Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Global Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) to study the effect of interferon beta-1a in COVID-19

Company announcement, 1 April 2020 at 9.00 AM (EEST)Inside information

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that regulatory approval has been granted for the global Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) program that includes intravenous (IV) interferon (IFN) beta-1a as a new treatment arm.

REMAP-CAP is a global network of leading experts, institutions and research networks with over fifty sites participating worldwide. The program recruits patients with community-acquired pneumonia, including COVID-19 patients, who require ICU care for the support of organ functions and uses an innovative trial design to efficiently evaluate multiple interventions simultaneously.

The study has several existing treatment domains including antibiotic and hydrocortisone treatment arms. Now, in collaboration with Faron, a new immune-modulatory treatment arm has been established to include intravenous (IV) IFN beta-1a. The study will, therefore, compare directly the treatment effect of Faron's investigational IV IFN beta-1a, hydrocortisone treatments, and other study treatment options on the clinical outcomes of COVID-19 patients and those with other causes of pneumonia requiring ICU care.

The study plans to include a total of 6,800 patients from study sites across Asia-Pacific, Europe and North America excluding US. Faron expects to contribute to the REMAP-CAP program by providing investigational IV IFN beta-1a (also known as Traumakine) to all sites and support also the communication between sites. In this regard, Faron is currently in the process of finalising an agreement for the study. This global study is supported by several funding agencies all over the world.

Dr. Markku Jalkanen, Faron's CEO, said: "We are extremely pleased for this opportunity to join this global initiative investigating the potential of multiple therapies to prevent COVID-19 and other community-acquired pneumonia patients from dying of acute respiratory distress syndrome (ARDS). The design of the REMAP-CAP trial will enable study subjects to be initiated onto investigational IV IFN beta-1a treatment relatively rapidly, on submission to intensive care, and before the development of ARDS. Many of these patients have a severe viral infection and so are an optimal target cohort for the Traumakine-project and the investigation of its potential.

"As this trial also has a hydrocortisone arm, it will provide a direct efficacy comparison between IFN beta-1a and hydrocortisone, and will provide further prospective data on the concomitant use of these treatments, following previous observations that the use of overlapping corticosteroids are likely to have a deleterious effect on IFN beta-1a.

"We continue to believe in the potential of the Traumakine-project as a future treatment for ARDS. This potential therapy uses an intravenous formulation of IFN-beta which we believe offers the administration route critically ill patients require for optimal exposure to the lung vasculature and treatment of ARDS."

"With the REMAP-CAP study and the announcement earlier this week that, subject to funding, we can move forwards with significant expansion of the Phase I/II Matins trial for Faron's novel macrophage checkpoint immunotherapy for untreatable solid tumours, we believe Faron is in an exciting position. The Directors continue to explore all funding options to capitalize on the opportunities ahead of us."

Detailed information of the REMAP-CAP trial can be found at ClinicalTrials.gov Identifier: NCT02735707 and information about REMAP-CAP at https://www.remapcap.org.

The trial protocol (Covid-19 Immune Modulation Therapy) details can also be here: https://www.remapcap.org/protocol-documents 

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

Notes to editors

REMAP-CAP clinical end points:

Primary Outcome Measures :

· All-cause mortality [ Time Frame: Day 90 ]

Secondary Outcome Measures :

· ICU Mortality [ Time Frame: Day 90 ]

· ICU length of stay [ Time Frame: Day 90 ]

· Hospital length of stay [ Time Frame: Day 90 ]

· Ventilator free days [ Time Frame: Day 28 ]

· Organ failure free days [ Time Frame: Day 28 ]

· All-cause mortality [ Time Frame: 6 months ]

· Quality of life assessment [ Time Frame: 6 months ]

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

Carnegie Investment Bank AB, Financial Adviser

Mika Karikoski (Investment banking)

Phone: +358 9 6187 1295

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.