ZEAL announce phase II trial showed 14.9% weight Loss
112541 Helge Larsen/PI-redaktør 10/5 2023 08:35
Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight
10.5.2023 08.30 • GlobeNewswire •
Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight
* Phase II dose-finding trial met primary endpoint after 46 weeks of treatment, representing an important advancement of Boehringer Ingelheim's cardio-renal-metabolic focus areas
* Full data will be presented at the 2023 American Diabetes Association's 83rd Scientific Sessions
* Novel dual glucagon/GLP-1 receptor agonist BI 456906 is part of the collaboration between Boehringer Ingelheim and Zealand Pharma
Ingelheim, Germany, and Copenhagen, Denmark, 10 May, 2023 - Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose. The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint. These results including an analysis of the actual maintenance dose indicating even greater weight loss will be presented at the 2023 American Diabetes Association's 83rd Scientific Sessions in San Diego, CA, U.S. Until then, the data is under embargo.
"Obesity is one of many cardio-renal-metabolic diseases, which together represent one of the fastest growing health challenges worldwide. The distinct mode of action of BI 456906 targets multiple pathways pivotal to metabolic regulation, including those associated with obesity and liver diseases," said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. "With our longstanding heritage in cardio-renal-metabolic diseases, we are excited by the findings and potential implications for millions of people who urgently need healthcare solutions."
"We are both enthusiastic about these data and encouraged by the clinical outcomes announced today," said David Kendall, M.D., Chief Medical Officer, Zealand Pharma. "At Zealand Pharma we continue our long-term commitment to the discovery and development of novel differentiated peptide therapeutics that target critical metabolic pathways to achieve substantial weight loss while addressing the complex pathophysiology of overweight and obesity."
In 2016, more than 1 billion people worldwide were living with cardio-renal-metabolic (CRM) diseases such as obesity, type 2 diabetes, chronic kidney disease, liver disease, heart failure and cardiovascular disease1-10. Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades11. The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with obesity or overweight, placing a high burden on individuals, healthcare systems and society11.
Notes to editors
About the study
This is a Phase II, randomized, parallel group, dose-finding study of subcutaneously administered BI 456906 for 46 weeks compared to placebo in people living with overweight or obesity. The trial included 20 weeks of dosing escalation and 26 weeks maintenance.
About BI 456906
The glucagon/GLP-1 receptor dual agonist activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new treatment that may offer clinically relevant benefit. It is part of Boehringer Ingelheim's research and development portfolio in the cardio-renal-metabolic disease areas.
BI 456906 was co-invented by Boehringer Ingelheim and Zealand Pharma and is currently also being evaluated in a phase II study in adults with NASH and liver fibrosis (stages F1/F2/F3). The trial is expected to complete in Q4 2023. It has received U.S. FDA Fast Track Designation for adults with non-alcoholic steatohepatitis (NASH).
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com
Boehringer Ingelheim's Intended Audiences Notice
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.
Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. that includes Boston. For more information about Zealand's business and activities, please visit www.zealandpharma.com.
Forward-Looking Statement
The above information contains forward-looking statements that provide Zealand Pharma's expectations or forecasts of future events. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. All such forward-looking statements speak only as of the date of this release and are based on information available to Zealand Pharma as of the date of this release.
Media Contacts
Harro ten Wolde
Global Head of Media Relations
Boehringer Ingelheim
Email: harro.ten_wolde@boehringer-ingelheim.com
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
1. Jager KJ, et al. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int 2019;96:1048-1050.
2. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017;390:1211-1259.
3. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet 2020;396:1204-1222.
4. World Health Organization. Obesity and Overweight. 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Last accessed: January 2023.
5. Alicic RZ, Rooney MT, & Tuttle KR. Diabetic kidney disease: Challenges, progress, and possibilities. Clin J Am Soc Nephrol 2017;12:2032-2045.
6. Roth GA, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019: Update from the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
7. Shetty A & Syn WK. Health and economic burden of nonalcoholic fatty liver disease in the United States and its impact on veterans. Fed Pract 2019;36:14-19.
8. Mantovani A, et al. Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism 2020;111S:154170.
9. Sidney S, et al. Recent trends in cardiovascular mortality in the United States and public health goals. JAMA Cardiol 2016;1:594-599.
10. World Obesity Federation. Prevalence of Obesity. 2016. Available at: https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. Last accessed: January 2023.
