Today techs Zealand Pharma Declares Oral Presentation of Section 2 Information

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Press launch – No. 6 / 2022

Zealand Pharma Declares Oral Presentation of Section 2 Information for BI 456906 on the 58th Annual Assembly of the European Affiliation for the Research of Diabetes (EASD)

  • BI 456906 successfully lowered HbA1c as much as -1.88% at week 16 in sufferers with kind 2 diabetes within the Section 2 scientific trial
  • Preclinical pharmacology of BI 456906 helps ongoing Section 2 research in weight problems or non-alcoholic steatohepatitis

Copenhagen, Denmark and Boston MA, U.S. September 21, 2022  – Zealand Pharma A/S (CVR-no. 20045078) a biotechnology firm centered on the invention and improvement of modern peptide-based medicines, at this time introduced the presentation of information from the Boehringer Ingelheim-sponsored Section 2 scientific trial of BI 456906, a glucagon receptor/glucagon-like peptide-1 receptor (GCGR/GLP-1R) twin agonist, in sufferers with kind 2 diabetes on the 58th Annual Assembly of the European Affiliation for the Research of Diabetes (EASD) being held in Stockholm September 19 – 23, 2022. Preclinical knowledge on BI 456906 will even be offered on the EASD annual assembly. BI 456906 is being developed by Boehringer Ingelheim and was co-invented with Zealand Pharma.

“We’re delighted with the info offered at EASD from Boehringer Ingelheim’s Section 2 trial of the twin glucagon/GLP-1 receptor agonist BI 456906 that confirmed efficient reducing of HbA1c of as much as -1.88% in individuals with kind 2 diabetes at 16 weeks in comparison with -1.47% noticed following open-label therapy with the GLP-1 receptor agonist semaglutide,” mentioned David Kendall, MD, Chief Medical Officer of Zealand Pharma. “We stay up for the outcomes from this Section 2 trial’s secondary endpoints associated to the adjustments in body weight following therapy with BI 456906 to be reported at Weight problems Week 2022 later this 12 months.”

The abstracts of the oral displays can be found at https://www.easd.org/programme-2022.html and the info are summarized as follows:

Title: A number of dose-ranging research of the novel glucagon/GLP-1 receptor twin agonist BI 456906 vs placebo and open-label weekly semaglutide reference management in kind 2 diabetes (Summary quantity: 613)
Authors: J. Rosenstock, M. Blüher, B. Schmid, J. Hoefler, A. Hennige
Session: Quick Oral Discussions Occasion D – SO 46 Incretins in all places
Date and Time: Wednesday, 21 September 2022, 1:15 – 2:15 PM CET

Presentation Highlights: Remedy with BI 456906 resulted in dose-dependent HbA1c reductions, as much as a most of -1.88% at Week 16 in individuals with kind 2 diabetes (T2D) and confirmed better HbA1c reducing than with open-label semaglutide 1.0mg within the Section 2 trial. The security and tolerability profile that included gastrointestinal (GI) issues, equivalent to nausea and vomiting, as essentially the most continuously reported opposed occasions, was as is anticipated with greater rising doses of GLP-1 receptor agonists. Most opposed occasions had been reported in the course of the dose-escalation section of the trial, and subsequently slower escalation schemes could mitigate the frequency.

  • The Section 2 placebo-controlled, double-blind trial enrolled individuals with T2D on secure metformin background today techs remedy. Individuals had been randomized to obtain a number of rising doses of BI 456906 in certainly one of six dose teams, placebo or open-label weekly semaglutide 1.0mg for 16 weeks. Extra details about the design of the Section 2 trial is at ClinicalTrials.gov (NCT04153929).
  • Completely different doses of BI 456906 had been escalated each 1–2 weeks to make sure that 10 weeks had been spent on a upkeep dose.
  • The first endpoint was the change today techs from baseline in HbA1c after 16 weeks of therapy. Secondary endpoints associated to the adjustments in body weight from baseline are anticipated to be reported later this 12 months.
  • Remedy with BI 456906 led to dose-dependent decreases in HbA1c, with imply reductions of -0.93% to -1.88% at 16 weeks throughout the six dose teams, in contrast with -0.25% seen with placebo. Remedy with open-label weekly semaglutide at 1.0mg led to a lower in HbA1c of -1.47%.
  • Adversarial occasions had been reported in 78% of all contributors receiving BI 456906. Drug-related opposed occasions had been reported for 59% of BI 456906-treated contributors and 38% of contributors handled with open-label semaglutide. These had been most continuously GI issues equivalent to nausea and vomiting.
  • Drug-related critical opposed occasions had been reported for 4 contributors handled with BI 456906 throughout dose teams, all of which resolved as soon as therapy was stopped, and for no contributors receiving placebo.
  • Adversarial occasions led to therapy discontinuation in 16% of sufferers receiving BI 456906, 5% receiving placebo and 4% receiving open-label semaglutide.
  • Slower dose escalations over an extended period are anticipated to mitigate GI opposed occasions.

