ZEAL - Phase 1 Clinical Trial of Amylin Analog ZP8396
113432 Helge Larsen/PI-redaktør 24/6 2023 18:38
Press release - No. 6 / 2023
Zealand Pharma Presents Results from Phase 1 Clinical Trial of Amylin Analog ZP8396 at ADA Scientific Sessions
Body weight reductions reached up to a mean of 4.2% from baseline (4.8% placebo-corrected) within one week following a single dose of ZP8396 and were well-sustained over six weeks of observation
In development as an alternative non-incretin peptide therapy for the potential management of overweight and obesity
A 16-week multiple ascending dose (MAD) study of ZP8396 has been initiated
Copenhagen, Denmark, June 24, 2023 - Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") (CVR-no. 20045078) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that results from a Phase 1a clinical trial of ZP8396, the company's long-acting amylin analog, will be presented during a late-breaking poster session at the 2023 American Diabetes Association's 83rd Scientific Sessions in San Diego, CA, U.S. Topline results from the trial were previously announced in March 2023 (Company Announcement No. 7 / 2023).
"As part of our pipeline of differentiated candidates that target key metabolic pathways to deliver weight loss and address specific needs in the management of obesity, we are excited by the potential of amylin as an alternative, non-incretin treatment for overweight and obesity that may contribute to weight loss by acting on the brain via a potent satiety signal," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "We are very encouraged that treatment with a single dose of ZP8396 led to meaningful dose-dependent and consistent reductions in body weight that were sustained over six weeks in this Phase 1 study and look forward to results from further clinical trials of longer duration and at higher doses."
After one week, mean body weight reductions reached 2.6%, 3.6% and 4.2% from baseline following a single dose of 0.7 mg, 1.4 mg or 2.4 mg ZP8396, respectively. Reductions in body weight were dose-dependent, consistent and well-sustained during the additional five weeks of observation without further doses of ZP8396. Placebo-treated participants demonstrated a mean body weight increase of 0.6% after one week that continued to increase in most participants during the follow-up period.
The plasma half-life of ZP8396 was approximately 10 days, suitable for once-weekly administration.
ZP8396 was well tolerated in this study, with no serious or severe adverse events (AEs) and no withdrawals. The most frequent AEs were decreased appetite, nausea and vomiting; most events were mild and transient. Nausea and vomiting only occurred in the two highest dose groups. No anti-drug antibodies were detected.
Presentation details: Safety, tolerability, and clinical effects of ZP8396, a novel long-acting amylin analog: A single ascending dose trial
Late Breaking poster session: Saturday, June 24, 11:30 am -12:30 pm PT
A multiple ascending dose (MAD) study of ZP8396 is ongoing (NCT05613387). Part 1 of the MAD study includes six weeks of dosing and has completed enrollment. The company expects to present results from Part 1 at a scientific meeting in the second half of 2023. Zealand has initiated Part 2 of the MAD study that includes 16 weeks of dosing to potentially explore exposure to higher doses of ZP8396 including an assessment of up-titration. Topline results are anticipated in 2024. Additional clinical studies of longer duration will be necessary to fully assess the clinical potential of ZP8396.
About the SAD Study
The first-in-human study was designed to assess safety, pharmacokinetic and pharmacodynamic effects of a single dose of ZP8396 compared to placebo in healthy lean and overweight people (NCT05096598). A total of 56 participants (mean age 38.1 years; mean BMI 25.6) were randomized to receive ZP8396 or placebo (6:2) within seven cohorts evaluating doses of 0.04 mg, 0.08 mg, 0.16 mg, 0.35 mg, 0.70 mg, 1.40 mg, and 2.40 mg administered subcutaneously. Participants were followed for six weeks.
About ZP8396
ZP8396 is an investigational, potent long-acting amylin analog designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP-1 analogs. Amylin analogs hold potential as both single agents as well as combination therapies for the treatment of obesity. ZP8936 has demonstrated the potential to reduce body weight and improve glycemia in preclinical models of obesity and diabetes.
