Important New Trial With Oral FERACCRU® Shows Comparable Efficacy to IV Iron (Ferric Carboxymaltose), Offering a Real Alternative to Hospital Administration for Many Patients[4]

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04 Mar, 2019, 12:08 GMT

AMSTERDAM, March 4, 2019 /PRNewswire/ --

FERACCRU^®(Ferric Maltol) met primary endpoint against Ferinject® (IV Ferric Carboxymaltose (FCM)) and shows clear benefits to Iron Deficiency Anaemia (IDA) patients with inactive Inflammatory Bowel Disease (IBD)⁴
FERACCRU® delivered a haemoglobin (Hb) response rate at 12 weeks that was within 9% of the effect seen with a market leading IV iron treatment (IVI FCM), but without the need for hospital-based administration⁴
FERACCRU® was efficiently absorbed and well tolerated over the extended treatment period, in line with previous studies²

Shield Therapeutics plc (Shield) and Norgine B.V. (Norgine) today announced positive results from the AEGIS Head-to-Head (H2H) clinical trial, which compared FERACCRU® (ferric maltol), a novel oral iron replacement therapy, to Ferinject® (ferric carboxymaltose (FCM)), a market-leading intravenously delivered iron replacement therapy⁴.

In the AEGIS-H2H study, ferric maltol demonstrated increases in the mean Hb levels that were comparable to IV FCM. Patients with Iron Deficiency Anaemia (IDA), whose Inflammatory Bowel Disease (IBD) is inactive now have an important alternative treatment option, which is both effective over the long term and well tolerated, therefore reducing the need for time-consuming and expensive hospital administration. Current oral iron treatments can be poorly tolerated and don't always work⁷, which leads to many unwell patients having to receive IV iron in hospital.

"The results of this study provide an important opportunity to change clinical practice to improve patients' lives. Patients with inactive Inflammatory Bowel Disease who are unwell as a result of Iron Deficiency Anaemia have often tried a number of oral iron treatments which didn't work or they couldn't tolerate," commented Dr Alastair Benbow, Chief Medical and Development Officer at Norgine. "Previously, they would have needed to go to hospital for time-consuming and expensive IV administration. Now many patients can be treated at home with an effective and well-tolerated oral iron alternative," he added.

More detailed analyses of the data, including the secondary endpoints and safety parameters, will be presented at Shield's upcoming presentation of its preliminary results for 2018, scheduled for early April 2019, whilst the full data will be submitted for peer-review and subsequent presentation by the study's lead investigators at upcoming scientific meetings.

FERACCRU® is a novel, effective and well tolerated treatment, which 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)^1-3. A New Drug Application in the USA is being reviewed by the FDA with a PDUFA date of 27 July 2019.

On 19 September 2018, Norgine entered into an exclusive licence agreement with Shield Therapeutics plc for the commercialisation of the product in Europe, Australia and New Zealand.

www.norgine.com

Notes to Editors:

About IDA in IBD

Iron deficiency anaemia (IDA) is frequently seen in inflammatory bowel disease (IBD). Characteristic symptoms of anaemia include chronic fatigue, headache, and subtle impairment of cognitive function.

IDA is difficult to treat, partly because many patients are intolerant to traditional oral iron therapies⁵. Currently, the only treatment option for IDA patients who cannot tolerate oral iron therapies is IV iron therapy. IV iron therapies, however, can be time and resource consuming to administer. They may also come with potentially life-threatening, spontaneous hypersensitivity reactions⁶.

In the AEGIS-H2H study, ferric maltol demonstrated increases in Hb levels that were comparable to IV FCM and now offers an important alternative option for these patients, maintaining efficacy with good tolerability, without the need for hospital administration⁴.

About the AEGIS Head-to-Head (H2H) study

The 52 week AEGIS–H2H Phase 3b study compared the efficacy of oral ferric maltol to IVI FCM in the treatment and maintenance of IDA in subjects with inactive IBD in whom other oral iron therapies had failed⁴.

