GlobeNewswire by notified

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity

Share
  • Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p < 0.001)
  • At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% and 45% achieved >20% weight loss
  • In a subgroup with pre-diabetes at baseline, CT-388 treatment normalised glycemia in all patients, indicating its strong impact on glucose homeostasis
  • No new or unexpected safety signals were detected. Overall, CT-388 demonstrated a safety and tolerability profile consistent with its drug class

Basel, 16 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase I clinical trial of CT-388, a dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes. The study found that a once-weekly subcutaneous injection of CT-388 over 24 weeks resulted in significant weight loss in healthy adults with obesity compared to placebo. The weight loss achieved with CT-388 was clinically meaningful, with a mean placebo-adjusted weight loss of 18.8% (p-value < 0.001). At week 24, 100% of CT-388 treated participants achieved a weight loss of >5%, 85% achieved >10%, 70% achieved >15%, and 45% achieved >20%. The treatment was well tolerated, with mild to moderate gastrointestinal-related adverse events being the most common, consistent with the incretin class of medicines that CT-388 belongs to. All participants with a pre-diabetes status at baseline became normoglycemic after 24 weeks of CT-388 treatment, whereas glycemic status of participants treated with placebo remained largely unchanged during this period.

“We are very pleased to see the significant and clinically meaningful weight loss in people treated with CT-388,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The results are highly encouraging for further development of CT-388 for both obesity and type 2 diabetes and underscore its potential to become a best-in-class therapy with durable weight loss and glucose control.”

Obesity is one of the most urgent health challenges in the world with extensive comorbidities, such as type 2 diabetes, cardiovascular diseases, steatohepatitis and chronic kidney disease. Over four billion people - about 50% of the world’s population - are estimated to be impacted by obesity or being overweight by 2035. The growing number puts an incredible strain on societies and healthcare systems around the world.

CT-388 belongs to the class of incretin-based medicines that aim to regulate blood sugar and reduce appetite. It selectively targets and activates two specific receptors in the body, known as GLP-1 and GIP, which integrate nutrient-derived signals to control food intake, energy absorption and assimilation. It is hypothesised that the dual targeting effect of CT-388 could result in a meaningful durable glucose reduction and weight loss, in addition to a favourable safety profile.

An additional cohort from the ongoing placebo-controlled Phase I trial of CT-388 will evaluate obese patients (BMI>30 kg/m2) with type 2 diabetes over a 12-week treatment duration. Roche expects data from this additional cohort in the second half of 2024.

About the CT-388 study
The CT-388-101 trial is a multi-arm, multi-cohort Phase I randomised, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-388 in otherwise-healthy adult participants with overweight or obesity and in participants with obesity and type-2 diabetes mellitus.

The primary endpoint of the trial is safety and tolerability of CT-388; secondary endpoints include its effect on body weight and glucose homeostasis. Pharmacokinetics and other pharmacodynamic effects of CT-388 were also assessed.

About CT-388
CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes (T2D). CT-388 was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no ß-arrestin recruitment on either receptor. This biased signalling significantly minimises receptor internalisation and consequent desensitisation, which is expected to lead to prolonged pharmacological activity. It is currently being studied in a multi-part, multi-cohort Phase 1 clinical trial in people with overweight/obesity with and without T2D.

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.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
Sileia Urech
Phone: +41 79 935 81 48
Nathalie Altermatt
Phone: +41 79 771 05 25
Simon Goldsborough
Phone: +44 797 32 72 915
Karsten Kleine
Phone: +41 79 461 86 83
Nina Mählitz
Phone: +41 79 327 54 74
Kirti Pandey
Phone: +49 172 6367262
Yvette Petillon
Phone: +41 79 961 92 50
Dr. Rebekka Schnell
Phone: +41 79 205 27 03


Roche Investor Relations

Dr. Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr. Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com

Dr. Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com


Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

The subscription period for the warrants of series TO7 starts today, May 20, 202420.5.2024 08:30:00 CEST | Press release

Today, May 20, 2024, marks the commencement of the exercise period for subscription of warrants of series TO7 in Terranet AB (publ) (”Terranet” or the” Company”). The exercise period for warrants of series TO7 runs up until and including June 3, 2024. Each warrant gives the right to subscribe for one (1) new share of series B in the Company to the price of SEK 0.073 per share. The invested amount must be rounded up to two decimal places. For the warrants not to expire without value, the owner must actively subscribe for new shares no later than June 3, 2024, alternatively sell their warrants no later than May 29, 2024. Please observe that certain nominees might close their application period earlier than June 3, 2024. The letter to holders of warrants of series TO7 is available on the Company's website www.terranet.se. Summarized terms for the warrants of series TO7: Subscription period: May 20, 2024 – June 3, 2024. Issue size: 182,664,660 warrants of series TO7, which entitles to subs

