RCS - IP Group PLC - Microbiotica announces positive P1b trial results

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11/02/2026 09:15

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RNS Number : 4907S  IP Group PLC  11 February 2026

 FOR RELEASE ON  11 February 2026

Portfolio company Microbiotica announces impressive results in its Phase 1b
trial of MB310 in Ulcerative Colitis

 Potential to become a new modality in the treatment of ulcerative colitis
offering prolonged remission without immune suppression

IP Group plc (LSE: IPO) ("IP Group" or "the Group"), which invests in
breakthrough science and technology companies with the potential to create a
better future for all, notes that portfolio company Microbiotica Ltd
("Microbiotica" or "the Company") has announced positive results in its Phase
1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis patients.

Microbiotica, a clinical-stage biopharma company developing a pipeline of oral
precision microbiome medicines called live biotherapeutic products, noted that
MB310 (an investigational oral precision microbiome investigational medicine
taken once daily) met its primary and secondary study objectives being safe
and well tolerated, with successful engraftment of the MB310 bacteria and
statistically significant improvements in efficacy parameters compared with
placebo at the end of study assessments.

Notably, MB310 achieved clinical remission that was indicative of disease
modification. IP Group has an undiluted beneficial holding of 16.7% in
Microbiotica, valued at £13.9m as at 30 June 2025.

The full announcement from the Company follows.

Microbiotica Announces Impressive Results in its Phase 1b Trial of MB310 in
Ulcerative Colitis

Potential to become a new modality in the treatment of ulcerative colitis
offering prolonged remission without immune suppression

            The study which compared MB310, a precision microbiome
medicine, with placebo in 29 ulcerative colitis (UC) patients met its primary
and secondary objectives to demonstrate safety, efficacy and engraftment:

Efficacy:

·      Clinical remission achieved in 63.2% (12/19) MB310 treated
patients vs 30.0% (3/10) in placebo treated patients (ITT analysis)

·      All MB310 treated patients who entered follow-up (n=12) achieved
sustained clinical remission and complete resolution of rectal bleeding

·      MB310 treatment improved objective histological measures of
disease activity with striking improvements in microscopic markers of mucosal
damage

·      MB310 treatment reduced the key bowel inflammation biomarker,
faecal calprotectin

Engraftment: Rapid and robust engraftment of all 8 strains in the MB310
consortium, which was fully maintained throughout the dosing period and
3-month follow-up

Safety: MB310 was well tolerated with a safety profile indistinguishable from
placebo and withdrawal rates similar in both arms

•           If confirmed in larger studies, MB310 has the
potential to transform the management of ulcerative colitis by restoring a
healthy gut barrier thereby changing the natural history of the disease
resulting in long-term clinical remission

•           Next step is to conduct a Phase 2/3 study in UC in
combination with anti-inflammatory and/or immune modulatory induction agents

Cambridge, UK - 11 February 2026: Microbiotica, a clinical-stage biopharma
company developing a pipeline of oral precision microbiome medicines called
live biotherapeutic products (LBPs), announces positive results in its Phase
1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC)
patients.

The study of MB310 (an investigational precision microbiome medicine taken
orally once daily) met its primary and secondary study objectives being safe
and well tolerated, with successful engraftment of the MB310 bacteria and
statistically significant improvements in efficacy parameters compared with
placebo at the end of study assessments. Notably, MB310 achieved clinical
remission that was indicative of disease modification.

Professor Herbert Tilg, Medical University, Innsbruck, Austria and Scientific
Advisory Board member, said, "These early results are encouraging. Ulcerative
colitis is a debilitating inflammatory bowel disease that affects over 1.4
million people globally. By dosing with healthy bacterial species shown to be
associated with clinical improvements in ulcerative colitis, MB310 has the
potential to be a transformative medicine that could be disease modifying and
change the underlying natural pathology of the condition."

