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Shield Therapeutics slumps as flagship drug fails pivotal Phase III trial

Feraccru is already available to treat iron deficiency anaemia (IDA) in patients with irritable bowel disease, but Shield was trying to show that it is effective at treating IDA in people with chronic kidney disease as well

doctor with a test tube
Feraccru was not significantly more effective than a placebo in the AEGIS-CKD study

Shares in Shield Therapeutics PLC (LON:STX) halved in value on Monday after the speciality pharma group revealed its lead product, Feraccru, had failed a pivotal Phase III trial.

Shield had been testing Feraccru as a treatment of iron deficiency anaemia (IDA) in patients with chronic kidney disease.

No more effective than a placebo​

But top-line data from the AEGIS-CKD study showed that Feraccru was no more effective than a placebo in boosting a patient’s levels of haemoglobin – the chemical in the blood which carries oxygen.

There had been signs at the half-way point of the trial that Feraccru was having an effect, although that wasn’t sustained through to the end of the study at week 16.

The patient drop-out rate was low over 16 weeks and similar in both arms, which Shield said reconfirmed Feraccru’s strong tolerability profile.

“We are surprised and disappointed by these top-line findings,” said chief executive Carl Sterritt.

“Feraccru has previously demonstrated positive efficacy and safety in IBD patients, which led to it being approved in Europe where it continues to gain commercial traction.

“We now await the full dataset in order to fully understand the study's outcome and define the next steps in our strategy.”

What's next?​

As Sterritt said, the plan now is to wait for the full set of results to come in so Shield can understand where things went wrong.

In the meantime, a Phase IIIb trial comparing the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron is underway, the data from which is expected in the second half.

On top of that, a decision from European regulators about allowing Feraccru as a treatment for all patients with IDA is due in this half. If the outcome is positive, Shield reckons it could “significantly expand the market opportunity” for the treatment in Europe.

Shield shares dived 51.1% to 55p.

Quick facts: Shield Therapeutics PLC

Price: 185 GBX

LSE:STX
Market: LSE
Market Cap: £216.8 m
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Shield's Feraccru likely to command 'high market share and branded pricing'

Capital Network analyst Emma Ulker assesses recent progress made at Shield Therapeutics PLC (LON:STX) with its lead asset Feraccru. The drug's approved and marketed in Europe, with a US approval decision pending for July 27. Feraccru is an oral product absorbed in the gut. It's also...

on 11/5/19

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