Company announcement - No. 15 / 2025
Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide
Body weight reductions of a mean of 11.6% after 28 weeks with dapiglutide escalated up to 26 mg, with 95% of trial participants being male, a median baseline BMI of 28.5 kg/m2, and no lifestyle modifications
Treatment with dapiglutide was assessed to be safe and well-tolerated with gastrointestinal adverse events consistent with the profile reported with other incretin-based therapies
Unique, dual mechanism, including GLP-2 activity, designed to target obesity-related comorbid conditions driven by low-grade inflammation
Copenhagen, Denmark, June 18, 2025 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces positive topline clinical results from Part 2 of a Phase 1b multiple ascending dose (MAD) trial, investigating safety, tolerability, and clinical effects of 28 weeks of treatment with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist1.
"We are very encouraged by the impressive weight loss with dapiglutide after 28 weeks that appears on par with the most efficacious once-weekly GLP-1 receptor agonist-based therapy on the market today, despite the almost entirely male and relatively lean trial population," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "Dapiglutide is a unique GLP-1 receptor agonist-based therapy, aiming to leverage a dual mechanism that includes GLP-2. Our mid- to late-stage obesity pipeline includes differentiated GLP-1 receptor agonist-based therapies that target people with obesity-related comorbid conditions, and our amylin analog, petrelintide, with potential as a foundational therapy for weight management, addressing unmet needs among the majority of people with overweight and obesity."
In this Part 2 of the Phase 1b MAD trial, a total of 30 participants (~93% male) with a median age of 44.5 years, a median baseline body weight of 91.9 kg, and a median baseline BMI of 28.8 kg/m2 were randomized to receive 28 weekly doses of either dapiglutide or placebo (2:1) within one dose cohort. At week 28, the estimated mean body weight decreased by 11.6% from baseline among participants on dapiglutide treatment. Placebo treatment resulted in a mean body weight decrease of 0.2% from baseline2. No lifestyle modifications, such as diet or exercise, were included in the trial.
Higher doses of dapiglutide compared to the prior 13-week Part 1 of the trial were assessed to be safe and well-tolerated in the trial, with no severe or serious treatment-emergent adverse events (TEAEs) reported. The vast majority of TEAEs were mild and the most common were gastrointestinal (GI), including nausea and vomiting. Two participants withdrew due to TEAEs, one of which was related to GI events. Overall, the number of GI events observed was consistent with clinical trials of other incretin-based therapies. A low number of participants reported injection site reactions, all of which were mild.
About the Phase 1b trial
The Phase 1b trial is a single-center, randomized, double-blind, placebo-controlled clinical trial in participants with overweight or obesity (eligible BMI 27.0 to 39.9 kg/m2), investigating safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of dapiglutide as subcutaneous injections using a dose escalation scheme (NCT06000891). No lifestyle modifications, such as diet or exercise, are included in the trial. The trial consists of Part 1 and Part 2.
Part 1 included 54 participants in three cohorts receiving 13 once-weekly doses of dapiglutide or placebo, with rapid dose escalation every second week. Participants randomized to the highest dose cohort (13 mg) received the target dose for a period of 5 weeks. Topline results from Part 1 showed placebo-adjusted reductions in body weight of up to a mean of 8.3% with dapiglutide after 13 weeks (up to 6.2% mean weight loss on dapiglutide; 2.1% mean weight gain on placebo)3. Detailed results from Part 1 of the Phase 1b MAD trial with dapiglutide will be presented at the American Diabetes Association's 85th Scientific Sessions in Chicago, Illinois on June 20, 2025.
Part 2 of the trial includes 30 participants receiving 28 once-weekly doses of dapiglutide up to 26 mg or placebo within one dose cohort, with dose escalation every fourth week.
About dapiglutide
Dapiglutide is a long-acting, dual GLP-1/GLP-2 receptor agonist for the potential treatment of obesity-related comorbidities driven by low-grade inflammation. This is a potentially first-in-class peptide designed to leverage the weight loss effects of a potent GLP-1 receptor agonist and address comorbidities associated with low-grade inflammation through improved intestinal barrier function by GLP-2 receptor activation.
