Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis
Company announcement - No. 8 / 2024
Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis
Survodutide has potential to become best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH)*, after meeting its primary and key secondary endpoint following 48 weeks of treatment versus placebo in a Phase 2 trial
Survodutide, a novel glucagon/GLP-1 receptor dual agonist, has demonstrated efficacy in people with obesity, and statistically significant results in MASH suggest the potential to lead to clinically meaningful benefits across the cardiovascular, renal, and metabolic spectrum
Full data from the Phase 2 trial will be presented in the coming months
Copenhagen, Denmark, February 26, 2024 - Zealand Pharma A/S (Nasdaq: ZEAL) today announced that Boehringer Ingelheim has reported that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase 2 trial [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring). Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. Full data will be presented in the coming months.
"We are very excited by the positive topline Phase 2 trial results for survodutide in MASH announced today by Boehringer Ingelheim and we look forward to the planned disclosure of the full data at a scientific congress in the first half of this year," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "Furthermore, we are delighted with the announcement that Boehringer intends to move forward with further development in MASH as quickly as possible, as they progress with study recruitment in the ongoing Phase 3 clinical trial program for obesity."
The double-blind, placebo-controlled Phase 2 trial studied three doses of survodutide at 2.4 mg, 4.8 mg, and 6.0 mg. Top-line results demonstrated an improvement in MASH, at all doses explored in the trial. Treatment with survodutide did not show unexpected safety or tolerability issues, including at the higher dose of 6.0 mg.
For additional information please refer to Boehringer Ingelheim's press release from today available at survodutide top-line results MASH fibrosis ' Boehringer Ingelheim (boehringer-ingelheim.com)
About Survodutide (BI 456906)
Survodutide is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action that activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions.
Survodutide was co-invented by Boehringer Ingelheim and Zealand Pharma. Boehringer is funding all activities and is exclusively responsible for clinical development. Survodutide has received U.S. FDA Fast Track Designation for the treatment of MASH and fibrosis. Survodutide is also being evaluated in five Phase 3 trials as part of the SYNCHRONIZE clinical program for people living with overweight and obesity. Further information is available on clinicaltrials.gov.
*Boehringer Ingelheim's Phase 2 trial is registered on clinicaltrials.gov as 'A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)' prior to a 2023 nomenclature recommendation made by a number of multinational liver societies including EASL, AASLD and ALEH to update non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD), and to update non-alcoholic steatohepatitis (NASH) with metabolic dysfunction-associated steatohepatitis (MASH).
Contact:
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
Company announcement - No. 8 / 2024
Zealand Pharma announces Boehringer Ingelheim survodutide Phase 2 trial shows 83% of adults treated achieved groundbreaking results in liver disease due to MASH, with significant improvements in fibrosis
Survodutide has potential to become best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH)*, after meeting its primary and key secondary endpoint following 48 weeks of treatment versus placebo in a Phase 2 trial
Survodutide, a novel glucagon/GLP-1 receptor dual agonist, has demonstrated efficacy in people with obesity, and statistically significant results in MASH suggest the potential to lead to clinically meaningful benefits across the cardiovascular, renal, and metabolic spectrum
Full data from the Phase 2 trial will be presented in the coming months
Copenhagen, Denmark, February 26, 2024 - Zealand Pharma A/S (Nasdaq: ZEAL) today announced that Boehringer Ingelheim has reported that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase 2 trial [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring). Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. Full data will be presented in the coming months.
"We are very excited by the positive topline Phase 2 trial results for survodutide in MASH announced today by Boehringer Ingelheim and we look forward to the planned disclosure of the full data at a scientific congress in the first half of this year," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "Furthermore, we are delighted with the announcement that Boehringer intends to move forward with further development in MASH as quickly as possible, as they progress with study recruitment in the ongoing Phase 3 clinical trial program for obesity."
The double-blind, placebo-controlled Phase 2 trial studied three doses of survodutide at 2.4 mg, 4.8 mg, and 6.0 mg. Top-line results demonstrated an improvement in MASH, at all doses explored in the trial. Treatment with survodutide did not show unexpected safety or tolerability issues, including at the higher dose of 6.0 mg.
For additional information please refer to Boehringer Ingelheim's press release from today available at survodutide top-line results MASH fibrosis ' Boehringer Ingelheim (boehringer-ingelheim.com)
About Survodutide (BI 456906)
Survodutide is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action that activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions.
