Silence Therapeutics PLC SLN124 granted Orphan Drug Designation by EMA (0750N)
15 January 2019 - 6:00PM
UK Regulatory
TIDMSLN
RNS Number : 0750N
Silence Therapeutics PLC
15 January 2019
SLN124 granted Orphan Drug Designation by EMA for the treatment
of <BETA>-Thalassemia
January 15, 2019
LONDON, Silence Therapeutics, PLC (LON: SLN) ("Silence" or "the
Company") a leader in the discovery, development and delivery of
novel RNA therapeutics for the treatment of serious diseases,
announces that its lead medicine candidate SLN124 has been granted
Orphan Drug Designation by the Committee for Orphan Medicinal
Products (COMP), the European Medicines Agency's (EMA) committee
responsible for recommending orphan designations of medicines for
rare diseases. This positive COMP decision has been adopted by the
European Commission.
Following an application by Silence last year, the COMP
concluded that SLN124 will be of significant benefit to those
affected by the chronic and potentially life-threatening condition,
<BETA>-Thalassemia. By receiving Orphan designation, SLN124
can benefit from expediated clinical development and ten years of
market exclusivity, subject to approval. The COMP decision follows
positive feedback from the UK Medicines and Healthcare products
Regulatory Agency (MHRA) Scientific Advice meeting in June last
year.
SLN124, which has been shown to lower serum iron levels and
modulate tissue iron distribution in rodent models for
<BETA>-Thalassemia and hereditary hemochromatosis, represents
a promising therapeutic candidate for treating patients with iron
overload disorders, including <BETA>-Thalassemia,
myelodysplastic syndrome (MDS) and hereditary hemochromatosis.
Dr. David Horn Solomon, Chief Executive Officer of Silence
Therapeutics, commented:
"We are pleased to receive Orphan Drug Designation for our iron
overload disorder candidate, SLN124, which will assist in
expediting clinical development as we progress our Phase Ib trial
planned to begin in H2 2019. We believe that this innovative
product offers significant promise for patients with iron overload
disorders such as <BETA>-Thalassemia, MDS and hereditary
hemochromatosis and we look forward to rapidly advancing SLN124
through clinical development."
Enquiries:
Silence Therapeutics plc Tel: +44 (0)20 3457
Dr David Horn Solomon, Chief Executive 6900
Officer
Peel Hunt LLP (Nominated Adviser and Broker) Tel: +44 (0)20 7418
James Steel/Oliver Jackson 8900
European IR Tel: +44 (0) 20
Consilium Strategic Communications 3709 5700
Mary-Jane Elliott / Angela Gray
silencetherapeutics@consilium-comms.com
US IR Tel: +1 (443) 213-0505
Westwicke Partners
Peter Vozzo
peter.vozzo@westwicke.com
About Silence Therapeutics plc
Silence Therapeutics is developing a new generation of medicines
by harnessing the body's natural
mechanism of RNA interference, or RNAi, within its cells. Its
proprietary technology can selectively
inhibit any gene in the genome, specifically silencing the
production of disease-causing proteins. Using
its enabling delivery systems, it has achieved an additional
level of specificity by delivering its
therapeutic RNA molecules exclusively to target cells. Silence's
proprietary RNA chemistries and
delivery systems are designed to improve the stability of our
molecules and enhance effective delivery
to target cells, providing a powerful modular technology well
suited to tackle life-threatening diseases.
For more information, please visit:
https://www.silence-therapeutics.com/
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END
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