TIDMERGO
Ergomed plc
02 April 2020
RNS REACH
PRESS RELEASE
Update on Siltuximab Clinical Study: Interim Analysis Data for
Siltuximab-Treated COVID-19 Patients
Guildford, UK - 2 April 2020: Ergomed plc (LSE: ERGO) ('Ergomed'
or the 'Company'), a company focused on providing specialised
services to the pharmaceutical industry, notes the recent update
provided by EUSA Pharma (EUSA) concerning the study of siltuximab,
an interleukin (IL)-6 targeted monoclonal antibody, for the
treatment of patients with COVID-19 who have developed serious
respiratory complications (Siltuximab In Serious COVID-19; SISCO
Study). Yesterday EUSA announced initial preliminary findings from
the SISCO Study, based on a pre-planned data analysis on 24 March
2020.
As previously announced the study is sponsored by the Papa
Giovanni XXIII Hospital in Bergamo, Italy and supported by EUSA.
Ergomed is providing clinical development and research services for
the study and has been integrally involved in the design and
implementation of the study from a clinical and operational
perspective. See details of full announcement below.
Dr Miroslav Reljanović, Executive Chairman of Ergomed, said: "We
are pleased to see the preliminary data which will help inform the
most appropriate use of siltuximab in patients with COVID-19
suffering from serious respiratory complications. We continue to
provide clinical development and research services, working closely
with the investigators at the Papa Giovanni XXIII Hospital and with
EUSA. We look forward to the completion of the study and the
insights it might bring for the development of a treatment for
COVID-19."
The full text of the announcement issued by EUSA on 1 April is
as follows:
EUSA Pharma and Papa Giovanni XXIII Hospital, Italy, Provide
Interim Analysis Data for Siltuximab-Treated COVID-19 Patients from
the SISCO Study
HEMEL HEMPSTEAD, United Kingdom & BERGAMO, Italy - 1(st)
April 2020 - EUSA Pharma, a global biopharmaceutical company
focused on oncology and rare disease, today announced initial
preliminary findings from the Papa Giovanni XXIII Hospital
sponsored SISCO (Siltuximab In Serious COVID-19) Study,(1) based on
a pre-planned data analysis on 24 March 2020.
Siltuximab is an interleukin (IL)-6 targeted monoclonal antibody
approved by the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) as well as in a number of other
jurisdictions worldwide for the treatment of patients with
multicentric Castleman disease (MCD) who are human immunodeficiency
virus (HIV) negative and human herpesvirus-8 (HHV-8) negative (also
known as idiopathic MCD; iMCD). Siltuximab is under investigation
for COVID-19 patients who have developed serious respiratory
complications, the leading cause of morbidity and mortality.
The interim data, presented from the first 21 patients treated
with siltuximab and followed for up to 7 days, show that one-third
(33%, n=7) of patients experienced a clinical improvement with a
reduced need for oxygen support and 43% (n=9) of patients saw their
condition stabilise, indicated by no clinically relevant changes.
Combined, this means that over three-quarters of patients treated
with siltuximab (76%, n=16) had either stable or improved disease
at this interim analysis. A worsening of the disease was seen in 3
(14%) patients whilst 1 (5%) patient died and 1 (5%) experienced a
cerebrovascular event.
Furthermore, C-Reactive Protein (CRP) levels, a marker of
systemic inflammation, declined from baseline through to Day 5
following treatment with siltuximab in all patients with sufficient
recorded values (100%, 16/16). This level of reduction was
maintained in those patients (100%, 16/16) 7 days after receiving
treatment with siltuximab. Reduction in CRP is considered a robust
surrogate for indicating the efficacy of IL-6 inhibition.(2)
The majority (90%, 19/21) of patients presented with fever at
baseline, 13/21 (62%) with a dry cough and 15/21 (71%) with
dyspnoea (shortness of breath). Partial pressure of arterial oxygen
(PaO(2) ) to percentage of inspired oxygen (FiO(2) ), otherwise
known as the P/F ratio or lung function, and IL-6 had out of normal
ranges at baseline in the majority of patients with a median P/F
ratio of 127 (excluding those >300 and indicating Acute
Respiratory Distress Syndrome [ARDS](3) ) and median peripheral
IL-6 levels of 140 pg/mL (range 113-239 pg/mL). Serum CRP was
elevated in all patients at baseline with a median of 23 mg/dL
(range 10-43 mg/dL).
