Sareum Regulatory News (SAR)

Sareum Holdings PLC

("Sareum" or the "Company")

Completed Covid-19 Research Project Delivers Encouraging Results

Cambridge, UK, 1 July 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, is pleased to announce encouraging top-line results from its UKRI grant funded Covid-19 research project.

The aim of this research project was to investigate the effects of SDC-1801, the Company's proprietary TYK2/JAK1 inhibitor, on cytokine signalling after SARS-CoV-2 infection. It was also designed 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 by SDC-1801.

The project has completed on schedule, with the final results confirming the initial encouraging results as noted in the Company's Interim Results, published on 23 April 2021. The results of the project found that SDC-1801 reduced the levels of cytokines associated with Acute Respiratory Distress Syndrome (ARDS) in human lung cells infected with SARS-CoV-2 and demonstrated a profile that was superior to the anti-inflammatory steroid dexamethasone and similar to baricitinib, a JAK1/JAK2 inhibitor.

Subsequent completed in-vivo studies support the initial cellular results and indicate:

· Strong evidence that expression of Type 1 interferons (IFNa and IFNb) is reduced by SDC-1801 treatment in a dose-responsive manner; and that

· Viral loads did not increase after SDC-1801 administration, a potential concern when anti-inflammatory agents are used to dampen down an over-active immune response

A secondary objective, the investigation into whether treatment with SDC-1801 in disease models could protect against bacterial pneumonia following SARS-CoV-2 infection was inconclusive, due to technical shortcomings in the disease model.

Subject to successful completion of the ongoing preclinical toxicology studies, requisite approvals and financing, the Company aims to commence Phase 1 clinical trials for SDC-1801 in early 2022. The timing and design of the clinical trials for Covid-19 applications will be determined following consultations with experts in the field.

Dr John Reader, CSO of Sareum, commented:

"The results from our Covid-19 research project are very encouraging and provide clear evidence of the potential of SDC-1801 to reduce the excessive inflammatory response seen in severe Covid-19. We are keen to progress this project to the next stage and will now explore our options to find the best way to fund these next steps. This could include the UK government's AGILE clinical development platform, which was established to fund Phase 1 trials and fast-track the development of potentially ground-breaking Covid-19 treatments. These activities are expected to run in parallel with the broader SDC-1801 development plan targeting autoimmune diseases. We look forward to providing updates on our progress as we reach key milestones in the development of SDC-1801."

The Grant for the project was awarded to Sareum through the Innovate UK Sustainable Innovation Fund for projects that address and mitigate the health, social, cultural and environmental impacts of the Covid-19 outbreak.

The information contained within this announcement is deemed by the Company to constitute inside information under the Market Abuse Regulation (EU) No. 596/2014

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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 

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