REG - IP Group PLC - Istesso data demonstrate tissue repair

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RNS Number : 3719R  IP Group PLC  17 July 2025

 FOR RELEASE ON  17 July 2025

 

  Ground-breaking data demonstrate tissue repair with portfolio company,
Istesso's novel investigational medicines.

Dr Mike Owen now appointed to Istesso's Board of Directors

 

IP Group plc (LSE: IPO) announces that its portfolio company Istesso Ltd
("Istesso") has today published ground-breaking data in the peer reviewed
monthly, The Journal of Pharmacology and Experimental Therapeutics (JPET),
demonstrating its new class of investigational medicines elicit tissue repair
in fibrotic, autoinflammatory and autoimmune conditions - the first oral
agents to demonstrate such activity.

These findings have significant implications for the management of chronic
diseases where tissue damage occurs, including chronic diseases such as
rheumatoid arthritis, degenerative conditions of ageing such as osteoporosis,
sarcopenia (muscle loss) and fibrosis (tissue scarring), and could herald a
new era of treatments to minimise the impact of these conditions on people's
lives.

Dr Lisa Patel, lead study author and Istesso's CEO, said: "These findings
could redefine how we think about treating chronic diseases. Eliciting tissue
repair has long been a goal of medicine. This is the first time adaptive
tissue repair has been demonstrated with oral agents in these settings. We are
very excited to be pioneering this game-changing new field, offering a novel
path to stopping, or even reversing, progressive tissue decline."

The announcement from Istesso follows below. Further results from Istesso's
research programme will be presented at relevant congresses and published in
peer review journals in due course.

Separately, Istesso also recently announced the appointment of Dr Mike Owen to
its Board of Directors as a non-executive director with immediate effect. Dr
Owen brings over 40 years' experience in the pharmaceutical and biotechnology
industries and has extensive expertise leading drug discovery and development,
in particular identifying the clinical and commercial positioning of novel
drugs. Dr Owen started his industry career at GSK, where he was Senior Vice
President (SVP) and Head of Biopharmaceuticals Research from 2001 to 2009.
During this time, he was accountable for a biopharmaceuticals portfolio
comprising over twenty projects in multiple therapeutic areas, including
clinical Phase 1 and 2 assets in diseases of major unmet medical need such as
cancer, Alzheimer's, motor neurone disease, severe asthma and rheumatoid
arthritis.

Dr Owen said: "I'm very happy to be joining Istesso at this important time. I
have been following Istesso's bold approach to reversing tissue damage with
great interest. Its promising scientific research into this currently untapped
area has the potential to fundamentally change the treatment paradigm for
chronic diseases and therefore holds enormous clinical and commercial
potential. I can't wait to get started in helping Istesso accelerate the
development of its investigational lead drug leramistat."

IP Group has an undiluted holding of 56.5% in Istesso.

 

For more information, please contact:

 

 IP Group plc                       www.ipgroupplc.com
 Liz Vaughan-Adams, Communications  +44 (0) 20 7444 0062/+44 (0) 7967 312125
 Portland
 Alex Donaldson                     +44 (0) 7516 729702

 

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, Featurespace, 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 (http://www.ipgroupplc.com/) .

 

ENDS

 

Ground-breaking data demonstrates tissue repair with Istesso's novel
investigational medicines

·    Istesso's new class of developmental drugs, which inhibit
mitochondrial complex I, are the first to elicit tissue repair in fibrotic,
autoinflammatory and autoimmune conditions.(1,2)

·    The unique mechanism of action (MOA) means these drugs also have the
potential to slow progressive age-related decline and build resilience against
the accumulation of age-related tissue damage, helping us to age better and
live longer.(1)(,3, 4)

·    These findings have significant implications for the management of
chronic diseases where tissue damage occurs, including chronic autoimmune
diseases such as rheumatoid arthritis (RA), degenerative conditions of ageing
such as osteoporosis, sarcopenia (muscle loss) and fibrosis (tissue scarring),
and could herald a new era of treatments to minimise the impact of these
conditions on people's lives.(1)(,)(2)(, 5, 6)