About low-grade inflammation and obesity
Excess fat storage associated with obesity can trigger low-grade systemic inflammation through reduced intestinal barrier integrity, or "leaky gut". Obesity-related low-grade inflammation may result in several comorbidities, including cardiovascular disease, liver disease, inflammatory bowel disease, and neuroinflammation.
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 pharmaceutical 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 United States. For more information about Zealand's business and activities, please visit www.zealandpharma.com.
Contacts
Adam Lange (Investors)
Vice President, Investor Relations
[email protected]
Zealand Pharma announces positive topline results from 28-week Phase 1b trial with GLP-1/GLP-2 receptor dual agonist dapiglutide
Body weight reductions of a mean of 11.6% after 28 weeks with dapiglutide escalated up to 26 mg, with 95% of trial participants being male, a median baseline BMI of 28.5 kg/m2, and no lifestyle modifications
Treatment with dapiglutide was assessed to be safe and well-tolerated with gastrointestinal adverse events consistent with the profile reported with other incretin-based therapies
Unique, dual mechanism, including GLP-2 activity, designed to target obesity-related comorbid conditions driven by low-grade inflammation
Copenhagen, Denmark, June 18, 2025 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announces positive topline clinical results from Part 2 of a Phase 1b multiple ascending dose (MAD) trial, investigating safety, tolerability, and clinical effects of 28 weeks of treatment with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist1.
"We are very encouraged by the impressive weight loss with dapiglutide after 28 weeks that appears on par with the most efficacious once-weekly GLP-1 receptor agonist-based therapy on the market today, despite the almost entirely male and relatively lean trial population," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "Dapiglutide is a unique GLP-1 receptor agonist-based therapy, aiming to leverage a dual mechanism that includes GLP-2. Our mid- to late-stage obesity pipeline includes differentiated GLP-1 receptor agonist-based therapies that target people with obesity-related comorbid conditions, and our amylin analog, petrelintide, with potential as a foundational therapy for weight management, addressing unmet needs among the majority of people with overweight and obesity."
In this Part 2 of the Phase 1b MAD trial, a total of 30 participants (~93% male) with a median age of 44.5 years, a median baseline body weight of 91.9 kg, and a median baseline BMI of 28.8 kg/m2 were randomized to receive 28 weekly doses of either dapiglutide or placebo (2:1) within one dose cohort. At week 28, the estimated mean body weight decreased by 11.6% from baseline among participants on dapiglutide treatment. Placebo treatment resulted in a mean body weight decrease of 0.2% from baseline2. No lifestyle modifications, such as diet or exercise, were included in the trial.
Higher doses of dapiglutide compared to the prior 13-week Part 1 of the trial were assessed to be safe and well-tolerated in the trial, with no severe or serious treatment-emergent adverse events (TEAEs) reported. The vast majority of TEAEs were mild and the most common were gastrointestinal (GI), including nausea and vomiting. Two participants withdrew due to TEAEs, one of which was related to GI events. Overall, the number of GI events observed was consistent with clinical trials of other incretin-based therapies. A low number of participants reported injection site reactions, all of which were mild.
About the Phase 1b trial
The Phase 1b trial is a single-center, randomized, double-blind, placebo-controlled clinical trial in participants with overweight or obesity (eligible BMI 27.0 to 39.9 kg/m2), investigating safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of dapiglutide as subcutaneous injections using a dose escalation scheme (NCT06000891). No lifestyle modifications, such as diet or exercise, are included in the trial. The trial consists of Part 1 and Part 2.
