Revolo Biotherapeutics has secured the approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to initiate two Phase II trials of its autoimmune disease drug candidate ‘1805.

The immune-resetting drug is an analogue of the endogenous immune-regulatory binding immunoglobulin protein (BiP).

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BiP plays a crucial role in immune function that readjusts the immune system for durable disease remission. 

One of the trials will enrol moderate-to-severe active rheumatoid arthritis (RA) patients while another Phase II trial will have individuals with non-infectious, active, intermediate, or posterior uveitis or panuveitis.

A randomised, placebo-controlled, double-blind, dose-escalation Phase II trial will analyse the impact of ‘1805 in 92 RA patients.

Set to have a treatment period as well as a follow-up period of 24 weeks, the trial will assess the efficacy of 15mg, 50mg, or 100mg intravenous (IV) doses of the drug.

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Another open-label, prospective, 16-week, dose-escalation Phase II trial will analyse the efficacy and safety of ‘1805 in non-infectious, active, intermediate, or posterior uveitis or panuveitis patients. 

It plans to have 25 subjects to analyse 15mg, 50mg, or 100mg IV doses of the drug.

Clinical response as assessed at week 12 will be the primary efficacy endpoint of this trial.

According to findings from a prior Phase IIa trial for severe RA, the drug was found to be potentially safe. 

It enrolled 24 individuals with severe RA who do not respond to standard of care therapy. 

Revolo Bio CEO Jonathan Rigby said: “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. 

“We look forward to building on the promising clinical profile from our first Phase IIa 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.”