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 several 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 Statements
This company announcement contains forward-looking statements that provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. These forward-looking statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. 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, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; and product liability claims. 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. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
Contacts:
Adam Lange (Investors)
Investor Relations Officer
Zealand Pharma
akl@zealandpharma.com
Anna Krassowska, PhD (Investors and Media)
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
ank@zealandpharma.com
Zealand Pharma Presents Results from Phase 1 Clinical Trial of Amylin Analog ZP8396 at ADA Scientific Sessions
Body weight reductions reached up to a mean of 4.2% from baseline (4.8% placebo-corrected) within one week following a single dose of ZP8396 and were well-sustained over six weeks of observation
In development as an alternative non-incretin peptide therapy for the potential management of overweight and obesity
A 16-week multiple ascending dose (MAD) study of ZP8396 has been initiated
Copenhagen, Denmark, June 24, 2023 - Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") (CVR-no. 20045078) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that results from a Phase 1a clinical trial of ZP8396, the company's long-acting amylin analog, will be presented during a late-breaking poster session at the 2023 American Diabetes Association's 83rd Scientific Sessions in San Diego, CA, U.S. Topline results from the trial were previously announced in March 2023 (Company Announcement No. 7 / 2023).
"As part of our pipeline of differentiated candidates that target key metabolic pathways to deliver weight loss and address specific needs in the management of obesity, we are excited by the potential of amylin as an alternative, non-incretin treatment for overweight and obesity that may contribute to weight loss by acting on the brain via a potent satiety signal," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "We are very encouraged that treatment with a single dose of ZP8396 led to meaningful dose-dependent and consistent reductions in body weight that were sustained over six weeks in this Phase 1 study and look forward to results from further clinical trials of longer duration and at higher doses."
After one week, mean body weight reductions reached 2.6%, 3.6% and 4.2% from baseline following a single dose of 0.7 mg, 1.4 mg or 2.4 mg ZP8396, respectively. Reductions in body weight were dose-dependent, consistent and well-sustained during the additional five weeks of observation without further doses of ZP8396. Placebo-treated participants demonstrated a mean body weight increase of 0.6% after one week that continued to increase in most participants during the follow-up period.
The plasma half-life of ZP8396 was approximately 10 days, suitable for once-weekly administration.
ZP8396 was well tolerated in this study, with no serious or severe adverse events (AEs) and no withdrawals. The most frequent AEs were decreased appetite, nausea and vomiting; most events were mild and transient. Nausea and vomiting only occurred in the two highest dose groups. No anti-drug antibodies were detected.
Presentation details: Safety, tolerability, and clinical effects of ZP8396, a novel long-acting amylin analog: A single ascending dose trial
Late Breaking poster session: Saturday, June 24, 11:30 am -12:30 pm PT
A multiple ascending dose (MAD) study of ZP8396 is ongoing (NCT05613387). Part 1 of the MAD study includes six weeks of dosing and has completed enrollment. The company expects to present results from Part 1 at a scientific meeting in the second half of 2023. Zealand has initiated Part 2 of the MAD study that includes 16 weeks of dosing to potentially explore exposure to higher doses of ZP8396 including an assessment of up-titration. Topline results are anticipated in 2024. Additional clinical studies of longer duration will be necessary to fully assess the clinical potential of ZP8396.
About the SAD Study
The first-in-human study was designed to assess safety, pharmacokinetic and pharmacodynamic effects of a single dose of ZP8396 compared to placebo in healthy lean and overweight people (NCT05096598). A total of 56 participants (mean age 38.1 years; mean BMI 25.6) were randomized to receive ZP8396 or placebo (6:2) within seven cohorts evaluating doses of 0.04 mg, 0.08 mg, 0.16 mg, 0.35 mg, 0.70 mg, 1.40 mg, and 2.40 mg administered subcutaneously. Participants were followed for six weeks.
About ZP8396
ZP8396 is an investigational, potent long-acting amylin analog designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP-1 analogs. Amylin analogs hold potential as both single agents as well as combination therapies for the treatment of obesity. ZP8936 has demonstrated the potential to reduce body weight and improve glycemia in preclinical models of obesity and diabetes.
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 several 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 Statements
This company announcement contains forward-looking statements that provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. These forward-looking statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. 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, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; and product liability claims. 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. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
Contacts:
Adam Lange (Investors)
Investor Relations Officer
Zealand Pharma
akl@zealandpharma.com
Anna Krassowska, PhD (Investors and Media)
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
ank@zealandpharma.com
