Last checked at 19 Dec 2018 07:00
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Traumakine update
First YODA trial results confirm drug formulation not a factor in lowered bioactivity seen during INTEREST trial
TURKU - FINLAND, 19 December 2018 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, today announces interim results from its pharmacokinetic/dynamic "YODA" study, examining various formulations of recombinant human interferon-beta ("IFN-beta").
Further to the Company's announcement on 22 October 2018, the YODA study, in around 50 healthy volunteers, is being undertaken to understand the reduced biomarker response to Traumakine during the phase III INTEREST trial. YODA trial results from the first 30 subjects indicate that IFN-beta, regardless of the method of solubilisation, produced the expected level of bioactivity suggesting that drug formulation was not a factor in the outcome of the INTEREST trial.
The YODA study will now examine concomitant administration of prednisolone and Traumakine in order to confirm, in vivo, the observed interference of corticosteroids on IFN-beta bioactivity in the INTEREST study and ex vivo lung samples. These YODA results are expected during Q1 2019.
Dr Markku Jalkanen, CEO of Faron, said: "We believe these results confirm that the drug product used in the INTEREST study was robust and effective. While analysis continues, we believe the mixed results seen were due to a higher than anticipated placebo response due to high pneumonia portion, interference of corticosteroids on IFN-beta bioactivity and, as recently announced, the impact of a subgroup of patients' single nucleotide polymorphism C/T mutation in their interferon alpha and beta receptor gene."
The company continues to await top-line data from the Phase III ARDS trial with Japanese partner Maruishi (JapicCTI-163320) to help determine next steps for Traumakine's development. These data, originally expected before the end of year, are now anticipated by Faron in early 2019.
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 Ltd
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com
Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@consilium-comms.com
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: chris.brinzey@westwicke.com
Panmure Gordon (UK) Limited, Nomad and Broker
Emma Earl, Freddy Crossley
Phone: +44 207 886 2500
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company's lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies. There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com