London, UK, 16(th) July 2025. Published today in peer reviewed monthly, The
Journal of Pharmacology and Experimental Therapeutics (JPET), Istesso, the
adaptive tissue-repair company, reveals data showing that its novel,
first-in-class mitochondrial Complex I inhibitors elicit tissue repair in
models of autoimmune and fibrotic disease.(1) Istesso's novel approach works
in a completely new way; by modulating mitochondria - the beating heart of the
body's cells - to support the body's repair systems.(1) In doing so, it
enhances tissue repair, augments the body's natural ability to mobilise
progenitor cells,(1) a type of stem cell which repair injuries and regenerate
tissue, and reduces tissue damage and inflammation in models of arthritis and
lung scarring.(1)(,)(2)

"These findings could redefine how we think about treating chronic diseases,"
said Dr Lisa Patel, lead study author and Istesso's CEO. "Eliciting tissue
repair has long been a goal of medicine. This is the first time adaptive
tissue repair has been demonstrated with oral agents in these settings. We are
very excited to be pioneering this game-changing new field, offering a novel
path to stopping, or even reversing, progressive tissue decline."

Tissue damage occurs in nearly every human illness and is a universal feature
of ageing.7(,8) Accumulating tissue damage also predisposes to chronic
disease, which is the leading cause of illness, disability and premature death
globally.(5)(,)(6) Whilst traditional medicines such as anti-inflammatory
drugs used to treat conditions like RA and inflammatory bowel disease (IBD)
are effective in treating symptoms, they do not support, and may suppress, the
body's natural repair processes.9(,10) The novel biological effects seen with
Istesso's pipeline of treatments could offer the potential to directly prevent
or even potentially reverse progressive tissue decline in multiple chronic
diseases such as RA or IPF, or in degenerative conditions such as muscle or
bone loss (sarcopenia and osteoporosis).(11, 12, 13,14, 15)

"This work opens a new chapter in mitochondrial pharmacology" commented
Professor Sir Keith Peters, Regius Professor of Physic Emeritus, and
Non-executive Board Director, Istesso.

Early findings suggest that this biology may be replicated in the clinic.
Istesso's lead investigational medicine, leramistat has consistently
demonstrated its effectiveness in preventing tissue
deterioration.(1)(,)(2)(,16) In Phase 2 clinical studies (yet to be
published), RA patients given leramistat showed significantly improved bone
erosions, disability and fatigue responses, as well as improvements in markers
of inflammaging (chronic inflammation associated with ageing) such as
C-Reactive Protein (CRP), and of changes in mitochondrial function such as
Growth Differentiation Factor 15 (GDF15) and Fibroblast Growth Factor 21
(FGF21).(2) Treatment with leramistat also improved the balance between bone
formation and loss which is disrupted in RA.(2) This encouraging profile has
been accompanied by good toleration and a benign adverse event (AE) profile
with no serious AEs attributed to treatment in any studies to date.(2)

Further results from our research programme will be presented at relevant
congresses and published in peer review journals in due course.

- Ends -

Notes to editors

JPET publication

The Journal of Pharmacology and Experimental Therapeutics (JPET), is the
official journal of the American Society for Pharmacology and Experimental
Therapeutics and the full publication can be accessed here:
https://doi.org/10.1016/j.jpet.2025.103661
(https://doi.org/10.1016/j.jpet.2025.103661)

About mitochondria

Mitochondria, often referred to as the powerhouses of the cell, are present in
nearly all types of human cell and are vital to our survival. They perform
many different functions including generating energy to power cells,
regulating metabolism and playing a key role in cell responses to infection
and injury and signalling between cells and tissues. Damage or disruption to
mitochondrial signalling underlies many human diseases ranging from genetic
disorders that affect how mitochondria are made, to age-related degenerative
disorders such as sarcopenia, osteoporosis, and Alzheimer's disease,
autoimmune diseases such as RA and IBD, and fibrotic diseases such as IPF or
heart failure.(17,18,19) When mitochondria experience a change in their
function, they release proteins such as GDF15 or FGF21 which signal the change
into their environment.(20)

