ARTICLE | Clinical News

Zealand's glepaglutide meets in Phase II for SBS

July 28, 2017 9:03 PM UTC

Zealand Pharma A/S (CSE:ZEAL) reported data from a Phase II trial in 16 patients with short bowel syndrome (SBS) showing that once-daily subcutaneous glepaglutide (ZP1848) met the primary endpoint of reducing fecal wet weight output at 3 weeks compared to baseline. Specifically, 1 and 10 mg doses of glepaglutide reduced wet weight of ostomy output or diarrhea at 3 weeks compared to baseline by 593 (23%, p=0.0021) and 833 (30%, p=0.0002) grams/day, respectively. On a secondary endpoint, glepaglutide significantly increased energy absorption compared to baseline for the combined 1 and 10 mg dose groups (p<0.05).

Glepaglutide was well tolerated with nausea, abdominal pain, abdominal distension, vomiting, stoma complications, dizziness, polyuria, reduced appetite, peripheral edema, cough and injection-site reactions reported as the most common adverse events. The double-blind, crossover, Danish trial evaluated once-daily 0.1, 1 and 10 mg doses of glepaglutide given by an injectable pen device in 3-week treatment periods. Each patient received 2 different doses of glepaglutide separated by a 4-week washout period. Other secondary endpoints in the trial include changes in urine output and absorption of electrolytes and macronutrients, safety and pharmacokinetics...

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Zealand Pharma A/S