A manuscript is in preparation for submission to a leading
medical journal, and the pre-print summary has been deposited and
will be available via medRxiv.org imminently.
Professor Alessandro Rambaldi, MD, PhD, Papa Giovanni XXIII
Hospital, Bergamo, Italy, Study Sponsor-Investigator and Director
of the Hematology Unit and Department of Oncology and Hematology ,
said: "The team at Papa Giovanni XXIII Hospital are pleased to
share these preliminary observational data. Whilst we are yet to
identify and analyse the control group of patients, these initial
data in siltuximab-treated patients provide vital information to
guide decisions regarding appropriate use of siltuximab in both the
real-world and new COVID-19 studies as we continue to investigate
the role IL-6 blockade can play. Importantly, these preliminary
uncontrolled data confirm high levels of IL-6 at baseline, with
baseline CRP also high but declining with siltuximab treatment,
suggesting a role for monoclonal antibodies as a possible
therapeutic strategy for this fatal infectious disease. Further
data will be made available on remaining patients, the case-control
analysis and 30 day follow-up of mortality as they become
available."
Lee Morley , Chief Executive Officer, EUSA Pharma, said: "We are
very pleased to be able to release these preliminary data from the
SISCO Study and hope the findings will help to guide real-world
treatment decisions during this critical emergency situation. We
look forward to engaging in further studies to research the
potential of siltuximab for patients suffering severely with
respiratory complications from COVID-19 and making additional data
available as soon as possible. We are very grateful to the team at
Papa Giovanni XXIII Hospital in Bergamo, Italy, for their
extraordinary efforts to undertake the SISCO Study and collate
these interim data under extremely difficult circumstances."
About the SISCO Study
Sponsored by the Papa Giovanni XXIII Hospital, the SISCO Study
is an observational case-control trial of siltuximab, a chimeric
monoclonal antibody targeting human IL-6, for the treatment of
COVID-19 patients who develop serious respiratory complications.
Ergomed plc (LSE: ERGO), a company focused on providing specialised
services to the pharmaceutical industry, is providing clinical
research services for the study.
The study represents the data collection and analysis of a
series of patients treated under an ongoing emergency compassionate
use protocol. The study is investigating two cohorts
retrospectively, hospitalised patients prior to admission to an
intensive care unit (ICU) or patients already requiring intensive
care, and will compare to matched controls. Primary endpoints are
reduction in the need of invasive ventilation, time spent in ICU or
30-day mortality.
Emerging evidence suggests that some patients with COVID-19 may
respond with overproduction of IL-6, an inflammatory cytokine,
leading to a cytokine storm - when the immune system becomes
over-stimulated and attacks the patient's own body. Elevated IL-6
levels are associated with severity of disease and can lead to
serious lung complications and/or Acute Respiratory Distress
Syndrome (ARDS) - the leading cause of mortality in patients with
COVID-19. Therefore, direct targeting of this cytokine may improve
clinical outcomes in these critically ill patients.
The SISCO study has enrolled a total of 25 patients with
confirmed SARS-CoV-2 infection (COVID-19) and respiratory
complications of which preliminary data is presented from the first
21 treated with siltuximab. All patients in the study were treated
with siltuximab at a dose of 11mg/kg infused over 1 hour with a
second dose possible at physician discretion. Of the 21 patients
treated with siltuximab, 5 received a second dose (5/21; 24%) 48-72
hours following the initial infusion.The majority of patients were
male (18/21, 86%) with ages ranging from 48 to 75 years. The most
prevalent comorbidities in this group of patients were:
hypertension in 43% (9/21), cardiovascular disease in 19% (4/21),
diabetes in 24% (5/21) of patients, respectively.
This study will provide important data to inform future clinical
studies, discussions on which are ongoing, to further investigate
the efficacy of siltuximab in patients with COVID-19 who develop
serious respiratory complications. Initial data have been announced
today. The next phase of data, which will compare outcomes in
matched case-control patients not treated with siltuximab, is
expected in the coming weeks.