Study design

COMPOSER-1 was a randomised, placebo-controlled, double-blind, clinical trial
that recruited 29 adult patients at clinical centres in five countries across
Europe (UK, Austria, Bulgaria, Poland and Spain), with active,
mild-to-moderate UC. The patients took two capsules of study medication
(active or matched placebo) once a day for 12 weeks in addition to their
standard of care medication, with a 12-week follow-up period. (Study
identifiers: NCT06582264; 2023-507376-50).

Study results

The study met its primary objective, demonstrating that MB310 had a similar
safety profile as placebo. The bacterial strains within MB310 successfully
engrafted into patients as early as the first week into treatment. All eight
bacteria of the MB310 consortium persisted throughout the 3-month treatment
period and were also maintained during the 3-month post dosing follow-up
period. This indicates patients had full exposure to MB310 for the entire
study, including both dosing and 3-month follow-up period.

Initial signals of efficacy were measured using standard clinical endpoints,
including assessment of clinical signs and symptoms, endoscopy, histology and
inflammatory biomarkers. MB310 demonstrated:

•           Improvement in remission for patients on MB310 (12 out
of 19, i.e., 63%) compared with those on placebo (3 out of 10, i.e., 30%) as
measured by partial Mayo score (the standard disease activity index)

•           All 12 patients who completed MB310 treatment and
entered the follow-up stage were in clinical remission at the end of study.
Notably rectal bleeding, a symptom known to be of importance in UC, was
completely resolved

•           Improvement of histological markers of disease
activity, and particularly those relating to gut epithelial barrier integrity
compared to baseline and placebo

•           Improvement of the key biomarker of active bowel
inflammation, faecal calprotectin, consistent with the observed improvement in
clinical signs and symptoms compared to placebo

•           Withdrawal rates similar in both arms

These data are supportive of preclinical studies that have demonstrated that
the MB310 consortium acts via at least three independent mechanisms that are
central to the pathology of UC: promoting the healing of the damaged gut
epithelial barrier; regulating the balance of cytokines that are inflammatory
(TNF) and immune-modulatory (IL-10); and inducing a regulatory T-cell
response.

Dr Robert Tansley, Microbiotica's Chief Medical Officer, said, "We are
encouraged by these positive data from our Phase 1b study of MB310 in
ulcerative colitis. Our clinic-led approach to the discovery of live
biotherapeutic products results in a defined, consistent and reproducible
product, which we believe has the best chance of producing clinical benefit by
becoming safely established in the microbiome of patients and addressing key
underlying causes of ulcerative colitis.

"Our first-in-human study has demonstrated safety and tolerability together
with encouraging efficacy data. It supports the hypothesis that MB310 has the
potential to deliver disease modifying, long lasting remission with an
excellent tolerability profile.

"The highly encouraging clinical remission rates at 6 months, is more
impressive than any ulcerative colitis therapy I have seen to date. If
confirmed in larger studies, MB310 has the potential to transform the
management of ulcerative colitis by addressing a key factor behind the
pathophysiology of the disease not currently treated. We are planning our
Phase 2/3 studies where such potential is evaluated in combination with
standard of care therapies."

Tim Sharpington, CEO of Microbiotica, added, "We are very excited about these
promising results. MB310 has the potential to be a new, differentiated
treatment modality for patients with ulcerative colitis, offering the hope of
long-lasting disease remission without side effects.

"The study results also provide validation of our clinic-first microbiome
discovery platform which brings new precision in the identification of
bacterial strains associated positive outcomes from clinical trial data.
Combined with our increased understanding of the mechanisms by which our
microbiome interact with host cells, this gives us the opportunity to design
differentiated, precision microbiome medicines in different disease settings.

"During 2026, we will explore partnering and financing options to determine
the best route to fund our products through later studies and towards
commercialisation."

Future plans

Microbiotica is conducting additional analysis of COMPOSER-1 data, to further
explore the impact of MB310 and to inform the design of the adaptive Phase 2/3
study. It is anticipated that this study will explore the disease modifying
'slower-onset longer-acting' potential of MB310 in combination with
anti-inflammatory and/or immuno-modulatory induction agents.

