Sareum Notes New UK Government Covid-19 Initiative

SAREUM HOLDINGS PLC

("Sareum" or the "Company")

Sareum Notes the Launch of the UK Government's AGILE Platform to Fund and Fast-track the Early Clinical Development of Potential Covid-19 Treatments

Cambridge, UK, 16 February 2021 - Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, notes the announcement from the UK Government Department of Health and Social Care on 13 February 2021, regarding the launch of its AGILE clinical development platform to fund Phase 1 trials and fast-track the development of potentially ground-breaking Covid-19 treatments.

The Company views this new platform as a welcome source of funding to support the early clinical development of promising new candidates to address the breadth of symptoms that affect patients with Covid-19. 

As previously announced, Sareum is currently investigating SDC-1801, its selective, small molecule TYK2/JAK1 kinase inhibitor, in a preclinical Covid-19 research programme. The programme, which commenced in December 2020 with grant funding from the UK government, is expected to take approximately six months to complete and aims to investigate the effects of SDC-1801 on cytokine signalling after human cells are infected with SARS-CoV-2, to confirm whether an over-active inflammatory response (known as a 'cytokine storm') via the Interferon Type 1 pathway can be blocked in this disease. The Company is also investigating whether treatment with SDC-1801 in disease models can re-establish protection against bacterial pneumonia following SARS-CoV-2 infection.

The Company has previously stated it would require additional funding to advance SDC-1801 into clinical trials depending both on positive results from its ongoing Covid-19 research programme and on the successful outcome of the Company's broader preclinical development programme with SDC-1801. The Company believes that, should the current preclinical work programme be successful and indicate that SDC-1801 is a potential treatment for severe-phase Covid-19, the Company may be eligible for an AGILE grant.

Sareum's CSO, Dr John Reader, commented:

"We are delighted that the UK government has created the AGILE clinical trial platform and has provided the funding needed to support this exciting and much needed initiative, which may represent a potential route of future funding for the Company. Despite the successful UK vaccination programme, we believe that there is still a clear need for new therapies to treat severe respiratory inflammation arising from viral infections such as Covid-19. Should the Company's current work programme be successful, we will consider this new initiative as a potential source of funding contributing towards advancing SDC-1801 as a potential treatment for Covid-19 patients."

The Company notes that at the recent launch of the AGILE clinical trial platform, Health and Social Care Secretary, Matt Hancock, said:

"Today's news will ensure all phases of clinical trials for new treatments are done in the UK, protecting our supply chain and securing the world's best treatments for NHS patients at a much faster rate. I am immensely proud of the work that's been undertaken by the brilliant scientists behind these treatments and the thousands of UK patients who have taken part in the trials. Together, we can continue to ensure the UK is one of the best countries in the world for trialling and deploying the most ground-breaking medical advancements for both COVID-19 and for dangerous diseases in the future."

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About the AGILE Clinical Trial Platform

On 13 February 2021, the Department of Health and Social Care announced a new initiative under which the UK government is providing millions of pounds of additional funding to expand the new AGILE clinical trial platform. The funding has been awarded by the Medical Research Council (MRC) and co-funded though the National Institute for Health Research (NIHR).

This new platform will allow for global innovators to progress cutting-edge treatments for COVID-19 through all 3 clinical trial phases in the UK, further protecting our supply chain. This in turn will attract the brightest of researchers and manufacturers from around the world to trial their medicines here in Britain.

AGILE is a UK phase 1 and 2a clinical trial platform designed for rapid clinical evaluation of potential COVID-19 treatments. It is a collaboration between the University of Liverpool, the University of Southampton Research Unit, and other external partners.

The innovative design of the trial means that multiple potential treatments can be evaluated in parallel and important testing stages can be completed in months rather than years, while maintaining a high level of safety at all times

Patients in early stages of COVID-19 infection will be recruited to AGILE from the community, in addition to patients who have been hospitalised with COVID-19.

Treatments that show a signal of benefit in AGILE will be rapidly considered for advancement into later phase clinical trial platforms, such as PRINCIPLE and RECOVERY, where the effectiveness of treatments can be proven in greater patient numbers.

The Therapeutics Taskforce will work with innovators to support them to progress their promising treatments through clinical trial phases.

Future treatments to enter AGILE will be selected by the UK COVID-19 Therapeutics Advisory Panel (UK-CTAP), who lead the process of reviewing and evaluating proposals for treatments to enter UK national trial platforms.

About Sareum

Sareum is a specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases. The Company aims to generate value through licensing its candidates to international pharmaceutical and biotechnology companies at the preclinical or early clinical trials stage.

Sareum is advancing internal programmes focused on distinct dual tyrosine kinase 2 (TYK2) / Janus kinase 1 (JAK1) inhibitors through preclinical development as therapies for autoimmune diseases, including the 'cytokine storm' immune system overreaction to Covid-19 and other viral infections, (SDC-1801) and cancer immunotherapy (SDC-1802).

Sareum also has an economic interest in SRA737, a clinical-stage oral, selective Checkpoint kinase 1 (Chk1) inhibitor that targets cancer cell replication and DNA damage repair mechanisms. Preliminary Phase 2 and comprehensive preclinical data suggest SRA737 may have broad application in combination with other oncology and immune-oncology drugs in genetically defined patients.

SRA737 was discovered and initially developed by scientists at The Institute of Cancer Research in collaboration with Sareum, and with funding from Sareum and Cancer Research UK. SRA737 was licensed by CRT Pioneer Fund (CPF) to Sierra Oncology Inc. Sierra continues to explore options that would enable the development of SRA737 to advance.

Sareum Holdings plc is listed on the AIM market of the London Stock Exchange, trading under the ticker SAR. For further information, please visit the Company's website at www.sareum.com