Faron Pharma. Oy - Traumakine Update
("Faron" or the "Company")
- AGC Biologics selected as new commercial scale manufacturer
- COVID-19 trials continue to investigate Traumakine treatment
Commercial scale manufacturing
The Company has received a guarantee from
Faron also announces today that AGC Biologics, a leading global
"We are very happy to expand our partnership with Faron. Our priority has always been to serve our customers with a commitment to continuous innovation, aided by building strong, long term collaborative relationships," said AGC Biologics' CEO
Clinical investigations in COVID-19
Traumakine continues to be investigated as a potential COVID-19 treatment in global trials, including the
Traumakine is used in the trial's severe patients for whom it is critical to rapidly provide high serum concentrations of IFN beta-1a and to maximise levels of the drug in the lung vasculature where peripheral circulation is slowed1, a condition which can be life threatening for these virally-infected patients. Recent findings show that seriously ill COVID-19 patients have compromised interferon responses2.
In addition to the Solidarity trial, Faron continues to investigate Traumakine in two other clinical trials, the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, and the US HIBISCUS (Human Interferon Beta In Severe CoronavirUS) trial.
- The global REMAP-CAP trial is evaluating Traumakine as a potential treatment for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 14 countries.
- As previously announced, HIBISCUS will be an investigator-initiated study at
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").
1. 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
2. Impaired type I interferon activity and inflammatory responses in severe COVID-19 patients,
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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
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.
This information is provided by RNS, the news service of the
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