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Blog Exposure - Zealand’s End-of-Phase-2 Meeting with FDA Confirmed the Path Forward for Phase-3 Program of Glepaglutide for Short Bowel Syndrome

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LONDON, UK / ACCESSWIRE / April 30, 2018 / Active-Investors.com has just released a free research report on Zealand Pharma A/S (NASDAQ: ZEAL) ("Zealand"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ZEAL as the Company's latest news hit the wire. On April 26, 2018, the Company announced that it has successfully concluded the End-of-Phase-2 meeting with the US Food and Drug Administration (FDA) regarding the Phase-3 program for Zealand's long-acting GLP-2 analog, glepaglutide, in short bowel syndrome (SBS) patients. Register today and get access to over 1000 Free Research Reports by joining our site below:


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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Zealand Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


Zealand to Initiate Phase-3 Trial in Q3 2018

The outcome of the meeting confirms the path forward for the glepaglutide Phase-3 program. The pivotal Phase-3 trial will be randomized, double-blind, and placebo controlled with once-weekly and twice-weekly dosing regimens. The trial will enroll around 130 patients at multiple sites across the US, EU, and Canada. Zealand expects to initiate the pivotal Phase-3 trial in Q3 2018.

Acceptance by the FDA to Proceed into Phase-3 is an Important Step Forward for Zealand

Commenting on the announcement, Britt Meelby Jensen, President and Chief Executive Officer of Zealand, stated that the Company is encouraged by the positive outcome of the End-of-Phase 2 meeting regarding glepaglutide for treatment of short bowel syndrome. Britt added that the acceptance by the FDA to proceed into Phase-3 is an important step forward for Zealand and for patients suffering from short bowel syndrome.

Glepaglutide Met Primary Endpoint in Phase-2 Trial in Patients with SBS

In June 2017, the Company announced positive results from the Phase-2 trial of glepaglutide in adult patients with SBS. The trial investigated the effect of three different once-daily doses of glepaglutide (10 mg, 1 mg, and 0.1 mg). A total of 16 SBS patients completed the trial. The first dose was administered over a three-week period, followed by a washout period of four weeks and then treatment with the second dose for a further three weeks. The aim was to assess the efficacy, safety and tolerability of different doses of glepaglutide in SBS patients. The primary trial objective was the effect of glepaglutide on patients' intestinal absorptive capacity, measured as reduction in wet weight fecal output. Glepaglutide successfully met the primary study endpoint of reducing fecal wet weight output, with 833 grams/day and 593 grams/day in the 10 mg and 1 mg dose groups, corresponding to a relative decrease of 30% and 23%, respectively. In addition, glepaglutide also appeared to increase energy absorption for the combined 10 mg and 1 mg dose group. Pharmacokinetic data confirmed the long half-life of glepaglutide when dosed daily.

About Short Bowel Syndrome

Short bowel syndrome (SBS) is a malabsorption disorder caused by a lack of functional small intestine. The primary symptom is diarrhea, which can result in dehydration, malnutrition, and weight loss. Other symptoms may include bloating, heartburn, feeling tired, lactose intolerance, and foul-smelling stool. Complications can include anemia and kidney stones. Most cases are due to the surgical removal of a large portion of the small intestine. This is most often required due to Crohn's disease in adults and necrotizing enterocolitis in young children. The most severely affected people are dependent on daily parenteral support. This requires them to be connected to infusion lines and pumps, which pose significant restrictions on their ability to engage in daily activities.

About Glepaglutide

Glepaglutide is a long-acting GLP-2 analog in development for the treatment of SBS. The trial investigates the potential for less than once-daily dosing. The FDA has granted an orphan drug designation to glepaglutide for the treatment of the SBS.

About Zealand Pharma A/S

Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand Pharma is a biotechnology company focused on the discovery, design, and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under licence collaborations with Sanofi, Boehringer Ingelheim, and Helsinn.

Stock Performance Snapshot

April 27, 2018 - At Friday's closing bell, Zealand Pharma's stock declined 1.98%, ending the trading session at $14.86.

Volume traded for the day: 2.92 thousand shares.

Stock performance for year-to-date - up 9.26%

After last Friday's close, Zealand Pharma's market cap was at $423.18 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.4% at the end of the session.


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