Silence Therapeutics PLC (LON:SLN) bosses are looking forward to what should be an “exciting” nine months or so for the drug developer.
The company, which makes drugs that can ‘silence’ faulty genes, expects to begin its first-ever in-human trial in the second half of 2019 as it puts its SLN124 blood disorder treatment through its paces.
Away from the flagship SLN124 drug, Silence is also carrying out pre-clinical work on its SLN360 cardiovascular disease treatment and it started investigational new drug (IND) enabling studies last month.
Data from this will support an IND application further down the line, which firms need if they wish to start human trials.
Silence’s QPI-1002 programme has been out-licensed to California-based Quark Pharmaceuticals, which kicked off a phase III trial in acute kidney injury patients last July.
As well as all the progress in the lab, the company, which welcomed new boss David Horn Solomon last summer, has also recently scored a big victory in the courtroom.
Silence had been in a long-running dispute with US giant Alnylam which it claimed had ‘borrowed’ some of its intellectual property.
A settlement and license agreement were struck just before Christmas and Silence will receive a small tiered royalty on net sales of the US biotech group’s ONPATTRO drug in the EU.
Protecting its IP cost the company £4.0mln in 2018, which led to full-year losses widening to £18.4mln compared to a £1.6mln loss a year earlier when it benefited from the sale of its stake in US biopharma Arrowhead Pharmaceuticals.
Cash and cash equivalents stood at £26.5mln at the end of the year (2017: £42.7mln).
“2018 was a defining year for Silence Therapeutics, with transformational change throughout the business,” said chief executive David Horn Solomon.
“With the first RNAi therapeutics now approved by the FDA, effectively creating a new class of medicines, we are working hard to consolidate our position as a leading developer in this exciting new field.”
He added: “During the year we have made great progress in advancing our lead product SLN124 towards the clinic and we are due to commence in-human clinical trials later in 2019 to demonstrate safety and tolerability.”