REG - Shield Therapeutics - Results from Phase 3 paediatric study

Shield TherapeuticsAnnouncement

25/09/2024 07:00

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RNS Number : 4852F  Shield Therapeutics PLC  25 September 2024

  Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

Results from Phase 3 paediatric study

 

Pivotal Trial of ACCRUFeR®/FeRACCRU® (ferric maltol) in Paediatric Patients
with Iron Deficiency Anemia (IDA)

proves highly clinically relevant effectiveness

 

Data will be used to support filing obligations with the US FDA and the
European EMA for a paediatric indication in children older than 1 month for
ACCRUFeR®/FeRACCRU® in H1 2025

 

London, UK, 25 September 2024: Shield Therapeutics plc (LSE: STX), the
commercial stage pharmaceutical company specialising in iron deficiency,
announces results from the Phase 3 paediatric clinical trial
(FORTIS/ST10-01-305), confirming the efficacy, safety, and tolerability of the
new oral liquid paediatric suspension in children with iron deficiency anaemia
(IDA).

 

This trial is the final study in the comprehensive development program
supporting the paediatric investigation plan (PIP/PSP) agreed with the
European EMA and the US FDA. The full data set, including pharmacokinetic (PK)
sub-study parameters, will be submitted for peer-review and subsequent
presentation/publication. The data will be used to support a filing with the
US FDA and European EMA for a paediatric indication in children older than 1
month for ACCRUFeR®/FeRACCRU® in H1 2025.

 

Additionally, Shield is due a total of €1 million as development milestones
from its European partner, Norgine BV, upon the compliance notification of the
PIP by the Pediatric Committee (PDCO) and the granting of the paediatric
indication by EMA.

 

All primary endpoints were met, and the outcomes were:

 

·    Change in Hb concentration from baseline to week 12: Patients in the
ferric maltol group demonstrated a highly clinically relevant mean change in
Hb concentration at week 12 compared to baseline.

o  The mean change was 1.25 g/dl from baseline to week 12 in the 2 -
17-year-old cohort and was 1.77 g/dl from baseline to week 12 in the infants

o  The mean change was 1.15 g/dl from baseline to week 12 in patients in the
ferrous sulphate group.

 

·    Frequency of discontinuations from the study because of Treatment
Emergent Adverse Events (AEs):  No patients in the ferric maltol group
discontinued from the study as a result of AEs.

o  In the 2 - 17-year-old cohort, no patient (0/31; 0%) discontinued the
ferric maltol treatment due to an AE compared to one patient (1/30; 3.3%) who
discontinued from the ferrous sulphate arm.

o  None of the infants discontinued ferric maltol treatment due to an AE.

 

·    Frequency of AEs/serious adverse events (SAEs): No patient in the
ferric maltol group reported a treatment related SAE and two (2) patients
reported treatment related AEs.

o  No treatment related SAEs were reported in either group.

o  In the 2 - 17-year-old cohort, treatment related AEs were reported in 2
out of 31 patients treated with ferric maltol compared to 4 out of 30 patients
treated with ferrous sulphate.

o  None of the ferric maltol-treated infants reported treatment related AEs .

 

Anders Lundstrom, interim CEO commented: "We are delighted that the results in
this important ACCRUFeR®/FeRACCRU® Paediatric Phase 3 study show similar
levels of efficacy and safety as in prior trials with adults. We will now
initiate the work with the regulatory applications to be able to expand the
patient population who can benefit from a safe and effective oral iron
treatment."

 

Professor Richard Russell, a FORTIS Principal Investigator, commented: "These
results indicate that the newly developed paediatric liquid formulation will
provide a welcome additional well-tolerated and effective therapeutic option
for the treatment of IDA in young children and adolescents."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel/Patrick Birkholm                                                                   +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Rory Sale/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 Financial PR & IR Advisor
 Walbrook PR
 Charlotte Edgar / Alice Woodings                                                               +44 (0)20 7933 8780 or shield@walbrookpr.com (mailto:shield@walbrookpr.com)

 

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for adults of all ages, across multiple therapeutic areas. Together,
ID and ID with anemia (IDA) affect about 20 million people in the US and
represent a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet
medical need for both physicians and patients.

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. The drug has a novel mechanism of absorption
compared to other oral iron therapies and has been shown to be an efficacious
and well-tolerated therapy in a range of clinical trials. More information
about ACCRUFeR®/FeRACCRU®, including the product label, can be found at:
www.accrufer.com (http://www.accrufer.com) and www.feraccru.com
(http://www.feraccru.com) .

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration
agreement with Viatris. Outside of the U.S., the Company has licensed the
rights to four specialty pharmaceutical companies. FeRACCRU® is
commercialized in the UK and European Union by Norgine B.V., which also has
marketing rights in Australia and New Zealand. Shield also has an exclusive
license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the
development and commercialization of ACCRUFeR®/ FeRACCRU® in China, Hong
Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea,
and with KYE Pharmaceuticals Inc. for Canada.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

Forward-Looking Statements

This press release contains forward-looking statements. All statements
contained in this press release that do not relate to matters of historical
fact should be considered forward-looking statements.  These forward-looking
statements are based on management's current expectations and include
statements related to the commercial strategy for ACCRUFeR®/FeRACCRU®. These
statements are neither promises nor guarantees, but involve known and unknown
risks and uncertainties, many of which are beyond our control, that may cause
actual results and performance or achievements to be materially different from
management's expectations expressed or implied by the forward-looking
statements, including, but not limited to, risks associated with the Company's
business and results of operations, competition and other market factors.
The forward-looking statements made in this press release represent
management's expectations as of the date of this press release, and except as
required by law, the Company disclaims any obligation to update any
forward-looking statements contained in this release, even if subsequent
events cause its views to change.

 

Details of the FORTIS/ST10-01-305 Phase 3 study

The open label randomized Phase 3 study included children aged 1 month to 17
years with mild to moderate iron-deficiency anaemia (IDA), who also had serum
ferritin levels below 30 μg/L or ferritin levels below 50 μg/L and
transferrin saturation below 20%.  Children aged 2 to 17 years were
randomized 1:1 to receive either ferric maltol (N=31) or ferrous sulphate (N =
30).  Children 1 month to under 2 years (N=4, and 3 were treated) were all
assigned to receive ferric maltol treatment. The study was not powered to
detect a statistical difference in primary endpoints between ferric maltol and
the ferrous sulphate comparator group.

 

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