About tissue repair

In health and throughout life, our bodies maintain a natural equilibrium,
constantly renewing cells and tissues in the body and balancing any damage
that occurs with a natural capacity to repair.(7)  As we age, this process
deteriorates putting us at increased risk of chronic diseases which in turn
contribute to further progressive tissue damage and reduce the body's natural
capacity to repair.(4)(,)(5)(,)(7) This has led to the hypothesis that
longevity may result from the ability to sustain this tissue renewal
process.(10)(,)(20) Current treatment approaches and research focus on symptom
control, usually by suppressing uncontrolled inflammation or fibrosis (tissue
scarring) but do not support the body's natural repair process.(6)(,)(9) As a
consequence, disease-related damage persists and progresses, albeit at a
slower rate than without treatment, and in some cases may drive further
symptoms.(21, 22, 23)

Identifying a signal that can direct damaged tissues to regenerate and repair
is a critical goal of medicine which has remained elusive until now.(3)
Istesso's investigational treatments work in a completely new way, turning on
the body's 'repair switch' to enable the repair of damaged tissue and restore
tissue architecture to its original form.(1)(,)(2) This approach, leveraging
and enhancing the body's natural repair system, potentially offers powerful
new tools, with a good safety profile, to support tissue repair and ultimately
resolve disease, and extend human healthspan.(4)

About rheumatoid arthritis (RA)

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.(24, 25) This figure is
expected to double to ~31.7 million by 2050 and it is estimated that ~70% of
those affected will be female.(24) 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.(26,
27, 28) 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.(29, 30)

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.(30, 31) Fatigue is a key contributor to increased clinical care
costs, primary care consultations and employment loss, and is poorly
understood and managed. Current treatments have a minimal effect on
fatigue.(24)

About leramistat

Leramistat is an investigational first-in-class, once-daily pill currently in
phase 2 development where it is being evaluated for its potential to elicit
musculoskeletal repair in secondary sarcopenia. It is a novel inhibitor of
mitochondrial Complex I, and its unique MOA augments the body's inherent
capacity to repair, restoring damaged tissue and building resilience without
suppressing the immune system.(1)(,)(2) Leramistat has been shown to reduce
the progression of structural damage, improve disability and fatigue and
improve inflammaging (CRP) in people with RA, where it offers the potential to
target aspects of the condition that remain unmet by current therapies.(2)

Leramistat offers the potential for disease resolution across a wide range of
therapeutic areas including primary and secondary sarcopenia, bone and
metabolic disorders, and chronic diseases of auto-inflammation, autoimmunity
and fibrosis.(1)(,)(2) 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 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 (http://www.istesso.co.uk)

For more information, please contact

Istesso media relations:

Email: stuart@lolly-agency.co.uk

Tel: 01935 816 400

References

1.     Patel L et al. Phenotypic Pharmacology of Novel Complex I
Inhibitors Eliciting Tissue Repair Concurrent to Control of Inflammation.
JPET. 2025; https://doi.org/10.1016/j.jpet.2025.103661
(https://doi.org/10.1016/j.jpet.2025.103661)

2.     Data on file

3.     Mikawa T et al.  Senotherapy preserves resilience in aging.
Geriatr. Gerontol. Int. 2024; 24:845-849.

4.     Ukraintseva S et al.  Decline in biological resilience as key
manifestation of aging: Potential mechanisms and role in health and
longevity.  Mechanisms of Ageing and Development.  2021; 194:111418

5.     Martin P et al. Imperfect wound healing sets the stage for chronic
diseases. Science. 2024; 386,eadp2974

6.     World Health Organization.  Factsheet: Noncommunicable diseases.
September 2023.  Available at:
https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases
(https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases)
.   Last accessed April 2025.

