[Ad hoc announcement pursuant to Art. 53 LR] Roche announces
positive Phase I results of its oral GLP-1 receptor agonist CT-996
for the treatment of people with obesity
- After four weeks of treatment, CT-996 demonstrated
clinically meaningful weight loss of -7.3% (weight loss in placebo
-1.2%; p < 0.001)1
- Pharmacokinetic data supports a once-daily oral dosing
regimen for CT-9961
- The safety and tolerability profile was consistent with
other oral GLP-1 receptor agonists and no unexpected safety signals
were observed1
Basel, 17 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today positive topline results from two arms of an
ongoing multi-part Phase I clinical trial for CT-996, an
investigational, once-daily, oral small molecule GLP-1 receptor
agonist being developed for the treatment of both type 2 diabetes
and obesity.1 The data showed that treatment with CT-996
in participants with obesity and without type 2 diabetes resulted
in a clinically meaningful placebo-adjusted mean weight loss of
-6.1% within four weeks (p <0.001).1 The full study
data will be presented at an upcoming medical meeting.
Obesity is one of the most urgent health challenges in the world
with extensive comorbidities, such as type 2 diabetes,
cardiovascular disease, liver disease, and chronic kidney
disease.2 More than four billion people - about 50% of
the world’s population - are estimated to be impacted by obesity or
will be overweight by 2035.3,4
"We are pleased to see the clinically meaningful weight loss in
people treated with our oral GLP-1 therapy CT-996, which could
eventually help patients address both chronic weight management and
glycaemic control indications,” said Levi Garraway, M.D., Ph.D.,
Roche’s Chief Medical Officer and Head of Global Product
Development. “Following our data for CT-388, this is the second
positive readout in less than three months from our growing
metabolic pipeline, which includes both oral and injectable options
to address patients' needs across a spectrum of related
diseases."
CT-996 was well tolerated, with mostly mild or moderate
gastrointestinal-related adverse events, consistent with the safety
profile of the incretin drug class. There were no treatment
discontinuations related to the study drug.1 The study
results also showed that blood levels of CT-996 were largely
unaffected either during fasting or after a standardised high-fat
meal. Thus, CT-996 could potentially be dosed without regard to
meal timing, thereby affording greater dosing flexibility for
patients.1 Based on the study data, CT-996 is
anticipated to be used not only as a therapy for achieving
glycaemic control and inducing weight loss, but also potentially
for oral weight maintenance therapy following weight loss induced
by injectables.
Despite numerous approved treatments, the trajectory for people
with obesity or its comorbidities has not changed significantly;
these conditions remain underdiagnosed and undertreated so their
impact on society continues to grow.5 Oral and
injectable incretin modalities are critical to address the high
unmet need. They may not only offer broader access to patients
living with obesity, but together, they could also support the
prevention of obesity-related comorbidities or complications such
as type 2 diabetes and heart disease among many others.
About CT-996 study6
The CT-996-201 trial (NCT05814107) is a multi-part, multi-cohort
Phase I randomised, double-blind, placebo-controlled, single- and
multiple- ascending dose study designed to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of CT-996 in
otherwise-healthy adults who are overweight or obese, with and
without type 2 diabetes. Part 1 was a single ascending dose in
40 participants with overweight or obesity (completed);
part 2 was a multiple ascending dose in three sequential cohorts of
a total of 25 participants with obesity without type 2 diabetes
(completed); part 3 is a multiple ascending dose study in two
sequential cohorts of 30 participants with obesity and type 2
diabetes (planned to be initiated in Q4 2024). The primary endpoint
of the trial is safety and tolerability of CT-996; secondary
endpoints include the assessment of the pharmacokinetics of CT-996,
along with its effect on body weight and glucose homeostasis. Based
on the current Phase I results, CT-996 will advance into Phase II
clinical development.
About CT-996
Affecting around 29 million
people globally, diabetic macular edema (DME) is a vision- CT-996
is an investigational, once-daily, oral small molecule GLP-1
receptor agonist being developed for the treatment of both type 2
diabetes and obesity.7 Unlike the endogenous GLP-1
hormone, CT-996 is specifically designed to be a biased GLP-1
receptor agonist that activates cAMP signalling with minimal-to-no
beta-arrestin recruitment. These finely-tuned signalling properties
are expected to lead to strong glycaemic control, significant
weight loss and good tolerability.