Title: BI 456906, structural properties and pharmacology of the novel glucagon and glucagon-like peptide-1 receptor (GCGR/GLP1R) twin agonist (Summary quantity 570)
Authors: R. Augustin, T. Zimmermann, L. Thomas, T. Baader-Pagler, P. Haebel, E. Simon, H. Klein, R. Santhanam, W. Reindl, B. Bajrami, W. Rist, I. Uphues, D. Hamprecht, H. Neubauer
Session: Quick Oral Discussions Occasion E – SO 41 Incretins: fundamental science
Date and Time: Thursday, 22 September 2022, 12:00 – 1:00 PM today techs CET

Presentation Highlights: BI 456906, by simultaneous activation of the GCGR and GLP-1R, achieved a physique weight reducing efficacy that’s superior to GLP-1R agonist semaglutide and is attributed to a rise in vitality expenditure. Transcriptional profiling offered insights into the mechanism of motion for BI 456906 within the liver with potential human relevance for sufferers with NASH. Taken collectively, the pharmacology of BI 456906 suggests scientific advantages for sufferers with weight problems and sufferers with NASH which is in assist of the present scientific applications.

About BI 456906

BI 456906 is a twin agonist, appearing on glucagon (GCG) receptors and glucagon-like peptide-1 (GLP-1) receptors to control vitality and glucose homeostasis, and which is anticipated to enhance the metabolic profile of handled people. BI 456906 has been proven to scale back body weight in preclinical and scientific research.

BI 456906 was co-invented by Boehringer Ingelheim by way of a collaboration settlement with Zealand Pharma. Boehringer Ingelheim is at the moment investigating the GCGR/GLP-1R twin agonist in two section 2 trials for individuals with weight problems or who’re chubby (NCT04667377) and for individuals with non-alcoholic steatohepatitis (NASH; NCT04771273). Below the phrases of the settlement, Boehringer Ingelheim funds all analysis, improvement and commercialization actions associated to BI 456906. Zealand Pharma is eligible to obtain as much as EUR 345 million in excellent milestone funds, and high-single to low-double digit royalties on international gross sales.

About Zealand Pharma A/S 

Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology firm centered on the invention and improvement of peptide-based medicines. Greater than 10 drug candidates invented by Zealand have superior into scientific improvement, of which two have reached the market and three candidates are in late-stage improvement. The corporate today techs has improvement and partnerships with numerous blue-chip pharma firms in addition to business partnerships for its marketed merchandise.

Based in 1998 and headquartered in Copenhagen, Denmark, Zealand has a workforce within the U.S. For extra details about Zealand’s enterprise and actions, please go to http://www.zealandpharma.com.

Ahead-Wanting Statements

This press launch accommodates “forward-looking statements”, as that time period is outlined within the Personal Securities Litigation Reform Act of 1995, as amended, that present Zealand Pharma’s expectations or forecasts of future occasions concerning the analysis, improvement and commercialization of pharmaceutical merchandise. These forward-looking statements could also be recognized by phrases equivalent to “intention,” “anticipate,” “imagine,” “may,” “estimate,” “anticipate,” “forecast,” “objective,” “intend,” “could,” “plan,” “potential,” “potential,” “will,” “would” and different phrases and phrases of comparable that means. You shouldn’t place undue reliance on these statements, or the scientific knowledge offered. The reader is cautioned to not depend on these forward-looking statements. Such forward-looking statements are topic to dangers, uncertainties and inaccurate assumptions, which can trigger precise outcomes to vary materially from expectations set forth herein and should trigger all or any of such forward-looking statements to be incorrect, and which embody, however will not be restricted to, the incidence of opposed security occasions; dangers of surprising prices or delays; surprising considerations that will come up from extra knowledge, evaluation or outcomes obtained throughout scientific trials; failure to guard and implement our knowledge, mental property and different proprietary rights and uncertainties referring to mental property claims and challenges; regulatory authorities could require extra info or additional research, or could fail to approve or could delay approval of our drug candidates or growth of product labelling; failure to acquire regulatory approvals in different jurisdictions; product legal responsibility claims; and the direct and oblique impacts of the continued COVID-19 pandemic on our enterprise, today techs outcomes of operations and monetary situation. If all or any of such forward-looking statements show to be incorrect, our precise outcomes may differ materially and adversely from these anticipated or implied by such statements. The foregoing units forth many, however not all, of the components that might trigger precise outcomes to vary from our expectations in any forward-looking assertion. All such forward-looking statements converse solely as of the date of this press launch and are based mostly on info obtainable to Zealand Pharma as of the date of this launch. We don’t undertake to replace any of those forward-looking statements to mirror occasions or circumstances that happen after the date hereof. Data regarding prescribed drugs (together with compounds underneath improvement) contained inside this materials just isn’t meant as promoting or medical recommendation.

Contacts:

Anna Krassowska, PhD
Vice President, Investor Relations & Company Communications
Zealand Pharma A/S
ank@zealandpharma.com

David Rosen (U.S. Media)
Argot Companions
media@zealandpharma.com

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