Survodutide was co-invented by Boehringer Ingelheim and Zealand Pharma. Boehringer is funding all activities and is exclusively responsible for clinical development. Survodutide has received U.S. FDA Fast Track Designation for the treatment of MASH and fibrosis. Survodutide is also being evaluated in five Phase 3 trials as part of the SYNCHRONIZE clinical program for people living with overweight and obesity. Further information is available on clinicaltrials.gov.
*Boehringer Ingelheim's Phase 2 trial is registered on clinicaltrials.gov as 'A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)' prior to a 2023 nomenclature recommendation made by a number of multinational liver societies including EASL, AASLD and ALEH to update non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD), and to update non-alcoholic steatohepatitis (NASH) with metabolic dysfunction-associated steatohepatitis (MASH).
Contact:
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com
26/2 2024 09:40 ProInvestorNEWS 7
118948 Zealand og Boehringer betegner fase 2-resultater i fedtlever som "skelsættende"
26.2.2024 08.18 • MarketWire •
(opdateres)
Zealand Pharma og partneren Boehringer Ingelheim har opnået, hvad der betegnes som skelsættende resultater i et fase 2-studie med lægemiddelkandidaten Survodutid til behandling af fedtlever, eller MASH.
I studiet opnåede op mod 83 pct. af patienterne, der fik Survodutid, forbedringer af leversygdommen, mens der var tale om 18,2 pct., der modtog placebo.
Forskellen på 64,8 pct. er statistisk signifikant, og lægemidlet mødte dermed den primære målsætning for studiet.
Desuden nåede Survodutid alle de sekundære endemål, herunder en væsentlig forbedring inden leverfibrose, der er ardannelser i leveren.
.\˙ MarketWire
26.2.2024 08.18 • MarketWire •
(opdateres)
Zealand Pharma og partneren Boehringer Ingelheim har opnået, hvad der betegnes som skelsættende resultater i et fase 2-studie med lægemiddelkandidaten Survodutid til behandling af fedtlever, eller MASH.
I studiet opnåede op mod 83 pct. af patienterne, der fik Survodutid, forbedringer af leversygdommen, mens der var tale om 18,2 pct., der modtog placebo.
Forskellen på 64,8 pct. er statistisk signifikant, og lægemidlet mødte dermed den primære målsætning for studiet.
Desuden nåede Survodutid alle de sekundære endemål, herunder en væsentlig forbedring inden leverfibrose, der er ardannelser i leveren.
.\˙ MarketWire
26/2 2024 11:36 Helge Larsen/PI-redaktør 4118950 Zealand Pharma og partneren Boehringer Ingelheim har mandag præsenteret, hvad de betegner som "skelsættende" resultater med lægemiddelkandidaten Survodutid til behandling af fedtlever, eller MASH.
Og resultaterne er ikke bare gode. De er ifølge Adam Steensberg, topchef i Zealand Pharma, umiddelbart bedre end de datasæt, som store selskaber som Novo Nordisk og Eli Lilly har præsenteret i fase 2-studier med deres lægemiddelkandidater mod MASH.
- Det er i min bog skelsættende data, også når man sammenligner med de data, der er kommet ud fra tilsvarende molekyler. Så ser det her bare stærkt ud, siger Adam Steensberg til MarketWire.
Han peger på, at Boehringer rammer alle de sekundære endemål, herunder en væsentlig forbedring inden for leverfibrose, der er ardannelser i leveren. Det har Lilly og Novo ikke tidligere formået at vise.
- Og fibrose er jo altså den væsentlige ting, man ønsker at få gjort noget ved. Så det sparker det her molekyle op i en anden liga i min verden, siger Adam Steensberg.
Han glæder sig over, at Boehringer på baggrund af datasættet har besluttet at gå videre med udviklingen af Survodutid i MASH så hurtigt som muligt.
HAR FÅET FORLOMME AF MYNDIGHEDERNE
Midlet har både i Europa og USA fået særlig prioritet hos myndighederne. I USA har den amerikanske lægemiddelmyndighed, FDA, givet "Fast Track" til Survodutid. Derved holder lægemiddelstyrelsen døren på klem for en godkendelse baseret på tidlige data, men betinget af, at der gennemføres yderligere studier.