11. World Obesity Federation. Prevalence of Obesity. 2016. Available at: https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. Last accessed: January 2023.
https://www.globenewswire.com/NewsRoom/ReleaseNg/401540537
10.5.2023 08.30 • GlobeNewswire •
Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight
* Phase II dose-finding trial met primary endpoint after 46 weeks of treatment, representing an important advancement of Boehringer Ingelheim's cardio-renal-metabolic focus areas
* Full data will be presented at the 2023 American Diabetes Association's 83rd Scientific Sessions
* Novel dual glucagon/GLP-1 receptor agonist BI 456906 is part of the collaboration between Boehringer Ingelheim and Zealand Pharma
Ingelheim, Germany, and Copenhagen, Denmark, 10 May, 2023 - Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) today announced that patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose. The phase II clinical trial evaluating the effect of different doses of the novel glucagon/GLP-1 receptor dual agonist BI 456906 in people living with obesity or overweight without type 2 diabetes (NCT04667377) met its primary endpoint. These results including an analysis of the actual maintenance dose indicating even greater weight loss will be presented at the 2023 American Diabetes Association's 83rd Scientific Sessions in San Diego, CA, U.S. Until then, the data is under embargo.
"Obesity is one of many cardio-renal-metabolic diseases, which together represent one of the fastest growing health challenges worldwide. The distinct mode of action of BI 456906 targets multiple pathways pivotal to metabolic regulation, including those associated with obesity and liver diseases," said Carinne Brouillon, Head of Human Pharma, Boehringer Ingelheim. "With our longstanding heritage in cardio-renal-metabolic diseases, we are excited by the findings and potential implications for millions of people who urgently need healthcare solutions."
"We are both enthusiastic about these data and encouraged by the clinical outcomes announced today," said David Kendall, M.D., Chief Medical Officer, Zealand Pharma. "At Zealand Pharma we continue our long-term commitment to the discovery and development of novel differentiated peptide therapeutics that target critical metabolic pathways to achieve substantial weight loss while addressing the complex pathophysiology of overweight and obesity."
In 2016, more than 1 billion people worldwide were living with cardio-renal-metabolic (CRM) diseases such as obesity, type 2 diabetes, chronic kidney disease, liver disease, heart failure and cardiovascular disease1-10. Obesity is a major global health challenge, and the worldwide prevalence has more than doubled over the past four decades11. The World Obesity Federation predicts that by 2025, 2.7 billion adults could be living with obesity or overweight, placing a high burden on individuals, healthcare systems and society11.
Notes to editors
About the study
This is a Phase II, randomized, parallel group, dose-finding study of subcutaneously administered BI 456906 for 46 weeks compared to placebo in people living with overweight or obesity. The trial included 20 weeks of dosing escalation and 26 weeks maintenance.
About BI 456906
The glucagon/GLP-1 receptor dual agonist activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new treatment that may offer clinically relevant benefit. It is part of Boehringer Ingelheim's research and development portfolio in the cardio-renal-metabolic disease areas.
BI 456906 was co-invented by Boehringer Ingelheim and Zealand Pharma and is currently also being evaluated in a phase II study in adults with NASH and liver fibrosis (stages F1/F2/F3). The trial is expected to complete in Q4 2023. It has received U.S. FDA Fast Track Designation for adults with non-alcoholic steatohepatitis (NASH).
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units, Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com
Boehringer Ingelheim's Intended Audiences Notice
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.
Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. that includes Boston. For more information about Zealand's business and activities, please visit www.zealandpharma.com.
Forward-Looking Statement
The above information contains forward-looking statements that provide Zealand Pharma's expectations or forecasts of future events. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. All such forward-looking statements speak only as of the date of this release and are based on information available to Zealand Pharma as of the date of this release.
Media Contacts
Harro ten Wolde
Global Head of Media Relations
Boehringer Ingelheim
Email: harro.ten_wolde@boehringer-ingelheim.com
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
1. Jager KJ, et al. A single number for advocacy and communication-worldwide more than 850 million individuals have kidney diseases. Kidney Int 2019;96:1048-1050.
2. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. Lancet 2017;390:1211-1259.
3. GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: A systematic analysis for the Global Burden of Disease Study 2019. Lancet 2020;396:1204-1222.
4. World Health Organization. Obesity and Overweight. 2021. Available at: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Last accessed: January 2023.
5. Alicic RZ, Rooney MT, & Tuttle KR. Diabetic kidney disease: Challenges, progress, and possibilities. Clin J Am Soc Nephrol 2017;12:2032-2045.
6. Roth GA, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019: Update from the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
7. Shetty A & Syn WK. Health and economic burden of nonalcoholic fatty liver disease in the United States and its impact on veterans. Fed Pract 2019;36:14-19.
