The year-long phase IIIb study confirmed Feraccru’s “non-inferiority” to Ferinject when it came to boosting patients’ haemoglobin (Hb) levels.
Shield shares soared at the opening bell, jumping 25.2% to 67.9p.
So far, researchers have only had time to analyse the top-line data. More detailed analysis, such as secondary endpoints and safety parameters, will be presented alongside Shield’s full-year results in early April.
As part of its commercialisation agreement with Norgine BV, Shield will now receive a €2.5mln milestone payment.
“We are delighted that Feraccru has once again performed so well in a phase III clinical trial, this time delivering a major achievement in showing itself to be non-inferior to IV iron therapy, further reinforcing the value of Feraccru,” said chief executive and founder Carl Sterritt.
“These data provide yet further evidence that Feraccru is well-tolerated by a majority of treated patients and is effective at correcting both their iron deficiency and anaemia.”
Chief medical Mark Sampson added: “In a challenging phase IIIb clinical study, in which Feraccru has been tested against Ferinject, the standard of care for patients who cannot tolerate or are unwilling to take salt-based oral iron therapies, orally delivered Feraccru has demonstrated it is non-inferior to IV iron therapy in treating iron deficiency anaemia.”
US approval due in summer
Feraccru is approved and marketed in the European Union for the treatment of iron deficiency (ID) in adults and in Switzerland for the treatment of iron deficiency anaemia (IDA) in adults with inflammatory bowel disease (IBD).
A New Drug Application in the USA is being reviewed by the US Food and Drug Administration (FDA) which is set to return its verdict by the end of July.
Feraccru is a pill, which Shield thinks gives it an advantage over Ferinject which, as the name suggests, is an intravenous injection that needs to be administered in hospital.
It is also a non-salt treatment, which is important because when some salt-based oral iron therapies are ingested, they can cause nausea, bloating and constipation.
In the past, patients who could not tolerate salt-based tablets had to receive IV iron therapy – such as Ferinject – which Shield has said is “invasive, costly, inconvenient and complex to administer”.
Study de-risks commercial launch
“This successful study has triggered a €2.5mln milestone payment from Norgine and will allow [Shield] to begin reimbursement discussions across the rest of the EU thus de-risking the commercial launch that we believe is worth at least 56p per share and as much as 90p per share,” read a note from City broker Liberum.
“In the past year Shield has delivered an ultimately successful P3 in CKD, a major out-licensing deal with a significant upfront payment and now a successful read-out from the head to head study.
“The current market cap of just £63m is clearly not reflecting these achievements or the potential for US approval by the end of July.”
Liberum has Shield as a ‘buy’ with a target price of 116p.
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