About Roche’s metabolism portfolio
Obesity
is a heterogeneous disease and our R&D portfolio of
incretin-based clinical and preclinical assets has great potential
to address patients’ needs by providing treatments as mono and
combination therapy for obesity, diabetes and various other
cardiometabolic indications. We are developing a broad portfolio of
foundational assets that range from orals to injectables, as well
as molecules with new modes of action to address the multiple needs
of patients living with obesity. Our differentiated incretin
portfolio includes:
- CT-388, an investigational dual GLP-1/GIP receptor agonist for
the treatment of obesity in patients with and without type 2
diabetes, currently in Phase II. Injected subcutaneously once a
week, it is being developed both as a standalone and possibly also
in combination, and has the potential to be a best in class therapy
for chronic weight management, type 2 diabetes, and could be
expanded to other indications.8
- CT-996, an investigational, once-daily, oral small molecule
GLP-1 receptor agonist being developed for the treatment of both
type 2 diabetes and obesity, currently in Phase I, with the
potential to be a best-in-class oral treatment for type 2 diabetes
and chronic weight management.6
- CT-868, an investigational, once-daily, subcutaneously
injected dual GLP-1/GIP receptor agonist currently in Phase II with
the potential to be a first in class treatment for glycaemic
control as an adjunct to insulin in patients living with type 1
diabetes.9
Incretins are gut hormones secreted after food intake that play
a role in modulating blood glucose by stimulating insulin secretion
and suppress appetite. Emerging scientific data show a wider
biologic effect of incretins in multiple organs including the
liver, heart and brain, suggesting they may have a broader role in
the body beyond glucose modulation. Over the past few years,
incretins have been clinically validated as targets and are now the
emerging standard of care therapies in obesity, but could also be
effective in other metabolic indications, as well as in
cardiovascular and chronic kidney disease.10
About Roche
Founded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] Roche data on file.
[2] Usman MS, et al. The Interplay Between Diabetes, Cardiovascular
Disease, and Kidney Disease. National Library of Medicine. 2021.
Available from: https://www.ncbi.nlm.nih.gov/books/NBK571718/ doi:
10.2337/db20211-13.
[3] World Health Organization. World Obesity Day 2022 –
Accelerating action to stop obesity. [Internet; cited 2024 July].
Available from:
https://www.who.int/news/item/04-03-2022-world-obesity-day-2022-accelerating-action-to-stop-obesity.
[4] The Lancet. 2024. Worldwide trends in underweight and obesity
from 1990 to 2022: a pooled analysis of 3663
population-representative studies with 222 million children,
adolescents, and adults. 2024;403:10401. Available from:
https://pubmed.ncbi.nlm.nih.gov/38432237/.
[5] Tucker S, et al. The Most Undertreated Chronic Disease:
Addressing Obesity in Primary Care Settings. National Library of
Medicine. 2021. Available from:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8300078/.
[6] ClinicalTrials.gov. A Double-Blind, Randomized,
Placebo-Controlled Phase 1 Study Evaluating the Safety,
Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and
Multiple Doses of CT-996 in Overweight/Obese Participants and in
Patients With Type 2 Diabetes Mellitus [Internet; cited 2024 July].
Available from:
https://clinicaltrials.gov/study/NCT05814107?cond=obesity&term=CT-996%20&checkSpell=&rank=1.
[7] Carmot Therapeutics. Carmot Therapeutics Announces Completion
of Acquisition by Roche [Internet; cited 2024 July]. Available
from:
https://carmot.us/carmot-therapeutics-announces-completion-of-acquisition-by-roche/.
[8] ClinicalTrials.gov. A Phase 1 Randomized, Double Blind, Placebo
Controlled, Study to Evaluate the Safety, Tolerability,
Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise
Healthy Overweight and Obese Adult Participants and in Obese
Patients With Type 2 Diabetes Mellitus [Internet; cited 2024 July].
Available from:
https://clinicaltrials.gov/study/NCT04838405?cond=Obesity&term=CT-388&rank=1.
[9] ClinicalTrials.gov. A Phase 2, Double-Blind, Randomized,
Placebo-Controlled Study to Evaluate the Efficacy, Safety,
Tolerability, and Pharmacokinetics of CT-868 Administered for 16
Weeks to Overweight and Obese Adult Participants With Type 1
Diabetes Mellitus [Internet; cited 2024 July]. Available from:
https://clinicaltrials.gov/study/NCT06062069?cond=Type%201%20Diabetes&term=CT-868&rank=1.
[10] Frontiers. Recent Advances in Incretin-Based Pharmacotherapies
for the Treatment of Obesity and Diabetes [Internet; cited 2024
July]. Available from:
https://www.frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2022.838410/full.
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