Part 1 included 54 participants in three cohorts receiving 13 once-weekly doses of dapiglutide or placebo, with rapid dose escalation every second week. Participants randomized to the highest dose cohort (13 mg) received the target dose for a period of 5 weeks. Topline results from Part 1 showed placebo-adjusted reductions in body weight of up to a mean of 8.3% with dapiglutide after 13 weeks (up to 6.2% mean weight loss on dapiglutide; 2.1% mean weight gain on placebo)3. Detailed results from Part 1 of the Phase 1b MAD trial with dapiglutide will be presented at the American Diabetes Association's 85th Scientific Sessions in Chicago, Illinois on June 20, 2025.
Part 2 of the trial includes 30 participants receiving 28 once-weekly doses of dapiglutide up to 26 mg or placebo within one dose cohort, with dose escalation every fourth week.
About dapiglutide
Dapiglutide is a long-acting, dual GLP-1/GLP-2 receptor agonist for the potential treatment of obesity-related comorbidities driven by low-grade inflammation. This is a potentially first-in-class peptide designed to leverage the weight loss effects of a potent GLP-1 receptor agonist and address comorbidities associated with low-grade inflammation through improved intestinal barrier function by GLP-2 receptor activation.
About low-grade inflammation and obesity
Excess fat storage associated with obesity can trigger low-grade systemic inflammation through reduced intestinal barrier integrity, or "leaky gut". Obesity-related low-grade inflammation may result in several comorbidities, including cardiovascular disease, liver disease, inflammatory bowel disease, and neuroinflammation.
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 pharmaceutical 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 United States. For more information about Zealand's business and activities, please visit www.zealandpharma.com.
Contacts
Adam Lange (Investors)
Vice President, Investor Relations
[email protected]
18/6 2025 20:50 EliotSpitzer 1
126833 Dette er i mine øjne fine resultater, hvis vi sammenligner med vanlig GLP-1 behandling.
ZP skriver "Vægttab på gennemsnitligt 11,6% efter 28 uger med dapiglutid, der blev trappet op til 26 mg, hvor 95% af deltagerne i studiet var mænd, med en median baseline BMI på 28,5 kg/m², og uden livsstilsændringer." - 11.6% skal sammenlignes med nedenstående systematisk gennemgang litteratur gennemgang.
og ZP skriver videre:
"Behandling med dapiglutid vurderedes at være sikker og godt tolereret med gastrointestinale bivirkninger, der er i overensstemmelse med profilen rapporteret for andre incretin-baserede terapier. Unik, dobbelt mekanisme, inklusive GLP-2 aktivitet, designet til at målrette mod fedme-relaterede komorbiditeter drevet af lavgradig inflammation." - Bivirkningsprofil skal også holdes op imod systematisk gennemgang litteratur gennemgang.
Risk/benefit lagt sammen så syntes jeg at dette studie ser helt fint ud til at kunne finde en plads i markedet. Men jeg er ikke ekspert her. Glæder mig til at se andre gode kommentarer her.
En systematisk gennemgang fra 2025 af randomiserede kontrollerede forsøg om brugen af GLP-1 agonister til vægttab blandt voksne uden diabetes viste, at sammenlignet med placebo, førte tirzepatid (15 mg ugentligt) til op til 17,8% vægttab efter 72 uger, semaglutide (2,4 mg ugentligt) til op til 13,9% efter 68 uger, og liraglutid (3,0 mg dagligt) til op til 5,8% efter 26 uger. Retatrutid (12 mg ugentligt) viste det højeste vægttab på 22,1% efter 48 uger. Andre GLP-1 midler viste også varierende effektivitet. Bivirkninger var almindelige (80-97% vs. 63-100% med placebo), primært gastrointestinale (kvalme, opkastning, diarré, forstoppelse). Afbrydelse på grund af bivirkninger varierede fra 0% til 26% (vs. 0% til 9% med placebo).