- Det er jo Boehringer, der har dialogen med FDA, og ligesom skal guide om det. De har også fået regulatorisk forlomme i Europa for det her program, og vi er sikre på, at de arbejder for at se, hvor hurtigt det kan skride frem. Men vi forventer, at der skal et studie mere til, siger Adam Steensberg.
Tidligere har den amerikanske medicinalkæmpe Eli Lilly vist forbedringer med sin lægemiddelkandidat Tirzepatid i et fase 2-studie i MASH, men studiet var ikke designet til at vise forbedringer i leverfibrose.
Novo er i færd med et fase 3-studie i MASH med Semaglutid, kendt som Ozempic og Wegovy mod type 2-diabetes og svær overvægt, og ventes ifølge Barclays at komme med data i slutningen af i år.
Boehringer viste i studiet, at op mod 83 pct. af patienterne, der fik Survodutid, opnåede forbedringer af leversygdommen, mens der var tale om 18,2 pct., der modtog placebo.
Desuden nåede Survodutid alle de sekundære endemål, herunder altså en væsentlig forbedring inden for leverfibrose.
Alle de doser, der blev undersøgt i studiet med Survodutid, gav anledning til forbedringer. Der blev ikke set uventede bivirkninger, heller ikke i den højeste dosisudgave.
Den fulde datapakke vil blive præsenteret i løbet af de kommende måneder.
Aktien belønnes i den grad efter studiedataene med et plus på hele 21 pct. til 578,50 kr.
.\˙ MarketWire
Og resultaterne er ikke bare gode. De er ifølge Adam Steensberg, topchef i Zealand Pharma, umiddelbart bedre end de datasæt, som store selskaber som Novo Nordisk og Eli Lilly har præsenteret i fase 2-studier med deres lægemiddelkandidater mod MASH.
- Det er i min bog skelsættende data, også når man sammenligner med de data, der er kommet ud fra tilsvarende molekyler. Så ser det her bare stærkt ud, siger Adam Steensberg til MarketWire.
Han peger på, at Boehringer rammer alle de sekundære endemål, herunder en væsentlig forbedring inden for leverfibrose, der er ardannelser i leveren. Det har Lilly og Novo ikke tidligere formået at vise.
- Og fibrose er jo altså den væsentlige ting, man ønsker at få gjort noget ved. Så det sparker det her molekyle op i en anden liga i min verden, siger Adam Steensberg.
Han glæder sig over, at Boehringer på baggrund af datasættet har besluttet at gå videre med udviklingen af Survodutid i MASH så hurtigt som muligt.
HAR FÅET FORLOMME AF MYNDIGHEDERNE
Midlet har både i Europa og USA fået særlig prioritet hos myndighederne. I USA har den amerikanske lægemiddelmyndighed, FDA, givet "Fast Track" til Survodutid. Derved holder lægemiddelstyrelsen døren på klem for en godkendelse baseret på tidlige data, men betinget af, at der gennemføres yderligere studier.
- Det er jo Boehringer, der har dialogen med FDA, og ligesom skal guide om det. De har også fået regulatorisk forlomme i Europa for det her program, og vi er sikre på, at de arbejder for at se, hvor hurtigt det kan skride frem. Men vi forventer, at der skal et studie mere til, siger Adam Steensberg.
Tidligere har den amerikanske medicinalkæmpe Eli Lilly vist forbedringer med sin lægemiddelkandidat Tirzepatid i et fase 2-studie i MASH, men studiet var ikke designet til at vise forbedringer i leverfibrose.
Novo er i færd med et fase 3-studie i MASH med Semaglutid, kendt som Ozempic og Wegovy mod type 2-diabetes og svær overvægt, og ventes ifølge Barclays at komme med data i slutningen af i år.
Boehringer viste i studiet, at op mod 83 pct. af patienterne, der fik Survodutid, opnåede forbedringer af leversygdommen, mens der var tale om 18,2 pct., der modtog placebo.
Desuden nåede Survodutid alle de sekundære endemål, herunder altså en væsentlig forbedring inden for leverfibrose.
Alle de doser, der blev undersøgt i studiet med Survodutid, gav anledning til forbedringer. Der blev ikke set uventede bivirkninger, heller ikke i den højeste dosisudgave.
Den fulde datapakke vil blive præsenteret i løbet af de kommende måneder.
Aktien belønnes i den grad efter studiedataene med et plus på hele 21 pct. til 578,50 kr.
.\˙ MarketWire
