Firm announcement “ No. 51 / 2024
U.S. Meals and Drug Administration points Full Response Letter for the glepaglutide New Drug Software for the remedy of quick bowel syndrome
The FDA concluded that Zealand Pharma (NASDAQ:)’s software didn’t meet the total necessities for substantial proof to ascertain the efficacy and security of the to-be-marketed dose of glepaglutide.Zealand Pharma will proceed the dialogue with the FDA to align on the trail towards acquiring regulatory approval in the united statesZealand Pharma expects to proceed with its present plans for a European Advertising and marketing Authorization Software submission in 2025.
Copenhagen, Denmark, December 19, 2024 “ Zealand Pharma A/S (Nasdaq: ZEAL) (Zealand) (CVR-no. 20045078), a biotechnology firm targeted on the invention and improvement of modern peptide-based medicines, as we speak introduced that the U.S. Meals and Drug Administration (FDA) has issued a Full Response Letter (CRL) for the corporate’s New Drug Software (NDA) for glepaglutide, a long-acting GLP-2 analog, beneath improvement for the remedy of grownup sufferers with quick bowel syndrome (SBS) with intestinal failure (IF) who’re depending on parenteral help.
The submitted NDA included a single randomized, placebo-controlled Part 3 registration trial, which is widespread for a uncommon illness indication corresponding to SBS. The trial consisted of two energetic remedy arms, a once-weekly and twice-weekly dosing arm, respectively. Remedy with glepaglutide twice-weekly demonstrated important and superior results in lowering parenteral help necessities in sufferers with SBS-IF in comparison with placebo. As soon as-weekly glepaglutide remedy resulted in a discount in parenteral help, however didn’t obtain statistical significance. Within the CRL, the FDA beneficial a further medical trial to offer additional proof to verify the efficacy and security of glepaglutide on the to-be-marketed dose.
Whereas we’re actually upset within the FDA’s determination, we stay assured that the information confirmed strong and compelling proof of each efficacy and security for glepaglutide remedy. We stay agency in our perception that glepaglutide supplies a big advance in GLP-2-based therapies for the potential remedy of SBS sufferers who’re depending on parenteral help, stated David Kendall, MD, Chief Medical (TASE:) Officer of Zealand Pharma. We’re dedicated to working with the company to align on the trail towards a regulatory approval, in order that we are able to deliver glepaglutide to sufferers within the U.S. In parallel, we anticipate to proceed with our present plans for a European Advertising and marketing Authorization Software submission in 2025.
Zealand Pharma expects to provoke a single Part 3 trial in 2025 that’s anticipated to help advertising and marketing authorizations for glepaglutide in geographies outdoors the U.S. and the EU and supply additional confirmatory proof for a regulatory resubmission within the U.S.
About glepaglutide
Glepaglutide is a long-acting GLP-2 analog in improvement as a possible remedy choice for brief bowel syndrome (SBS). Glepaglutide is being developed as a liquid product in an autoinjector designed for subcutaneous administration, aimed to cut back, or get rid of, the necessity for parenteral help in folks dwelling with SBS. The U.S. Meals and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the remedy of SBS.
Concerning the EASE medical program
The Part 3 program, named EASE, consists of 4 medical trials evaluating the potential for glepaglutide to cut back or get rid of the necessity for parenteral help in SBS sufferers with intestinal failure.
EASE-1 (NCT03690206) is a randomized, double-blind Part 3 trial that enrolled a complete of 106 SBS sufferers with intestinal failure who have been depending on parenteral help for no less than three days per week. Sufferers have been evenly randomized to obtain remedy with 10 mg glepaglutide administered both a couple of times weekly, or placebo. The first endpoint within the trial was absolutely the change in weekly parenteral help quantity from baseline at 24 weeks.
In complete, 102 of 106 collaborating sufferers accomplished EASE-1, of which 96 continued into the continuing two-year, long-term security and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial through which SBS sufferers continued their assigned remedy from EASE-1 with glepaglutide 10 mg a couple of times weekly. Sufferers who acquired placebo in EASE-1 have been re-randomized to remedy with both glepaglutide 10 mg a couple of times weekly. Sufferers who full EASE-2 are eligible to take part in EASE-3 (NCT04881825), evaluating glepaglutide administered as soon as weekly utilizing an auto-injector.
EASE-4 (NCT04991311) is a Part 3b trial to evaluate long-term results of glepaglutide on intestinal fluid and power uptake.
About quick bowel syndrome
Brief bowel syndrome (SBS) with intestinal failure is a fancy power and extreme situation related to diminished or full lack of intestinal operate through which people are depending on receiving fluids and diet parenterally. Whereas life-sustaining, parenteral help poses important restrictions on every day life and carries a danger of significant and life-threatening problems corresponding to sepsis, blood clots, liver harm and renal impairment.
About Zealand Pharma A/S Â
Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology firm targeted on the invention and improvement of peptide-based medicines. Greater than 10 drug candidates invented by Zealand have superior into medical improvement, of which two have reached the market and three candidates are in late-stage improvement. The corporate has improvement partnerships with quite a lot of pharma firms in addition to business partnerships for its marketed merchandise.
Zealand was based in 1998 and is headquartered in Copenhagen, Denmark, with a presence within the U.S. For extra details about Zealand’s enterprise and actions, please go to www.zealandpharma.com.
Ahead-Trying StatementsThis firm announcement accommodates forward-looking statements, as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995 in america, as amended, despite the fact that now not listed in america that is used as a definition to offer Zealand Pharma’s expectations or forecasts of future occasions concerning the analysis, improvement, and commercialization of pharmaceutical merchandise, the timing of the corporate’s medical trials and the reporting of information therefrom. These forward-looking statements could also be recognized by phrases corresponding to goal, anticipate, imagine, might, estimate, anticipate, forecast, purpose, intend, could, plan, attainable, potential, will, would, and different phrases and phrases of comparable which means. You shouldn’t place undue reliance on these statements, or the scientific information 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 aren’t restricted to, surprising prices or delays in medical trials and different improvement actions resulting from hostile security occasions or in any other case; surprising considerations which will come up from further information, evaluation or outcomes obtained throughout medical trials; our potential to efficiently market each new and current merchandise; modifications in reimbursement guidelines and governmental legal guidelines and associated interpretation thereof; government-mandated or market-driven worth decreases for our merchandise; introduction of competing merchandise; manufacturing issues; surprising progress in prices and bills; our potential to impact the strategic reorganization of our companies within the method deliberate; failure to guard and implement our information, mental property and different proprietary rights and uncertainties regarding mental property claims and challenges; regulatory authorities could require further data or additional research, or could reject, fail to approve or could delay approval of our drug candidates or growth of product labeling; failure to acquire regulatory approvals in different jurisdictions; publicity to product legal responsibility and different claims; rate of interest and foreign money trade price fluctuations; surprising contract breaches or terminations; inflationary pressures on the worldwide financial system; and political uncertainty, together with as a result of ongoing army battle in Ukraine. If all or any of such forward-looking statements show to be incorrect, our precise outcomes might differ materially and adversely from these anticipated or implied by such statements. The foregoing units forth many, however not all, of the elements 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/firm announcement and are primarily based on data accessible to Zealand Pharma as of the date of this launch/announcement. We don’t undertake to replace any of those forward-looking statements to replicate occasions or circumstances that happen after the date hereof. Info regarding prescription drugs (together with compounds beneath improvement) contained inside this materials just isn’t meant as promoting or medical recommendation.
Contacts
Supply: Zealand Pharma
Enterprise
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