References
1 SISCO Study (NCT04322188);
https://www.clinicaltrials.gov/ct2/show/NCT04322188
2 Clin Cancer Res; 21(6) March 15, 2015
https://clincancerres.aacrjournals.org/content/21/6/1248.long
3 JAMA, 307 (23), 2526-33 2012:
https://jamanetwork.com/journals/jama/article-abstract/1160659
#S#
About siltuximab
Siltuximab is a monoclonal antibody that blocks the action of
interleukin (IL)-6, a multifunctional cytokine detected at elevated
levels in multiple inflammatory conditions.
It is approved by the U.S. Food and Drug Administration (FDA)
and the European Medicines Agency (EMA) as well as in a number of
other jurisdictions worldwide, under the brand name SYLVANT(R) ,
for the treatment of patients with multicentric Castleman disease
(MCD) who are human immunodeficiency virus (HIV) negative and human
herpesvirus-8 (HHV-8) negative (also known as idiopathic MCD;
iMCD). iMCD is a rare, life-threatening and debilitating
lymphoproliferative disorder, which causes abnormal overgrowth of
immune cells and shares many symptomatic and histological features
with lymphoma.
Siltuximab is not approved for the treatment of COVID-19.
EUSA Pharma has exclusive rights to SYLVANT(R) globally. EUSA
Pharma has granted BeiGene, Ltd., exclusive development and
commercialisation rights to SYLVANT(R) in Greater China.
Indications and Usage of SYLVANT(R) - See full Prescribing
Information for additional information .
SYLVANT(R) (siltuximab) is indicated for the treatment of
patients with multicentric Castleman disease (MCD) who are HIV
negative and HHV-8 negative.
Limitations of Use: SYLVANT(R) was not studied in patients with
MCD who are HIV positive or HHV-8 positive because SYLVANT(R) did
not bind to virally produced IL-6 in a nonclinical study.
Contraindications : Severe hypersensitivity reaction to
siltuximab or any of the excipients in SYLVANT(R) .
Dosage and Administration
Administer SYLVANT(R) 11 mg/kg over 1 hour as an intravenous
infusion every 3 weeks until failure.
Perform hematology laboratory tests prior to each dose of
SYLVANT(R) therapy for the first 12 months and every 3 dosing
cycles thereafter. If treatment criteria outlined in the
Prescribing Information are not met, consider delaying treatment
with SYLVANT(R) . Do not reduce dose.
Do not administer SYLVANT(R) to patients with severe infections
until the infection resolves.
Discontinue SYLVANT(R) in patients with severe infusion related
reactions, anaphylaxis, severe allergic reactions, or cytokine
release syndromes. Do not reinstitute treatment.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class
biopharmaceutical company focused on oncology and rare disease. The
company has extensive commercial operations in the United States
and Europe, alongside a direct presence in select other markets
across the globe. EUSA Pharma is led by an experienced management
team with a strong record of building successful pharmaceutical
companies, and is supported by significant funding raised from
leading life science investor EW Healthcare Partners. For more
information please visit: www.eusapharma.com .
About Papa Giovanni XXIII Hospital
Papa Giovanni XXIII Hospital is one of the biggest hospitals in
Lombardy, covering 320 thousand square meters in total and
comprising more than 900 beds. Among the areas of excellence, an
important role is covered by the Cancer Center that brings patients
from the whole national territory and also from foreign countries.
The Hospital is playing a leading role in the Italian response to
the ongoing global COVID-19 pandemic.
ENDS
Enquiries:
Ergomed plc Tel: +44 (0) 1483 402
975
Miroslav Reljanović (Executive Chairman)
Richard Barfield (Chief Financial Officer)
Numis Securities Limited Tel: +44 (0) 20 7260 1000
Freddie Barnfield / Huw Jeremy (Nominated
Adviser)
James Black (Broker)
Consilium Strategic Communications - for Tel: +44 (0) 20 3709 5700
UK enquiries
Chris Gardner / Sue Stuart ergomed@consilium-comms.com
Matthew Neal / Olivia Manser
About Ergomed plc
Ergomed provides specialist services to the pharmaceutical
industry spanning all phases of clinical development, post-approval
pharmacovigilance and medical information. Ergomed's fast-growing,
profitable services business includes an industry leading suite of
specialist pharmacovigilance (PV) solutions, integrated under the
PrimeVigilance brand, a full range of high-quality contract
research and trial management services under the Ergomed brand
(CRO), and an internationally recognised specialist expertise in
orphan drug development, under PSR. For further information, visit:
http://ergomedplc.com .
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END
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