Revolo Biotherapeutics (Revolo Bio), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, announced that it has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to commence two phase 2 clinical trials to evaluate its immune-resetting drug candidate, ‘1805, in patients with autoimmune diseases, one in people with moderate to severe active rheumatoid arthritis (RA) and a second trial in people with noninfectious, active, intermediate, or posterior uveitis or panuveitis, in the United Kingdom. Revolo is also enrolling patients in two ongoing phase 2 studies to evaluate its drug ‘1104 in Eosinophilic Esophagitis (EoE) under a US IND in Allergic Disease.

“Given ‘1805’s mechanism of action that resets the immune system upstream of the inflammatory cascade, versus after inflammation has occurred, we believe this molecule has the potential to truly change the treatment landscape for multiple autoimmune diseases,” said Jonathan Rigby, chief executive officer of Revolo Bio. “We look forward to building on the promising clinical profile from our first phase 2a trial of ‘1805 in patients with RA and continue to show its clinical potential in other autoimmune diseases with high unmet needs, such as Uveitis, the leading cause of adult blindness in western countries. We plan to begin dosing of patients as soon as possible.”

Data from a previous phase 2a trial investigating ‘1805 in 24 patients with severe RA nonresponsive to standard of care demonstrated its potential as a safe and effective treatment, including rapid onset (week 3) and sustained remission (12 weeks) following a single intravenous (IV) dose.

Revolo Bio’s phase 2 trial in RA is a randomized, double-blind, placebo-controlled, dose-escalation study to investigate the effects of ‘1805 in patients with moderate to severe active RA. The study aims to enroll 92 patients and will last 24 weeks split into a 12-week treatment period and a 12-week follow-up period. ’1805’s efficacy in RA will be tested at doses of 15 mg, 50 mg, or 100 mg administered by IV bolus.

The second phase 2 study is a prospective, open-label, dose-escalation study to evaluate the safety and efficacy of ‘1805 in patients with Noninfectious, Active, Intermediate, or Posterior Uveitis or Panuveitis. The study aims to enroll 25 patients in a 16-week trial with the primary efficacy endpoint of clinical response measured at week 12. ’1805’s safety and efficacy in Uveitis will be tested at doses of 15 mg, 50 mg, or 100 mg administered by IV bolus.

‘1805 is a modified analogue of the endogenous immune-regulatory binding immunoglobulin protein (BiP), a key player in immune function that resets the immune system for long-term disease remission. Its mechanism of action creates vast optionality across multiple indications and routes of administration.

Revolo Biotherapeutics is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic disease, without the immune system suppression seen with current therapies.