8. Mantovani A, et al. Complications, morbidity and mortality of nonalcoholic fatty liver disease. Metabolism 2020;111S:154170.
9. Sidney S, et al. Recent trends in cardiovascular mortality in the United States and public health goals. JAMA Cardiol 2016;1:594-599.
10. World Obesity Federation. Prevalence of Obesity. 2016. Available at: https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. Last accessed: January 2023.
11. World Obesity Federation. Prevalence of Obesity. 2016. Available at: https://www.worldobesity.org/about/about-obesity/prevalence-of-obesity. Last accessed: January 2023.
https://www.globenewswire.com/NewsRoom/ReleaseNg/401540537
10/5 2023 11:24 ProInvestorNEWS 7
112544 Zealand Pharma fremviser vægttab på op mod 14,9 pct. i fase 2-studie
10/5 10:09
Zealand Pharma har i samarbejde med tyske Boehringer Ingelheim demonstreret vægttab på op mod 14,9 pct. hos svært overvægtige og overvægtige personer uden type 2-diabetes.
Dermed er det primære endemål for studiet med lægemiddelkandidaten BI 456906 opnået efter behandling over 46 uger.
Det fremgår af data fra en fase 2-undersøgelse, som Zealand Pharma har offentliggjort onsdag morgen.
De endelige data fra fase 2-studiet vil blive offentliggjort ved en medicinalkonference i USA senere på året.
Fase 2-studiet blev afsluttet i oktober 2022, fremgår det af databasen Clinical Trials ifølge Medwatch.
Lægemiddelkandidaten BI 456906 blev indlicenseret tilbage i 2011 af Zealand Pharma. Det er en kombination af en GLP-1-analog og en analog af sukkerhormonet glukagon.
Tyske Boehringer Ingelheim står i dag for finansieringen i forhold til forskning, udvikling og eventuel kommercialisering af kandidaten. Til gengæld kan Zealand Pharma se frem til at modtage op mod 345 mio. euro i milepælsbetalinger samt royalties ved et eventuelt globalt salg af lægemiddelkandidaten, skriver Medwatch.
Aktien i Zealand Pharma stiger onsdag 0,3 pct. til 224,80 kr. på børsen i København.
.\˙ MarketWire
10/5 10:09
Zealand Pharma har i samarbejde med tyske Boehringer Ingelheim demonstreret vægttab på op mod 14,9 pct. hos svært overvægtige og overvægtige personer uden type 2-diabetes.
Dermed er det primære endemål for studiet med lægemiddelkandidaten BI 456906 opnået efter behandling over 46 uger.
Det fremgår af data fra en fase 2-undersøgelse, som Zealand Pharma har offentliggjort onsdag morgen.
De endelige data fra fase 2-studiet vil blive offentliggjort ved en medicinalkonference i USA senere på året.
Fase 2-studiet blev afsluttet i oktober 2022, fremgår det af databasen Clinical Trials ifølge Medwatch.
Lægemiddelkandidaten BI 456906 blev indlicenseret tilbage i 2011 af Zealand Pharma. Det er en kombination af en GLP-1-analog og en analog af sukkerhormonet glukagon.
Tyske Boehringer Ingelheim står i dag for finansieringen i forhold til forskning, udvikling og eventuel kommercialisering af kandidaten. Til gengæld kan Zealand Pharma se frem til at modtage op mod 345 mio. euro i milepælsbetalinger samt royalties ved et eventuelt globalt salg af lægemiddelkandidaten, skriver Medwatch.
Aktien i Zealand Pharma stiger onsdag 0,3 pct. til 224,80 kr. på børsen i København.
.\˙ MarketWire
10/5 2023 14:41 ProInvestorNEWS 7112548 Zealand/Sydbank: Lovende fedmedata kan give plads på attraktivt marked
10/5 13:49
Zealand Pharma har onsdag præsenteret et sæt lovende data med lægemiddelkandidaten BI 456906 til behandling af fedme.
Og det peger i retning af, at midlet potentielt set kan få del i et hastigt voksende og meget attraktivt marked for fedmebehandling, vurderer Søren Løntoft Hansen, der er senioranalytiker hos Sydbank og følger markedet tæt med særligt fokus på Novo Nordisk og konkurrenten Eli Lilly, der begge har stærke fedmemidler på hylden.
Novo Nordisk oplever for tiden voldsom vækst med sit Wegovy, mens Eli Lilly er på vej på markedet med Mounjaro, der har vist endnu bedre resultater end Wegovy i de omfattende fase 3-studier.
