles of the feet. Patients with PPP suffer from inflammation and cracking of the skin, causing pain, bleeding, itching and burning. This disease makes the performance of daily tasks extremely difficult. Patients with PPP have dramatic challenges to their quality of life. There are no approved therapies in the United States or Europe and those suffering from PPP have limited therapeutic options. PPP affects ~170K patients in the United States and is most common among women ages 40-69, as well as patients with a history of smoking tobacco.
In early 2020, we completed a Phase 2a clinical trial for our lead drug candidate, RIST4721, in PPP. We observed good activity particularly in patients who were actively flaring and whose disease was getting worse as they entered the clinical trial. We are now conducting a Phase 2b dose-ranging study.
In addition to PPP, we are planning additional Phase 2 studies of RIST4721 in other neutrophil-mediated inflammatory indications with a high unmet medical need.
FAMILIAL MEDITERRANEAN FEVER
FMF is a rare genetic autoinflammatory disease caused by variants of the MEFV gene, characterized by recurrent fevers and painful inflammation of the abdomen, chest, and joints.
It is particularly prevalent in certain Mediterranean populations, including people of Armenian, Turkish, Arabic, and North African Jewish descent, and affects about 1 in 200 individuals in these groups. Current treatment of FMF aims to prevent acute flares and minimize inflammation between flares in order to prevent the progression of amyloidosis.
Behcet’s disease is a multisystem inflammatory disorder that causes blood vessel inflammation (vasculitis). The most common disease manifestations include ulcers affecting the mouth and genitals, various skin lesions, and abnormalities affecting the eyes. Additional systems of the body may also be affected including joints, blood vessels, the central nervous system, and the digestive tract.
Despite currently available treatments for oral Behcet’s disease, physicians that treat Behcet’s disease still identify a significant unmet medical need that needs to be addressed with the development of new therapies.
Hidradenitis suppurativa (HS) is a chronic and progressive dermatological condition caused by inflammation of the sweat glands that causes nodules, abscesses, and scarring on the skin and is characterized by significant pain. The disease usually affects skin folds where the skin rubs together, including the armpits, groin, buttocks, and breasts, and it can be a serious impediment to daily quality of life.
The disease is estimated to affect between 0.03% and 4% of the population. Antibiotics, steroids, retinoids, and immunosuppressive biologics are used to control symptoms with limited success, but no cure for HS exists.
ONGOING AND UPCOMING CLINICAL TRIALS
At Aristea, we are committed to bringing new medicines to patients through a focused, diligent, and agile approach that keeps patients’ quality of life as a priority.
This is a randomized, double-blind, placebo-controlled, Phase 2b, 12 week, dose-ranging study of RIST4721 in subjects with moderate to severe palmoplantar pustulosis currently recruiting patients within North America and Europe (clinicaltrials.gov NCT05194839).
This is an open-label, single-arm, Phase 2a study to evaluate the safety and efficacy of RIST4721 in subjects with familial Mediterranean fever. Check back for more information.
This is a randomized, double-blind, placebo-controlled, Phase 2a study to evaluate the efficacy and safety of RIST4721 in subjects with hidradenitis suppurativa. Check back for more information.
This is a randomized, double-blinded, placebo-controlled, Phase 2a study to evaluate the efficacy and safety of RIST4721 in subjects with Behcet’s disease. Check back for more information.