- ENDS -

About Ulcerative Colitis - MB310 and the COMPOSER-1 study

Ulcerative colitis, an inflammatory bowel disease, is a debilitating disease
that affects over 1.4 million people globally. The gut microbiome is now
understood to contribute significantly to the disease pathology but is not
targeted by current therapies. The rapid increase in incidence and prevalence
of UC in Europe and North America in the 20th century as well as the ongoing
increase in newly industrialised countries is believed to be associated with
detrimental changes to the microbiome resulting from increased processed
foods, changing diet, increased use of antibiotics and improved hygiene.

MB310, an investigational microbiome medicine, has been developed as an oral
capsule, dosed once daily, containing a defined consortium of eight live gut
commensal bacterial strains. It is designed to deliver long-term remission to
UC patients, without immunosuppression or unwanted side-effects. The bacterial
strains in MB310 were identified by analysing clinical and microbiome data
from a faecal microbiota transplant (FMT) study in UC patients carried out
with collaborators at the University of Adelaide. The results demonstrated the
ability of a microbiome therapy to induce remission in UC with an excellent
tolerability profile. Microbiotica's analysis identified the engrafting
bacteria associated with clinical response, leading to the development of
MB310 as an LBP.

The COMPOSER-1, first-in-human study investigated the safety, tolerability,
and initial signals of efficacy of MB310 in a randomised, placebo-controlled,
double-blind, clinical trial. The degree to which the bacteria within MB310
successfully engraft into patients' intestinal microbial community was
measured. The study enrolled 29 patients with active, mild-to-moderate UC, who
took two capsules of study medication (active or matched placebo) once a day
for 12 weeks in addition to their standard of care medication, with a 12-week
follow-up period. (Study identifiers: NCT06582264; 2023-507376-50). Positive
data readout reported in early 2026 demonstrated that MB310 met primary and
secondary study objectives being safe and well tolerated, with successful
engraftment of the MB310 bacteria and statistically significant improvements
in efficacy parameters. The study achieved clinical remission indicative of
disease modification.

About Microbiotica

Microbiotica is a private, clinical-stage, biopharma Company developing a
pipeline of oral precision microbiome medicines called live biotherapeutic
products (LBPs) with lead programmes in immuno-oncology and inflammatory bowel
disease. The Company has a clinic-led, purpose-built, proprietary, microbiome
profiling platform to support drug discovery based on clinical data, which
enables precision identification of bacteria associated with favourable
clinical trial outcomes in specific patient populations. The Company has
significant expertise in microbiology, bioinformatics, translational biology
and LBP manufacturing and development.

The Company is creating a novel pipeline of programmes in immuno-oncology
(MB097 for advanced melanoma), and inflammatory bowel disease (MB310 for
ulcerative colitis). It has a major partnership with Cancer Research UK and
Cambridge University Hospitals in immuno-oncology. The Company has a clinical
trial supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) for
use of KEYTRUDA in evaluating MB097 in melanoma patients with primary
resistance to anti-PD-1 immunotherapy. MB310 was developed in collaboration
with the University of Adelaide.

Spun out of the Wellcome Sanger Institute in 2016, the Company is based in
purpose-built facilities at the Chesterford Research Park near Cambridge, UK.
Microbiotica has raised more than £62 million equity investment, including a
£50 million Series B in 2022, with venture investors including British
Patient Capital, Cambridge Innovation Capital, Flerie Invest, IP Group plc,
Seventure Partners and Tencent. The Company has also received financial
support from the US-based Crohn's and Colitis Foundation.

 

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
 Lewis Bendall-Craft                +44 (0) 7931 973950

 

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 and technology investor, we develop and
support some of the world's most exciting businesses in healthtech, deeptech
and cleantech. 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, Hinge Health, 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

 

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