This was a multi-national Phase IIIb randomised, active-controlled trial in 242 patients across USA and Europe with haemoglobin (Hb) measurements as low as 8.0g/dL. The objective of the study was to assess whether the effect of ferric maltol on Hb levels (defined by the protocol as normalisation of Hb or a >2g/dL rise in Hb from baseline) was comparable to the effect seen with IVI FCM treatment at 12 weeks. This was followed by a 40-week extension phase, during which eligible subjects continued treatment with ferric maltol or received IVI FCM in line with clinical need as described in IVI FCM's Summary of Product Characteristics in the EU and its Prescribing Information in the USA.

Primary analysis of the AEGIS-H2H dataset has shown that the Hb response rate to ferric maltol was within 9% of the response rate seen with FCM, and comparable to the increase observed in the original AEGIS-IBD study². The primary endpoint of the study was defined as the Lower Confidence Limits being less than 20% different for ferric maltol versus IVI FCM and statistical analysis of this endpoint provides a positive p value of 0.022⁴.

Secondary endpoints included assessment of Hb response to both therapies and measurement of key iron storage parameters through 52 weeks as well as the usual safety assessments.

For further information about the trial, including inclusion and exclusion criteria, please contact us.

About FERACCRU^®

Ferric maltol is a novel oral ferric iron therapy for the treatment of iron deficiency (ID) in adults. The recommended dose is one capsule (30mg) taken twice a day, morning and evening, on an empty stomach. Treatment duration depends on the severity of the iron deficiency (ID), but generally at least 12 weeks of treatment are required. Ferric maltol normalises and maintains Hb levels, limiting the need for intravenous (IV) iron treatment to patients with Hb levels <9.5g/dl¹.

In the original Phase III AEGIS IBD clinical trial programme, which led to the license being granted, the efficacy and tolerability of ferric maltol was assessed in the treatment of IDA in patients with inactive IBD versus placebo, who had previously failed to respond, or had been intolerant to previous oral ferrous products (OFP). Ferric maltol was shown to be effective and well-tolerated at both 12 and 64 weeks².

About Norgine

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. Norgine specialises in gastroenterology, hepatology, cancer and supportive care. In 2017, Norgine's total net product sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

About Shield Therapeutics plc

Shield is a de-risked, commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs. The Company's clear purpose is to help its patients become people again, by enabling them to enjoy the things that make the difference in their everyday lives. The Group has a marketed product, Feraccru®, for the treatment of iron deficiency in adults which has exclusive IP rights until the mid-2030s. Feraccru® is commercialised in the European Union by Norgine BV and the US Food and Drug Administration (FDA) is currently considering a New Drug Application (NDA), with a PDUFA (Prescription Drug User Fee Act) date of 27th July 2019. For more information please visit www.shieldtherapeutics.com.

References

Summary of Product Characteristics, Shield Pharmaceuticals March 2018. Available at: https://www.medicines.org.uk/emc/medicine/31722 Accessed March 2019
Gasche C, et al. Inflamm Bowel dis 2015; 21 (3): 579-588 Available at https://www.ncbi.nlm.nih.gov/pubmed/25545376 Accessed March 2019
Schmidt C, et al. Aliment Pharmacol Ther 2016;44 (3): 259-270 Available at https://www.ncbi.nlm.nih.gov/pubmed/27237709 Accessed March 2019
Shield Study ST10-01-304 Headline Results 4th March 2019: "A phase 3b, randomized, controlled, multicentre study with oral ferric maltol or intravenous ferric carboxymaltose, for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease"
Biancone et al. J Crohn's and Colitis 2008; 2: 63-92.
Ferinject SmPC November 2018 https://www.medicines.org.uk/emc/product/5910/smpc#CLINICAL_PRECAUTIONS
Lugg et al. 2014 Journal of Crohn's and Colitis 8, 876–880