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FOR
RELEASE ON
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17 February
2025
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THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES
OF THE UK VERSION OF THE MARKET ABUSE REGULATION (EU NO. 596/2014)
WHICH FORMS PART OF ENGLISH LAW BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018.
IP Group
plc - Portfolio company Istesso provides update on Phase 2b study
of leramistat in rheumatoid arthritis
· Results reinforce leramistat's novel mechanism of action (MOA)
and effectiveness in bone protection in people living with
rheumatoid arthritis (RA).
· Significant improvements were seen in the key secondary
endpoint of bone erosions as well as improvements in disability and
fatigue in patients treated with leramistat, despite the study not
meeting the primary endpoint of improvement in ACR20 versus
placebo.
· Results support further evaluation of leramistat's potential
to promote tissue repair in RA, as well as other chronic
conditions. Istesso is sufficiently funded to
conduct additional studies.
IP Group plc (LSE: IPO), which
invests in breakthrough science and innovation companies with the
potential to create a better future for all, is pleased to provide
the following update now that Istesso Limited has provided its
shareholders with the outcome of its Phase
2b study of leramistat in rheumatoid arthritis (RA).
The leramistat phase 2b study was a
12-week randomised, double-blind, placebo-controlled trial in
adults with moderate-severe RA and an inadequate response to
treatment with methotrexate. Although the study did not meet the
primary endpoint of improvements in ACR20 versus placebo,
leramistat did demonstrate statistically significant reductions in
the key secondary endpoint of bone erosions, as well as
improvements in disability and fatigue.1
Istesso highlighted that these
findings demonstrate leramistat's unique mechanism of action (MOA)
and support further evaluation of its potential to promote adaptive
tissue repair in combination with existing disease-modifying
anti-rheumatic drugs (DMARDs) in RA, as well as in other chronic
conditions.
Istesso also drew attention to the
fact that treatment with leramistat significantly reduced or
stopped the progression of bone erosions.1 Bone erosions
are a central feature of RA and appear early in the course of the
disease. Progression of bone erosions leads to bone damage and is a
major driver of disability and increased mortality in people living
with RA.2,3,4,5
Improvements in structural damage
were accompanied by statistically significant benefits seen in
reduced disability and fatigue for patients receiving leramistat
versus placebo.1 Fatigue in RA is widespread and its
impact debilitating, affecting quality of life and is often cited
as the primary cause of inability to work and job loss.6
Current treatment options are limited and there remains a huge
unmet clinical need.6
No new safety concerns were
identified in the study. The adverse event (AE) rate was similar
between groups receiving leramistat and placebo, and the majority
of AEs were mild in nature and resolved without
treatment.1 No deaths were reported and no significant
changes in clinical chemistry, bloods, vital signs or
cardiovascular health have been noted in leramistat trials to
date.7
Istesso will publish full study
results in due course and plans further Phase 2 studies to evaluate
leramistat's unique potential to promote adaptive tissue repair in
RA, as well as other chronic conditions. Istesso is sufficiently
funded to conduct these studies.
IP Group has an undiluted holding of
56.5% in Istesso and anticipates providing a further update
on Istesso, including its valuation, in its
2024 results that will be published next month.
Greg Smith, Chief Executive Officer
of IP Group, said: "We are encouraged that these results are
consistent with leramistat's unique mechanism of action which
supports and augments tissue repair. In addition, the impact on
disability and fatigue, from which a large proportion of RA
patients continue to suffer despite the widespread availability of
current medications, is also highly promising. Istesso will carry
out additional work to evaluate leramistat's potential to address
these unmet needs and to promote adaptive tissue repair in RA and
other chronic conditions, potentially in combination with existing
therapies. Based on these data, we continue to believe in the
market opportunity for leramistat to improve patients' health and
deliver significant value for shareholders."
For
more information, please contact:
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IP Group
plc
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www.ipgroupplc.com
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Liz Vaughan-Adams, Communications
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+44 (0) 20 7444 0062/+44 (0) 7967
312125
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Portland
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Alex Donaldson
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+44 (0) 7516 729702
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Notes for editors
About IP Group
IP Group accelerates the impact of science for a better
future. As the most active UK based, early stage science
investor, we develop and support some of the world's most exciting
businesses in deeptech, life sciences and cleantech (led by Kiko
Ventures). Through Parkwalk, the UK's largest
growth EIS fund manager, we also back world-changing innovation
emerging in leading universities and research
institutions. Our
specialist investment team combines sector expertise with an
international approach. Together we have a strong track record of
success, having backed high-profile companies including Oxford
Nanopore Technologies plc, First Light Fusion, Hysata, and Oxa. IP
Group is listed on the Main Market of the London Stock Exchange
under the code IPO. For more
information, please visit our website at www.ipgroupplc.com.
About Istesso
Istesso is looking at chronic
disease differently, focusing on repairing the damage caused by
debilitating chronic conditions rather than symptom control. We
stand apart, disrupting conventional thinking and seeking robust
science-led treatment solutions to enable patients to live free
from chronic disease. Scientists at heart, with almost 1000 years
of drug discovery expertise, we are the only company to understand
and exploit the body's natural biology of repair. Istesso is
discovering and developing pioneering transformative medicines that
enhance the body's ability to repair, redefine treatment
expectations and make a lasting impact on patients' lives. To learn
more please visit us at: www.istesso.co.uk
About leramistat
Leramistat is an investigational
first-in-class, once-daily pill currently in phase 2 development.
