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Shield Therapeutics PLC: Hitting its clinical targets

Shield Therapeutics PLC: Hitting its clinical targets

Shield Therapeutics (LON:STX) has reported further data from its non-inferiority AEGIS H2H study of oral ferric maltol (branded as Feraccru in Europe and Accrufer in US) versus intravenous ferric carboxymaltose (IV FCM), which is the standard second-line treatment for iron deficiency anaemia (IDA). The data from the multi-national Phase 3b randomised trial in inflammatory bowel disease (IBD) patients with IDA, supported the headline data reported in March, providing additional material to support commercialisation and reimbursement efforts in a global iron replacement market worth circa US$3bn.

 

The data, which were presented at the 27th United European Gastroenterology Week (UEG) by Dr Stefanie Howaldt, principal investigator of the AEGIS trial, included additional detail on the longer-term data out to 52 weeks and confirmed not only that the primary endpoints were met, but that Feraccru prevented the recurrence of IDA, providing a real oral alternative to IV iron. These outcomes provide strong support for the positioning of STX’s oral treatment for current and potential partners including in a broad preventative setting.

Key outcomes
  • The H2H study of Feraccru (oral ferric maltol) versus IV FCM showed non-inferiority in response rate, defined as an increase or normalisation of haemoglobin levels at week-12.
  • The response rate was 74% for oral ferric maltol and 83% for IV FCM, providing statistically significant (p=0.017) evidence of a response rate well within the 20% non-inferiority margin.
  • Sustained 52-week treatment with Feraccru prevented recurrence of IDA, while 49 (39%) subjects on IV iron relapsed and collectively required 69 additional IV infusions.
  • Feraccru again demonstrated it was effective and well-tolerated, even in a patient group unable to tolerate first-line oral iron salts.

Conclusions

  • The data are supportive of Feraccru and present a clear commercial challenge to market-leading IV iron products such as Ferinject in Europe (Injectafer in US), particularly given Feraccru’s convenience, as patients can take Feraccru at home, as well as avoiding the life-threatening risks associated with IV iron administration.
  • The study outcomes suggest that Feraccru offers a clear alternative to IV iron, prevents the relapse of IDA and the need for repeat IV iron infusions.

Background

Shield Therapeutics is a specialty pharmaceutical company focused on the development and commercialisation of late-stage pharmaceuticals. The company's lead asset, Feraccru, is an oral treatment for iron deficiency with or without anaemia. Feraccru is approved and marketed in Europe and was recently approved in the US to be marketed as Accrufer. It also has a pipeline of prescription pharmaceutical assets, the most advanced of which is PT20 a phase III-ready treatment for the electrolyte disorder, hypophosphatemia, which is extremely common in patients with chronic kidney disease.

Details of the study

The AEGIS H2H study was a randomised, active-controlled trial in inflammatory bowel disease (IBD) patients with iron deficiency anaemia. It recruited 250 subjects to compare oral Feraccru/Accrufer 30mg twice daily, for 52 weeks with IV ferric carboxymaltose (IV FCM) administered in line with the recommended dosing. The primary endpoint was the response rate defined as a rise in haemoglobin (Hb) ≥2g/dl or attainment of a normal Hb level at 12 weeks. The design was to measure non-inferiority of ferric maltol to IV FCM.

Study design
 
Source: Oral ferric maltol vs IV ferric carboxymaltose for IDA in IBD

AEGIS H2H endpoints were defined as follows;

 
 
Source: Oral ferric maltol vs IV ferric carboxymaltose for IDA in IBD

 

Comparing the response rate at 12 weeks, defined as the primary endpoint above, showed that the ferric maltol was non-inferior to the IV FCM. Non-inferiority was measured as a risk difference in responder rate within a 20% margin. The risk difference fell within this margin, making it a statistically significant outcome.

