Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Traumakine update

- New trial protocol preventing concomitant corticosteroid use with Traumakine

- Company notes WHO recommendations on use of steroids in coronavirus patients

Company announcement, 06 February 2020 at 9.00 AM (EET)Inside information

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on Traumakine's clinical continuation following a meeting with the U.S. Food and Drug Administration (FDA) in December 2019.

Following feedback from the FDA regarding the design of the next Traumakine study and receipt of agreed meeting minutes, Faron has updated the proposed study design and has submitted the amended trial protocol to the FDA. The trial protocol has been amended to reflect the FDA's feedback that further studies with interferon-beta (IFN-beta) should exclude the use of overlapping steroids since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient outcomes. Faron will continue to work in close collaboration with the FDA to achieve final approval for the next study.

The Company notes with interest a recent recommendation by the World Health Organization (WHO) that steroids should not be used on coronavirus infected patients1. One of the main first lines of defence against viral infection is endogenous IFN-beta production2. Blocking endogenous IFN-beta production using steroids may be deleterious to treatment outcomes in these patients. Therefore, exogenous IFN-beta (like Traumakine) can strengthen further this endogenous IFN-beta action and provide maximal protection against viral infections but it has to be administered without concomitant corticosteroids, which have the capacity to disturb or block IFN-beta action.

A recent descriptive study published in The Lancet3 on the 2019 novel coronavirus (2019-nCoV) outbreak in Wuhan, China reports that 17% of the 99 patients with 2019-nCoV pneumonia developed Acute Respiratory Distress Syndrome ("ARDS") and 11% worsened in a short period of time and died of multiple organ failure. 19% of patients in the study received corticosteroids, a treatment option no longer recommended by the WHO.

Dr. Markku Jalkanen, Faron's CEO, said: "With no currently approved pharmacological treatments available, ARDS remains a significant problem for patients and healthcare systems. We are pleased to note that the WHO has recognised the risk of using corticosteroids on patients with coronavirus, which aligns with our findings from post-hoc analysis of the INTEREST study.

"One of the main first lines of defence against viral infection is endogenous interferon-beta production. Faron believes Traumakine treatment, in the absence of concomitant corticosteroid use, can further strengthen this endogenous IFN-beta action and provide increased protection against serious lung complications arising from viral infections. Faron remains committed to developing Traumakine for the potentially fatal condition ARDS."

References

1. Clinical management of severe acute respiratory infection when novel coronavirus (nCoV) infection is suspected; WHO interim guidance, 28 January 2020 https://www.who.int/publications-detail/clinical-management-of-severe-acute-respiratory-infection-when-novel-coronavirus-(ncov)-infection-is-suspected 

2. Global virus outbreaks: Interferons as 1st responders; Seminars in Immunology 43 (2019) 101300 https://doi.org/10.1016/j.smim.2019.101300 

3. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study; The Lancet, published online 29 January 2020 https://doi.org/10.1016/S0140-6736(20)30211-7 

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

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

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, its 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, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. 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.