Kilde for systematisk; Areesha Moiz, Kristian B. Filion, Helia Toutounchi, et al. Efficacy and Safety of Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss Among Adults Without Diabetes: A Systematic Review of Randomized Controlled Trials. Ann Intern Med.2025;178:199-217. [Epub 7 January 2025]. doi:10.7326/ANNALS-24-01590
ZP skriver "Vægttab på gennemsnitligt 11,6% efter 28 uger med dapiglutid, der blev trappet op til 26 mg, hvor 95% af deltagerne i studiet var mænd, med en median baseline BMI på 28,5 kg/m², og uden livsstilsændringer." - 11.6% skal sammenlignes med nedenstående systematisk gennemgang litteratur gennemgang.
og ZP skriver videre:
"Behandling med dapiglutid vurderedes at være sikker og godt tolereret med gastrointestinale bivirkninger, der er i overensstemmelse med profilen rapporteret for andre incretin-baserede terapier. Unik, dobbelt mekanisme, inklusive GLP-2 aktivitet, designet til at målrette mod fedme-relaterede komorbiditeter drevet af lavgradig inflammation." - Bivirkningsprofil skal også holdes op imod systematisk gennemgang litteratur gennemgang.
Risk/benefit lagt sammen så syntes jeg at dette studie ser helt fint ud til at kunne finde en plads i markedet. Men jeg er ikke ekspert her. Glæder mig til at se andre gode kommentarer her.
En systematisk gennemgang fra 2025 af randomiserede kontrollerede forsøg om brugen af GLP-1 agonister til vægttab blandt voksne uden diabetes viste, at sammenlignet med placebo, førte tirzepatid (15 mg ugentligt) til op til 17,8% vægttab efter 72 uger, semaglutide (2,4 mg ugentligt) til op til 13,9% efter 68 uger, og liraglutid (3,0 mg dagligt) til op til 5,8% efter 26 uger. Retatrutid (12 mg ugentligt) viste det højeste vægttab på 22,1% efter 48 uger. Andre GLP-1 midler viste også varierende effektivitet. Bivirkninger var almindelige (80-97% vs. 63-100% med placebo), primært gastrointestinale (kvalme, opkastning, diarré, forstoppelse). Afbrydelse på grund af bivirkninger varierede fra 0% til 26% (vs. 0% til 9% med placebo).
Kilde for systematisk; Areesha Moiz, Kristian B. Filion, Helia Toutounchi, et al. Efficacy and Safety of Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss Among Adults Without Diabetes: A Systematic Review of Randomized Controlled Trials. Ann Intern Med.2025;178:199-217. [Epub 7 January 2025]. doi:10.7326/ANNALS-24-01590
19/6 2025 07:25 ProInvestorNEWS 1126837 Zealand imponerer med data fra Dapiglutid: Jefferies ser vægttabspotentiale på 20 pct.
19/6 07:02
Der er tale om opmuntrende data fra Zealand Pharmas nyeste studie med vægttabskandidaten Dapiglutid, lyder vurderingen fra børshuset Jefferies.
Sent onsdag eftermiddag offentliggjorde biotekselskabet friske vægttabstal fra sit fase 1b-studie med Dapiglutid, der viste et vægttab på 11,6 pct. over 28 uger med en dosis på op mod 26mg.
- Selv om vi tidligere har antydet, at et vægttab på cirka 12 pct. eller over ville bygge tillid til Dapiglutids vægttabsprofil, mener vi, at resultaterne stadig bekræfter et potentiale for at nå et vægttab på over 20 pct. i fase 3, skriver Jefferies' analytiker Lucy Codrington i et notat.
- Vi er fortsat optimistiske omkring programmet under antagelsen, at større antiinflammatoriske fordele vil vise sig i senstadiestudierne og venter et topsalg på 3 mia. dollar, fortsætter hun.
Også bivirkningsprofilen for Dapiglutid betragtes som positiv.
Jefferies bemærker dog også, at markedets holdning til Zealand Pharma er på et lavt niveau i USA.
- Vores seneste samtaler med amerikanske investorer har fremhævet, at den kortsigtede stemning omkring Zealand Pharma er lav uden en ny større katalysator før første halvår af 2026, skriver Lucy Codrington.
- Dertil har de seneste konkurrencedygtige vægttabsdata fra Eli Lillys Eloralintid og Metseras månedlige MET-233i indikeret, at konkurrencen er stigende i amylin-feltet, hvilket for nuværende overskygger "best case"-værdien fra aftalen med Roche, fremgår det videre.