Responder rates at 12 weeks

 

 
 
Source: Oral ferric maltol vs IV ferric carboxymaltose for IDA in IBD

The comparison was extended out to 52-weeks and overall 39% of the IV FCM subjects needed additional IV infusions compared to one subject in the FM arm requiring IV iron due to a flare-up in IBD symptoms. The following chart illustrates this showing that the percentage of responders in the FM group outperformed the IV FCM group at weeks 24, 36 and 52, illustrating Feraccru’s long term benefit.

Outcomes from AEGIS H2H suggest that STX and its partners can in future position Feraccru as a preventative treatment

 
 
Source: Oral ferric maltol vs IV ferric carboxymaltose for IDA in IBD

A clear clinical and commercial rationale for Feraccru and Accrufer

In US Accrufer has a broader label than Vifor Pharma’s market-leading IV iron Injectafer which is indicated first for adults with IDA, for patients who have non-dialysis dependent CKD, and for patients who are intolerant, or who have an unsatisfactory response to oral irons, which could also favour Accrufer’s commercial prospects.

The outcomes from AEGIS H2H suggest that STX and its partners can in future position Feraccru as a preventative treatment; in other words, to maintain iron levels, which could, if taken up into treatment guidelines, broaden the uptake of Feraccru/Accrufer.

We contend that Feraccru can command a high market share as well as branded pricing because of its convenience and, supported by this additional clinical evidence, that it provides a long-term treatment for maintaining the body’s iron stores. Its convenience is a very important differentiator as patients can take Feraccru at home, avoiding hospital admission and the life-threatening risks of IV iron administration.

STX is very well placed to position Accrufer to potential partners given its non-inferiority and convenience

Blockbuster market potential

Vifor Pharma commercialises branded IV iron Ferinject in Europe and Switzerland, which is known as Injectafer in US. The global IV iron replacement market is reported to be valued at cUS$2bn, according to the latest data from IQVIA, while Ferinject holds approximately 50% of this market. This offers considerable potential for Feraccru. Its convenience could lead to better compliance and improved penetration, growing the overall market size.

Vifor reports that the IV iron markets for ID/IDA are relatively poorly penetrated, except for its home market Switzerland, providing high growth potential for the overall market in line with commercial efforts and reimbursement. Current penetration rates reported by Vifor and market research data (Beige Market Intelligence) suggest an overall IV and oral iron market size of up to US$3bn, and poor compliance with oral products is leading to a gradual switch to IV iron.

Given the poor penetration in many markets, including US, this suggests STX is very well placed to position Accrufer to potential partners, given its non-inferiority and greater convenience. It also positions it, in our view, to enter productive discussions with partners for China, given Ferinject is not yet launched, as well as bolstering market penetration in European markets through Norgine.

The ID patient pool in Europe alone is estimated to be up to 40mln and with a similar size in US. However, it might be logical to assume that CKD and IBD patients would form the initial targets. Active education, reimbursement and commercial roll-out can lead to an additional share of the wider markets, including the significant paediatric market of up to 1.6mln patients in Europe and US.

Unmet need in ID and IDA

Iron deficiency (ID) and iron deficiency anaemia (IDA) are caused by low levels of iron in the body. IDA is a common disorder: anaemia affects around 33% of the world’s population (source: WHO) and about half the cases are due to iron deficiency. Children and non-pregnant women are among the groups most affected. Commonly, ID is the precursor to IDA. Treatment of the first signs of ID can prevent progression. Moderate-to-severe IDA may cause fatigue or tiredness, breathing problems or chest pain. The most common reasons for ID are insufficient iron intake in the diet, an inability to absorb iron well in the body and/or loss of iron in blood through bleeding. Treating ID and IDA - which are common and often serious complications in people suffering with chronic heart or kidney disease, cancers or gastrointestinal diseases - can help improve patients’ symptoms and quality of life.

Quick facts: Shield Therapeutics PLC

Price: 95.2 GBX

LSE:STX
Market: LSE
Market Cap: £111.56 m
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