Positive outcome from Phase 1 study of MBS2320

Positive outcome from Phase 1 study of MBS2320

Istesso announces positive outcome from patient cohort in Phase 1 study of MBS2320

Istesso Limited (‘‘Istesso’’) is pleased to announce new data from a cohort of patients dosed as part of a Phase 1 study of MBS2320, its investigational drug for the treatment of rheumatoid arthritis (“RA”). MBS2320 was safe and well-tolerated in these patients, and showed no interaction with background therapy. In addition, positive trends consistent with MBS2320’s mode of action were observed in biomarkers of inflammation and bone metabolism.

MBS2320 is a first-in-class metabolic reprogramming agent for the treatment of RA and is distinguished from existing RA treatments by its dual mode-of-action which directly targets both inflammation and bone degradation. As previously announced by Istesso, MBS2320 has already demonstrated good safety and tolerability and predictable pharmacokinetics in healthy volunteers as part of the Phase 1 study. A cohort of eight RA patients was included in the study to evaluate the pharmacokinetics of MBS2320 in patients taking methotrexate, a standard background RA therapy, and whether there is any interaction between the drugs. No interaction was observed.

In pre-clinical models of RA, MBS2320 has demonstrated an ability to reduce inflammation and promote remodelling of damaged bone. In the patient cohort, changes in biomarkers of inflammation, bone degradation and bone formation were observed that are consistent with this dual mode-of-action.

MBS2320 is currently being dosed as part of a Phase 2a study in RA, for which data is expected in late 2018. The Phase 2a study is a 12-week randomised, placebo-controlled, double-blind, multi-centre trial assessing the safety, tolerability and efficacy of MBS2320. Istesso anticipates that results will be available in late 2018.

For further information, please contact:

Istesso Limited

Dr Sam Williams, CEO +44 207 444 0066

Notes to Editors

About rheumatoid arthritis

Rheumatoid Arthritis (RA) is a chronic, progressive and disabling auto-immune disease affecting 165 million people worldwide, or one per cent of the global population. It is a painful condition that, unchecked, can cause severe disability. The disease can progress very rapidly, causing swelling and damaging cartilage and bone around the joints. Any joint may be affected but the hands, feet and wrists are most commonly involved, preventing patients from carrying out everyday tasks.

About MBS2320

MBS2320 is a first-in-class metabolic reprogramming agent for the treatment of RA and is distinguished from existing treatments by its dual mode-of-action which not only reduces inflammation, thereby preventing the progression of disease, but may also promote bone and joint remodelling. MBS2320 is subject to an Option and Licence Agreement with Janssen Biotech Inc.

About Istesso

Istesso is a drug discovery and development company working in the field of immunometabolism. Istesso’s pipeline of pre-clinical and clinical assets work by reprogramming metabolism to treat autoimmune and inflammatory conditions such as rheumatoid arthritis and multiple sclerosis. Istesso was founded in 2017 as the new holding company for Modern Biosciences plc. For more information please visit www.istesso.co.uk.

ENDS