Its unique MOA augments the body's inherent repair response to
repair and restore damaged tissue and build resilience to further
damage without suppressing the immune system.7
Leramistat has been shown to reduce the progression of structural
damage and improve bone dynamics, disability and fatigue in people
with RA.7 With its good safety and tolerability profile
and a low likelihood of interactions with other medicines,
leramistat is ideally positioned as a potential combination therapy
in RA.7
Leramistat offers the potential for
disease resolution across a wide range of therapeutic areas
including chronic diseases of auto-inflammation, autoimmunity,
fibrosis or bone loss.7 Leramistat has been granted both
FDA Fast Track and Orphan Drug Designation (ODD) to support its
development and expedite its review to fill an unmet medical need
in idiopathic pulmonary fibrosis (IPF).
About rheumatoid arthritis
RA is a destructive chronic and
debilitating autoimmune disease causing severe joint and tissue
damage that can lead to disability and premature death affecting
approximately 17.6 million people globally.9,10 This
figure is expected to double to ~31.7 million by 2050 and it is
estimated that ~70% of those affected will be female.12
Bone erosions appear early in the course of RA, often preceding
diagnosis and up to 60% of patients have erosions within a year
leading to joint damage and causing impaired function and
disability.2,4,5 Even with significant treatment
advances, many patients continue to show joint deterioration and
disability, and rates of RA related surgery remain relatively
unchanged in many countries.6,11
The majority of people with RA also
experience daily fatigue with significant overwhelming exhaustion
affecting up to 70% of patients, and almost three quarters
experiencing persistently high or worsening levels of
fatigue.6,12 Fatigue is a key contributor to increased
clinical care costs, primary care consultations and employment
loss, is poorly understood and managed and current treatments have
a minimal effect on fatigue.7,12
About the study
The leramistat phase 2b study was a
12-week randomised, double-blind, placebo-controlled trial of men
and women with moderate-severe RA and an inadequate response to
treatment with methotrexate (MTX). The primary endpoint was
efficacy of leramistat versus placebo as measured by ACR20.
Secondary endpoints included assessment of structural progression
and subclinical inflammation, clinical joint count composite
assessments such as DAS28-CRP, ACR20/50/70 over time, patient
reported outcomes and change in hsCRP.1 The study is
listed on ClinicalTrials.gov and can be accessed here:
https://clinicaltrials.gov/study/NCT05460832.
RA
measures used in the study
ACR208 is a standardised
RA clinical outcome measure developed by the American College of
Rheumatology to evaluate the efficacy of interventions in RA
clinical trials. ACR20 response is defined as at least 20%
improvement from baseline in the number of tender and swollen
joints and in three of the following five criteria: patient's
assessment of pain by visual analogue scale (VAS), patient's global
assessment of disease activity, physician's global assessment of
disease activity, patient's assessment of physical function
measured by HAQ-DI and C-reactive protein (CRP).
1 Data on file - NCT05460832
(IST-06). Listed on NIH National Library of Medicine Clinical
Trials register. Available at:
https://clinicaltrials.gov/study/NCT05460832.
2 Panagopoulos PK et al. Bone erosions in rheumatoid
arthritis: recent developments in pathogenesis and therapeutic
implications. J Musculoskelet
Neuronal Interact. 2018; 18(3):304-319.
3 Schett F et al. Bone erosion in rheumatoid
arthritis: mechanisms, diagnosis and treatment. Nat Rev Rheumatol. 2012;
8(11):6656-664.
4 Kleyer A et al. Bone loss before the clinical
onset of rheumatoid arthritis in subjects with anticitrullinated
protein antibodies. Ann Rheum
Dis. 2014; 73(5):854-60.
5 Pap T et al. Cartilage damage in
osteoarthritis and rheumatoid arthritis--two unequal siblings.
Nat Rev Rheumatol. 2015;
11(10):606-15.
6 Dures E et al. 2023 EULAR recommendations for
the management of fatigue in people with inflammatory rheumatic and
musculoskeletal diseases. Annals
of the Rheumatic Diseases. 2024; 83:1260-1267.
7 Data on file
8 MedwireNews. At a glance: common
scores used in rheumatology. 2018. Available at:
https://www.medwirenews.com/showcase/at-a-glance-common-scores-used-in-rheumatology/
9 Black RJ et al. Global regional, and national
burden of rheumatoid arthritis, 1990-2020, and projections to 2050:
a systematic analysis of the Global Burden of Disease Study 2021.
The Lancet Rheumatology.
2023; 5(10):e594-e610.
10 World Health Organization.
Factsheet: Rheumatoid arthritis; updated 28 June 2023. Available
at:
https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis
11 Tominaga A et al. Surgical intervention for
patients with rheumatoid arthritis is declining except for foot and
ankle surgery: A single-centre, 20-year observational cohort study.
Modern Rheumatology. 2023;
33(3):509-516.
12 Druce KL et al. Predictors of fatigue in
rheumatoid arthritis. Rheumatology. 2019;
58(5):v29-v34.
ENDS
