According to a recent article, Revolo Biotherapeutics announced it has obtained approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for two Phase 2 clinical trials to analyze its ‘1805 immune-resetting drug candidate to treat rheumatoid arthritis and posterior uveitis or panuveitis.

Rheumatoid Arthritis (RA)

Simply put, RA is a chronic inflammatory disorder affecting many joints, including those in the hands and feet. The course of RA is hard to predict. It usually progresses slowly over months or years, but in some people, RA doesn’t get worse, and symptoms plateau. In rare cases, symptoms come on rapidly, within mere days. Symptoms can come and go. RA patients may have periods of remission when joint pain goes away on its own for a while. However, if the disease progresses, joint pain can restrict simple movements, such as your ability to grip, and daily activities, such as climbing stairs. It is a common cause of permanent disability. However, early treatment may control the disease and keep it from getting worse. There are more than 200,000 new cases of RA in the U.S. per year. RA has a worldwide distribution with an estimated prevalence of 1 to 2%. Prevalence increases with age, approaching 5% in females over age 55. Both incidence and prevalence of RA are two to three times greater in females than in males.

Symptoms:

RA requires a medical diagnosis. It affects joint linings, causing painful swelling. Over long periods, the inflammation associated with RA can cause bone erosion and joint deformity. People may experience:

• Pain areas in the joints, back, or muscles
• Stiffness, swelling, tenderness, or weakness in joints
• Fatigue, anemia, or malaise in the whole body
• Lumps or redness in the skin
• Bumps or swelling on the fingers
• Flares, dry mouth, physical deformity, or sensation of pins and needles

Panuveitis

Panuveitis is an inflammation throughout the eye, particularly throughout the uvea. The uvea is the middle part of the eye, between the white part of the eye (sclera) in the front and the retina and optic nerve in the back. Within the uvea, there’s the iris, the ciliary body (muscles that work with the lens), and the choroid (connective tissue and blood vessels in the middle of the eye). However, inflammation in the uvea can spread throughout other parts of the eye, including the retina, optic nerve, vitreous fluid, and lens, especially if the condition is left untreated.

Symptoms:

Sometimes, panuveitis shows up suddenly and acutely; other times it slowly builds or hums along in a low-key chronic stage. A visit to an ophthalmologist is necessary to get an accurate diagnosis. Some common symptoms are:

• Blurring vision
• Light sensitivity (photophobia)
• Eye pain and redness
• Decreased vision
• Floaters in the vision
• White-colored area on part of the iris (hypopyon)

Uveitis

Uveitis is a term that refers to inflammation of a part of the eye called the uvea. The uvea is the middle layer of the eye; it protects the eyeball and provides most of the blood supply to the retina. There are multiple types of uveitis, as detailed below. Uveitis is often connected with other diseases or conditions. It can occur in all ages, but primarily affects people between 20 and 60 years of age.

The type of uveitis depends on the part of the eye that is inflamed. It can affect one or both eyes.

• Iritis, or anterior uveitis: Affects the front of the eye. The most common type of uveitis.
• Cyclitis, or intermediate uveitis: Affects the ciliary body, the area just between the iris and the choroid.
• Choroiditis, or posterior uveitis: Affects the retina and/or the optic nerve and may lead to permanent vision loss. The most uncommon form of uveitis.
• Pan-uveitis: Affects all three major parts of the eye.

Symptoms:

Symptoms often come on suddenly and can worsen rapidly. They include, but are not limited to:

• Eye redness
• Eye pain
• Sensitivity to light
• Blurry vision
• Dark spots in one’s field of vision, or “floaters”
• Vision loss

It is recommended to contact an ophthalmologist as soon as possible after symptoms arise.

‘1805

Revolo Biotherapeutics is a company that develops therapies that reset the immune system in order to get long-term remission for patients with autoimmune and allergic diseases. Its immune-resetting drug, ‘1805, is set to undergo two phase 2 clinical trials to test its efficacy in treating rheumatoid arthritis and posterior uveitis or panuveitis in the UK.

‘1805 works by resetting the immune system upstream of the inflammatory cascade instead of after inflammation has happened.

The Phase 2 Trials

The first Phase 2 trial will look into ‘1805’s use for RA. The trial will be randomized, double-blind (neither the patient nor the doctor will know if the patient received the treatment or the placebo), and placebo-controlled. This is going to be a dose-escalation study, and it will specifically look at the effects of the medications use in moderate to severe RA.

The study is hoping to get 92 patients to participate. It will last for 24 weeks, and those weeks will be split into a 12-week treatment period and a 12-week follow-up period. The treatment will be administered by IV bolus and will be tested at doses of 15 mg, 50 mg, and 100 mg.

The other Phase 2 trial will look at ‘1805’s efficacy in treating noninfectious, active, intermediate, or posterior uveitis or panuveitis. It will be a prospective, open-label (information is not withheld from patient), dose-escalation study. Researchers are aiming to have 25 patients in the trial. The endpoint of the trial will be the clinical response taken at week 12. Similar to the other trial, the treatment will be administered by IV bolus at doses of 15 mg, 50 mg, and 100 mg.