Jefferies ser dog mulighed for, at investorappetitten kan vende tilbage senere i 2025 forud for data for fase 2-data for Petrelintid og fase 3-data med Survodutid.
Børshuset gentager sit kursmål på 1050 kr., der afspejler et potentiale på 178 pct., og anbefalingen "køb".
Onsdag steg aktien i Zealand med 0,9 pct. til 380,50 kr. I årets løb er aktien dykket næsten 47 pct.
KAN FØRE TIL KURSSTIGNING
Aktien i Zealand Pharma har i år og særligt på det seneste været under pres, efter at Eli Lilly fremlagde opløftende vægttabsdata med sin amylin-analog Eloralintid.
De nye tal med Dapiglutid bør dog vække lettelse hos investorerne, mener Nordnets investeringsøkonom Per Hansen.
- Efter en massiv kursnedsmeltning, vil det være naturligt, at investorerne igen ser mere positivt på aktien i dagens handel, skriver han i en kommentar.
- Investorerne bør komme sig over forskrækkelsen og sende aktien op, fortsætter han.
.\˙ MarketWire
19/6 07:02
Der er tale om opmuntrende data fra Zealand Pharmas nyeste studie med vægttabskandidaten Dapiglutid, lyder vurderingen fra børshuset Jefferies.
Sent onsdag eftermiddag offentliggjorde biotekselskabet friske vægttabstal fra sit fase 1b-studie med Dapiglutid, der viste et vægttab på 11,6 pct. over 28 uger med en dosis på op mod 26mg.
- Selv om vi tidligere har antydet, at et vægttab på cirka 12 pct. eller over ville bygge tillid til Dapiglutids vægttabsprofil, mener vi, at resultaterne stadig bekræfter et potentiale for at nå et vægttab på over 20 pct. i fase 3, skriver Jefferies' analytiker Lucy Codrington i et notat.
- Vi er fortsat optimistiske omkring programmet under antagelsen, at større antiinflammatoriske fordele vil vise sig i senstadiestudierne og venter et topsalg på 3 mia. dollar, fortsætter hun.
Også bivirkningsprofilen for Dapiglutid betragtes som positiv.
Jefferies bemærker dog også, at markedets holdning til Zealand Pharma er på et lavt niveau i USA.
- Vores seneste samtaler med amerikanske investorer har fremhævet, at den kortsigtede stemning omkring Zealand Pharma er lav uden en ny større katalysator før første halvår af 2026, skriver Lucy Codrington.
- Dertil har de seneste konkurrencedygtige vægttabsdata fra Eli Lillys Eloralintid og Metseras månedlige MET-233i indikeret, at konkurrencen er stigende i amylin-feltet, hvilket for nuværende overskygger "best case"-værdien fra aftalen med Roche, fremgår det videre.
Jefferies ser dog mulighed for, at investorappetitten kan vende tilbage senere i 2025 forud for data for fase 2-data for Petrelintid og fase 3-data med Survodutid.
Børshuset gentager sit kursmål på 1050 kr., der afspejler et potentiale på 178 pct., og anbefalingen "køb".
Onsdag steg aktien i Zealand med 0,9 pct. til 380,50 kr. I årets løb er aktien dykket næsten 47 pct.
KAN FØRE TIL KURSSTIGNING
Aktien i Zealand Pharma har i år og særligt på det seneste været under pres, efter at Eli Lilly fremlagde opløftende vægttabsdata med sin amylin-analog Eloralintid.
De nye tal med Dapiglutid bør dog vække lettelse hos investorerne, mener Nordnets investeringsøkonom Per Hansen.
- Efter en massiv kursnedsmeltning, vil det være naturligt, at investorerne igen ser mere positivt på aktien i dagens handel, skriver han i en kommentar.
- Investorerne bør komme sig over forskrækkelsen og sende aktien op, fortsætter han.
.\˙ MarketWire
