Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

First Results from WHO Solidarity Trial

WHO concludes that subcutaneous IFN beta-1a is ineffective in hospitalized COVID-19 patients

Company announcement, 16 October 2020 at 1.35 PM (EEST)

TURKU, FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces that the first results from the World Health Organization's (WHO) Solidarity trial have been made available as a preprint at medRxiv1 while under review for publication in a medical journal. The results show that subcutaneous interferon (IFN) beta-1a was found to be safe, but ineffective to reduce overall mortality in hospitalized patients with COVID-19.

The WHO's intent-to-treat analysis compared 1412 patients who received IFN beta-1a and 2050 control subjects not receiving IFN beta-1a. The use of corticosteroids was 50% across the study. Overall in-hospital mortality (the primary endpoint) was 12.9% in the IFN beta-1a group and 11% in the control group, RR 1.16 (95% CI, 0.96 - 1.39, NS). The WHO reports that patients mainly received subcutaneous IFN beta-1a (Rebif, Merck KGaA). At the time of the data-cut for this analysis, Traumakine, the Company's intravenous (iv) formulation of IFN beta-1a, became available very late in the observation period and it is the Company's understanding it had seldom been used. The WHO has not been able to verify how many patients received Traumakine at the time of this analysis. About half of the patients receiving IFN beta-1a also received concomitant corticosteroids.

Dr. Markku Jalkanen, Faron's CEO, said: "These first results from the Solidarity Trial are disappointing, given the need for new therapeutics to support the global response to COVID-19. They do support our long held view that IFN beta-1a is likely to be ineffective when given subcutaneously. The science behind Traumakine and its potential to prevent multi-organ failure, through the upregulation of the key endothelial enzyme CD73, is compelling and we continue to believe that an intravenous formulation of IFN beta-1a is what patients need, to strengthen the body's own IFN beta signalling - the first line of defence against viral infection - and provide optimal exposure to the lung vasculature2.

"Compared to subcutaneous IFN beta-1a, the same amount of intravenous IFN beta-1a achieves over 150x higher peak concentration in the lung vasculature without higher systemic exposure3, which we believe makes this method of administration highly effective and safe. We will continue to pursue the science behind this."

Traumakine continues to be investigated in the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, which is evaluating potential treatments for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 19 countries.

Faron is also supporting a US trial to investigate the potential of Traumakine to treat COVID-19. HIBISCUS (Human Interferon Beta In Severe CoronavirUS), an investigator initiated study at Harvard Medical School's Beth Israel Deaconess Medical Center (BIDMC), focused on ICU patients with ARDS caused by viral infection (e.g. COVID-19, influenza). Commencement of this Phase II/III pivotal, randomized, placebo-controlled study, remains subject to finalisation of funding arrangements and regulatory approval. The study will test Traumakine against both placebo and dexamethasone, which is now a part of the standard of care in the US.

References

1. https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1 

2. Interferon beta-1a for COVID-19: critical importance of the administration route, Jalkanen et al., Critical Care (2020) 24:335 https://doi.org/10.1186/s13054-020-03048-5

3. Buchwalder et al. Pharmacokinetics and Pharmacodynamics of IFN-b1a in Healthy Volunteers. Journal of Interferon and Cytokine Research 2020; 20:857-866.

Notes to editors

Further information on the results of the Solidary trial is available at https://www.who.int/news/item/15-10-2020-solidarity-therapeutics-trial-produces-conclusive-evidence-on-the-effectiveness-of-repurposed-drugs-for-covid-19-in-record-time .

The preprint is available at https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Cairn Financial Advisers LLP, Nomad Sandy Jamieson, Jo Turner, Mark RogersPhone: +44 207 213 0880 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.com

About Faron Pharmaceuticals Oy

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. Further information is available at www.faron.com

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.