7.     Cai Y et al. Decoding aging-dependent regenerative decline across
tissues at single-cell resolution. Cell Stem Cell 2023; 30(12); 1674

8.     Abila E et al. Tissue clocks derived from histological signatures
of biological aging enable tissue-specific aging predictions from blood.
bioRXIV 2024; 11.14.618081

9.     Bootun R, Effects of immunosuppressive therapy on wound healing.
Int Wound J. 2013; 10(1):98-104.

10.  Fischer, R, Selective Targeting of TNF Receptors as a Novel Therapeutic
Approach. Frontiers in Cell and Developmental Biology. 2020; 8:401

11.   van der Spoel E, Viewpoint on the role of tissue maintenance in
ageing: focus on biomarkers of bone, cartilage, muscle, and brain tissue
maintenance, Ageing Research Reviews, 56,2019,100964

12.  Ringe J, Regenerative medicine in rheumatic disease-progress in tissue
engineering. Nat Rev Rheumatol. 2012; 8(8):493-8.

13.  Lehmann M, Regenerative Medicine and the Hope for a Cure. Clin Chest
Med. 2021; 42(2):365

14.  Najm A, Emerging Therapeutic Strategies in Sarcopenia: An Updated Review
on Pathogenesis and Treatment Advances. International Journal of Molecular
Sciences. 2024; 25(8):4300

15.  Arjmand B, Prospect of Stem Cell Therapy and Regenerative Medicine in
Osteoporosis. Front Endocrinol (Lausanne). 2020; 3;11:430

16.  Patel L,  et al. OP0234  MBS2320, A novel selective modulator of
immune metabolism, in patients with severe rheumatoid arthritis: safety,
tolerability and efficacy results of a phase 2 study. Annals of the Rheumatic
Diseases. 2020; 79

17.  Pei, L et al., Mitochondria in skeletal system-related diseases.
Biomedicine & Pharmacotherapy, 2024;181:117505

18.  University of Cambridge.  MRC Mitochondrial Biology Unit.  What are
Mitochondria.  Available at:
https://www.mrc-mbu.cam.ac.uk/what-are-mitochondria/mitochondria-disease
(https://www.mrc-mbu.cam.ac.uk/what-are-mitochondria/mitochondria-disease) .
Last accessed April 2025.

19.  Li X et al., Mitochondrial dysfunction in fibrotic diseases. Cell Death
Discov. 2020; 6:80

20.  Jena J. The roles of FGF21 and GDF15 in mediating the mitochondrial
integrated stress response. Front Endocrinol (Lausanne). 2023; 14:1264530

21.  Ruyssen-Witrand, A  et al. Ten-year radiographic and functional
outcomes in rheumatoid arthritis patients in remission compared to patients in
low disease activity. Arthritis Res Ther. 2023; 25:207

22.  Pharmaphorum IPF: Could we reverse the progression?
https://pharmaphorum.com/rd/ipf-could-we-reverse-progression Last accessed
June 2025
(https://pharmaphorum.com/rd/ipf-could-we-reverse-progression%20Last%20accessed%20June%202025)

23.  Ahmad, HA et al. Prediction of flare following remission and treatment
withdrawal in early rheumatoid arthritis: post hoc analysis of a phase IIIb
trial with abatacept. Arthritis Res Ther 2022; 24; 47

24.  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.

25.  World Health Organization. Factsheet: Rheumatoid arthritis; updated 28
June 2023.  Available at:
https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis
(https://www.who.int/news-room/fact-sheets/detail/rheumatoid-arthritis)
Last accessed April 2025.

26.  Panagopoulos PK et al.  Bone erosions in rheumatoid arthritis: recent
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Neuronal Interact. 2018; 18(3):304-319

27.  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.

28.  Pap T et al. Cartilage damage in osteoarthritis and rheumatoid
arthritis--two unequal siblings.  Nat Rev Rheumatol. 2015; 11(10):606-15.

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20-year observational cohort study. Modern Rheumatology.  2023;
33(3):509-516.

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fatigue in people with inflammatory rheumatic and musculoskeletal diseases.
Annals of the Rheumatic Diseases. 2024; 83:1260-1267

31.  Druce KL et al. Predictors of fatigue in rheumatoid arthritis.
Rheumatology. 2019; 58(5):v29-v34.

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