Teckning av aktier med stöd av teckningsoptioner av serie TO7 inleds idag, 20 maj 202420.5.2024 08:30:00 CEST | Pressemelding

Idag, den 20 maj 2024, inleds nyttjandeperioden för teckningsoptioner av serie TO7 i Terranet AB (publ) (”Terranet” eller ”Bolaget”). Nyttjandeperioden pågår till och med den 3 juni 2024. Varje teckningsoption av serie TO7 berättigar innehavaren till teckning av en (1) ny B-aktie i Bolaget till ett pris om 0,073 SEK per aktie. Investerat belopp avrundas uppåt till två decimaler. För att teckningsoptionerna inte ska förfalla utan värde krävs att innehavaren aktivt tecknar aktier senast den 3 juni 2024, alternativt säljer teckningsoptionerna senast den 29 maj 2024. Observera att vissa förvaltare kan stänga anmälningsperioden före den 3 juni 2024. Brev till teckningsoptionsinnehavare av serie TO7 finns att tillgå från Bolagets webbplats på www.terranet.se. Sammanfattade villkor för teckningsoptionerna av serie TO7: Teckningsperiod: 20 maj 2024 – 3 juni 2024. Emissionsvolym: 182 664 660 teckningsoptioner av serie TO7 berättigar till teckning av 182 664 660 B-aktier. Vid fullt nyttjande til

LEADING EDGE MATERIALS APPOINTS KURT BUDGE AS CHIEF EXECUTIVE OFFICER20.5.2024 08:00:00 CEST | Press release

LEADING EDGE MATERIALS APPOINTS KURT BUDGE AS CHIEF EXECUTIVE OFFICER Vancouver, May 19, 2024 – Leading Edge Materials Corp. (“Leading Edge Materials” or the “Company”) (TSXV: LEM) (Nasdaq First North: LEMSE) (OTCQB: LEMIF) (FRA: 7FL) is pleased to announce the appointment of Mr. Kurt Budge as Chief Executive Officer. Chairman Lars-Eric Johansson noted: “The Board is very happy to welcome Kurt to the Company in the role as Chief Executive Officer given his considerable experience leading junior mining companies and especially his knowledge of working in Sweden. The Rare Earth Elements at Norra Kärr makes the project an obvious candidate as a Strategic Project as defined by the EU Critical Raw Materials Act and the Company is focused on applying for this designation. The Exploitation Concession application and environmental work for Norra Kärr are also key priorities. The Company has other Strategic Raw Materials in its portfolio, Natural Graphite at the established mine at Woxna in Swe

Inside Information: Manu Skyttä starts as the President and CEO of Aspocomp Group Plc20.5.2024 08:00:00 CEST | Press release

Aspocomp Group Plc, Inside Information, May 20, 2024, at 9:00 a.m. (Finnish time) Mr. Manu Skyttä, MSc, Aeronautical Engineering, who was appointed as the new President and CEO of Aspocomp Group Plc in February, starts his position today. The Company issued a release on the appointment of Manu Skyttä on February 15, 2024. “We are pleased with the appointment of Mr. Manu Skyttä,” says Ms. Päivi Marttila, Chairman of the Board of Directors. “Manu’s energy and his passion for change and growth, together with his wide experience from different business functions, give him strong competence to develop Aspocomp into the next phase,” adds Päivi Marttila. For further information, please contact Päivi Marttila, Chairman of the Board of Directors, tel. +358 400 285 358. ASPOCOMP GROUP PLC Päivi Marttila Chairman of the Board of Directors www.aspocomp.com Aspocomp – heart of your technology A printed circuit board (PCB) is used for electrical interconnection and as a component assembly platform i

Hexagon Purus and Hino Trucks Introduce Tern: A Pioneering Electric Heavy-Duty Truck20.5.2024 07:00:00 CEST | Press release

Las Vegas, NV, May 20, 2024 – Today at the Advanced Clean Transportation (ACT) Expo, Hexagon Purus in partnership with Hino Trucks, proudly announces the launch of Tern, a dedicated zero-emission truck brand along with their inaugural vehicle model, the RC8, a groundbreaking battery electric Class 8 tractor tailored for the U.S. market. This innovative semi-tractor leverages Hexagon Purus' years of development of zero-emission drivetrains for heavy-duty trucks and represents a driver-preferred option for fleets that are electrifying practical routes. A product of the new long-term agreement between Hexagon Purus and Hino Trucks, valued at up to approximately $2 billion, Tern is designed to deliver a seamless transition to electrification for the U.S. commercial vehicle sector. Manufactured in Hexagon Purus' new facility in Dallas, Texas, the Tern RC8 is scheduled for serial production in late 2024. Built on Hino's proven XL Series 4x2 chassis and equipped with Hexagon Purus' cutting-ed

HiddenA line styled icon from Orion Icon Library.Eye