Faron Pharmaceuticals Oy Final results from YODA study (1801C)
14 June 2019 - 4:00PM
UK Regulatory
TIDMFARN
RNS Number : 1801C
Faron Pharmaceuticals Oy
14 June 2019
Faron Pharmaceuticals Oy
("Faron" or the "Company")
Final results from YODA study confirm previously reported
findings
TURKU - FINLAND, 14 June 2019 - Faron Pharmaceuticals Oy (AIM:
FARN), the clinical stage biopharmaceutical company, today
announces results from its pharmacokinetic/dynamic YODA study
examining the administration of concomitant steroids and Traumakine
in healthy volunteers.
As previously reported, the post-hoc analysis of the phase III
INTEREST study had indicated significant reduction of
interferon-beta ("IFN-beta") action by steroids and this finding
was also observed in the Japanese phase III study. Steroid
interference with IFN-beta was also reported in ex vivo human lung
tissues and human primary lung endothelial cells. The YODA study
was set out to further investigate this observed finding in a
prospective study setting in human healthy volunteers by
administrating Traumakine alone or Traumakine in combination with
prednisolone (a corticosteroid).
As previously announced, parts I and II of the YODA study
confirmed that the INTEREST study drug produced the expected levels
of bioactivity, suggesting that drug formulation was not a factor
in the outcome of the INTEREST trial and this observation was
confirmed during part III of the YODA trial. The concomitant use of
IFN beta-1a and prednisolone during part III reduced IFN beta-1a
action, compared to subjects who received IFN beta-1a alone. This
was evident during the YODA trial through both clinical signs of
the subjects (fever, which is a typical pharmacodynamic effect of
interferon beta-1a) and reduction of cluster of differentiation 73
(CD73) activity responses measured from blood samples of these
subjects. For the final statistical analysis, 10 subjects were
included in the Traumakine group (two drop outs due to strong "flu
reaction") and 12 subjects in the group receiving Traumakine in
combination with prednisolone. The statistical AUC (area under
curve) difference in CD73 activity between the two groups (10
versus 12 subjects) was p = 0.087. CD73 is regarded as the key
molecule to maintain the endothelial barrier, which if it leaks,
can cause impaired lung function and result in the life-threatening
syndrome, ARDS. Traumakine is designed to prevent this leakage by
upregulating CD73 expression.
Dr Markku Jalkanen, Chief Executive Officer of Faron, said:
"These YODA results once again are consistent with the INTEREST
data, supporting the conclusion that co-administration of steroids
with Traumakine in patients inhibited interferon beta action. These
findings are significant in explaining the lack of clinical
response to Traumakine in the INTEREST trial. The YODA report will
become an essential part of our communication dossier with the FDA
and EMA when we justify our clinical double dummy design for the
concomitant use of steroids for the next Traumakine studies."
The Company currently expects to receive the INFORAAA interim
results in the near future, allowing full review of all the
Traumakine data with key opinion leaders and to make final
decisions on Traumakine's development. The Company currently
envisages that a further Traumakine trial is likely to be funded
through third party funding. Low concomitant corticosteroid use is
expected during the INFORAAA trial.
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
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
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 first candidate Traumakine, to prevent vascular leakage
and organ failures, has completed a Phase III clinical trial in
Acute Respiratory Distress Syndrome (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 early 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
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END
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