TURKU - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces that the U.S. Food and Drug Administration (FDA) has approved the Phase II/III HIBISCUS trial assessing Traumakine, Faron's intravenous (IV) IFN beta-1a, for the treatment of hospitalised patients with COVID-19.

In the study Traumakine will be used prior to the current practice of corticosteroids, to prevent systemic inflammatory response syndrome (SIRS) and acute respiratory distress syndrome (ARDS), to improve clinical condition and reduce patient death. The study sponsorship has now been changed to Faron, with Professor Daniel Talmor from Harvard University's Beth Israel Deaconess Medical Center, as the Principal Investigator.

The mode of action of Traumakine is, in addition to a profound antiviral effect, to upregulate the cell surface protein, Cluster of Differentiation 73 (CD73). SIRS may be caused by both infectious assaults such as COVID-19, influenza and other micro-organisms, as well as noninfectious insults, such as trauma, ischemia-reperfusion injury or burns. SIRS is characterised by early excessive inflammatory cytokine production, initiated by extracellular ATP, a potent mediator of inflammation and thrombosis, which can also lead to vascular dysfunction, capillary leak and thrombosis, ultimately leading to life-threatening multiple organ dysfunction syndrome (MODS).

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Sandy Jamieson

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About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company's pipeline candidate to prevent vascular leakage and organ failures is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland.

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as 'believe', 'could', 'should', 'expect', 'hope', 'seek', 'envisage', 'estimate', 'intend', 'may', 'plan', 'potentially', 'will' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

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