Men selve markedet for fedmebehandling vil over de kommende år vokse så kraftigt, at der sagtens kan være plads til flere aktører, vurderer Søren Løntoft Hansen.
- Det ser umiddelbart rigtig godt ud med en vægtreducerende effekt på 15 pct. efter 46 uger. Man skal altid være ekstremt forsigtig med at sammenligne studier på tværs, men det kan ligne lidt en Wegovy-lookalike. Jeg tror, at markedet for fedmebehandling vil udvide sig markant over de kommende år, og der bør være plads til flere aktører på det her marked, siger han til MarketWire.
- Man kigger måske også lidt mere på den enkelte person i det her marked. Det er jo ikke sådan, at alle har brug for den høje dosis af Mounjaro. Der er forskel på at have et BMI på 38 og et BMI på 28 med relaterede følgesygdomme, hvor man ikke nødvendigvis behøver tabe sig plus 20 pct. af kropsvægten, fortsætter senioranalytikeren.
Han bider dog også mærke i, at studiet som Zealand Pharma har lavet sammen med partneren Boehringer Ingelheim, er lavet hos overvægtige og fede uden type 2-diabetes.
- Normalt ville man nok se lidt lavere vægttab hos type 2-diabetikere, siger Søren Løntoft Hansen.
.\˙ MarketWire
10/5 13:49
Zealand Pharma har onsdag præsenteret et sæt lovende data med lægemiddelkandidaten BI 456906 til behandling af fedme.
Og det peger i retning af, at midlet potentielt set kan få del i et hastigt voksende og meget attraktivt marked for fedmebehandling, vurderer Søren Løntoft Hansen, der er senioranalytiker hos Sydbank og følger markedet tæt med særligt fokus på Novo Nordisk og konkurrenten Eli Lilly, der begge har stærke fedmemidler på hylden.
Novo Nordisk oplever for tiden voldsom vækst med sit Wegovy, mens Eli Lilly er på vej på markedet med Mounjaro, der har vist endnu bedre resultater end Wegovy i de omfattende fase 3-studier.
Men selve markedet for fedmebehandling vil over de kommende år vokse så kraftigt, at der sagtens kan være plads til flere aktører, vurderer Søren Løntoft Hansen.
- Det ser umiddelbart rigtig godt ud med en vægtreducerende effekt på 15 pct. efter 46 uger. Man skal altid være ekstremt forsigtig med at sammenligne studier på tværs, men det kan ligne lidt en Wegovy-lookalike. Jeg tror, at markedet for fedmebehandling vil udvide sig markant over de kommende år, og der bør være plads til flere aktører på det her marked, siger han til MarketWire.
- Man kigger måske også lidt mere på den enkelte person i det her marked. Det er jo ikke sådan, at alle har brug for den høje dosis af Mounjaro. Der er forskel på at have et BMI på 38 og et BMI på 28 med relaterede følgesygdomme, hvor man ikke nødvendigvis behøver tabe sig plus 20 pct. af kropsvægten, fortsætter senioranalytikeren.
Han bider dog også mærke i, at studiet som Zealand Pharma har lavet sammen med partneren Boehringer Ingelheim, er lavet hos overvægtige og fede uden type 2-diabetes.
- Normalt ville man nok se lidt lavere vægttab hos type 2-diabetikere, siger Søren Løntoft Hansen.
.\˙ MarketWire
Potential weight-loss drug meets goals in mid-stage trial as race accelerates
https://www.reuters.com/business/healthcare-pharmaceuticals/zealand-boehringers-drug-meets-main-weight-loss-goal-mid-stage-trial-2023-05-10/
(Reuters - May 10, 2023)
....
"The obesity market will always come with affordability questions that will split the market into different pockets," said Leuchten.
Gareth Powell, head of healthcare at Zealand shareholder Polar Capital, said participants that were not yet up to the planned maintenance dose could be included in the overall tally, potentially heralding a better weight-loss percentage.
https://www.reuters.com/business/healthcare-pharmaceuticals/zealand-boehringers-drug-meets-main-weight-loss-goal-mid-stage-trial-2023-05-10/
(Reuters - May 10, 2023)
....
"The obesity market will always come with affordability questions that will split the market into different pockets," said Leuchten.
Gareth Powell, head of healthcare at Zealand shareholder Polar Capital, said participants that were not yet up to the planned maintenance dose could be included in the overall tally, potentially heralding a better weight-loss percentage.
