News & press

Istesso commences Phase 2a for MBS2320 in rheumatoid arthritis and expands R&D collaboration with Janssen

Istesso Ltd (‘’Istesso’’) is pleased to announce the successful dosing of the first patients in a Phase 2a study of its investigational drug, MBS2320, for the treatment of rheumatoid arthritis (“RA”). The progression to Phase 2a follows the successful completion of dosing in a Phase 1 study and is accompanied by an expansion of the financial terms of Istesso’s 2014 Option and Licence Agreement with Janssen Biotech, Inc. (“Janssen”).

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.

The progression to Phase 2a follows the analysis of data emerging from a Phase 1 trial in which MBS2320 has demonstrated good safety and tolerability in healthy volunteers, as well as predictable blood exposure levels (“pharmacokinetics”). Analysis of the data from a cohort of RA patients included in the trial is ongoing, with good safety and tolerability observed to date.

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 autoimmune 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 act by reprogramming metabolism to treat autoimmune and inflammatory conditions such as rheumatoid arthritis and multiple sclerosis. Istesso was founded in 2017 as the holding company for Modern Biosciences plc. For more information please visit www.istesso.co.uk.

Modern Biosciences announces collaboration with Johnson & Johnson Innovation and Janssen for novel oral therapies for rheumatoid arthritis

Modern Biosciences plc (‘’MBS’’) is pleased to announce that it has entered into an R&D alliance and global option and licence agreement with Janssen Biotech, Inc. (“Janssen”) in relation to MBS’ novel bone-protective compounds for the treatment of rheumatoid arthritis (“RA”). The goal of the collaboration, facilitated by the Johnson & Johnson Innovation Centre in London, is to develop new drugs for the treatment of RA.

Under the terms of the exclusive agreement, MBS will receive an up-front payment and is eligible to receive development, regulatory and commercialisation milestone payments up to a potential total of £176 million. In addition, MBS will receive royalties on future sales of any products that may result from the alliance upon successful launch and commercialisation.

RA is a severe, painful inflammatory disease that can cause progressive joint and bone erosion and eventually lead to disability. MBS’ compounds work by a novel mechanism of action that targets both the inflammatory component of RA and the associated bone destruction. This approach has the potential to not only protect the joints of people living with RA from further damage but to control the pain and swelling associated with the disease. The most advanced of MBS’ compounds is in pre-clinical development and is due to enter Phase 1 clinical studies in 2015.

Sam Williams, CEO of MBS, said: “We are delighted to be working with Janssen to progress our novel series of compounds. MBS’ compounds have unique characteristics compared to existing treatments for rheumatoid arthritis and we believe Janssen is an ideal partner with which to take the molecules forward. This agreement demonstrates MBS’ business model, which is to take early-stage assets from academia and advance them to a point of value inflexion when they can be licensed to industry, generating a return for our stakeholders.”

For further information, please contact: Dr Sam Williams, CEO 0845 074 2929

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 an incredibly painful condition, can cause severe disability and ultimately affects a person’s ability to carry out everyday tasks. The disease can progress very rapidly, causing swelling and damage to cartilage and bone around the joints. Any joint may be affected but it is commonly the hands, feet and wrists that are involved. It is a systemic disease which means that it can affect the whole body and internal organs such as the lungs, heart and eyes.

About MBS’ bone-protective compounds

MBS’ novel bone-protection programme was licensed in 2007 from OsteoRX Limited (“OsteoRX”), a spin-out company from the University of Aberdeen (“Aberdeen”). The programme comprises a series of orally available small molecules which are highly effective in preventing rheumatoid arthritis in disease models. The compounds act via a novel molecular mechanism which means they not only reduce inflammation and bone damage associated with rheumatoid arthritis, but have the potential to reverse bone damage via a directly protective effect that is unique amongst existing agents. Under the terms of its agreement with OsteoRX and Aberdeen, MBS will share an undisclosed percentage of revenue generated under the Janssen agreement with Aberdeen and other stakeholders. MBS’ novel bone-protection programme was recently the subject of a £2.4 million award from Innovate UK through the BioMedical Catalyst (“BMC”). The BMC funding will make an important contribution to the Phase 1 programme and builds upon an earlier £1.6 million BMC award made in 2012 which enabled the programme to progress to its current stage.

About Modern Biosciences

Modern Biosciences is a drug development company which sources late-stage discovery projects from academia, conducts early proof-of-principle clinical studies and out-licenses the resulting programmes to the pharmaceutical industry. MBS’ major shareholder is IP Group plc, the developer of intellectual property based businesses. For more information, please visit www.modernbiosciences.com.

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