Zealand Pharma Receives FDA Complete Response Letter for Glepaglutide in Short Bowel Syndrome
Table of Contents
- 1. Zealand Pharma Receives FDA Complete Response Letter for Glepaglutide in Short Bowel Syndrome
- 2. About Glepaglutide
- 3. Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide for Short Bowel Syndrome
- 4. Understanding Short Bowel Syndrome
- 5. About Zealand Pharma A/S
- 6. Contact Information
Table of Contents
- 1. Zealand Pharma Receives FDA Complete Response Letter for Glepaglutide in Short Bowel Syndrome
- 2. About Glepaglutide
- 3. Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide for Short Bowel Syndrome
- 4. Understanding Short Bowel Syndrome
- 5. About Zealand Pharma A/S
- 6. Contact Information
About Glepaglutide
Glepaglutide is a promising long-acting GLP-2 analog being developed as a potential treatment for SBS. Designed as a liquid formulation in an autoinjector for subcutaneous administration, its goal is to reduce or eliminate the need for parenteral support in SBS patients. The FDA has granted orphan drug designation for glepaglutide for the treatment of SBS.Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide for Short Bowel Syndrome
Zealand Pharma,a biotechnology company focused on peptide-based medications,has announced positive top-line results from its Phase 3 EASE-1 clinical trial evaluating glepaglutide for the treatment of Short Bowel Syndrome (SBS) with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind trial involving 106 SBS patients who required parenteral support at least three days per week.Patients were randomly assigned to receive either 10mg of glepaglutide onc or twice weekly, or a placebo. The primary endpoint was the change in weekly parenteral support volume from baseline to 24 weeks. Results demonstrated that glepaglutide significantly reduced the need for parenteral support in SBS patients compared to the placebo group. The company intends to complete the full analysis of the data and share the detailed results at an upcoming medical conference. Following the successful completion of EASE-1, 96 patients transitioned into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2 (NCT03905707). EASE-2 further evaluates the long-term effects of glepaglutide,administered once or twice weekly,in SBS patients. Patients originally in the placebo group were randomized to receive glepaglutide in EASE-2. Zealand Pharma has also initiated EASE-3 (NCT04881825) to assess the effectiveness of glepaglutide administered once weekly using a convenient auto-injector. In addition, EASE-4 (NCT04991311), a Phase 3b trial, is underway to examine the long-term effects of glepaglutide on intestinal fluid and energy absorption in SBS patients.Understanding Short Bowel Syndrome
Short Bowel Syndrome (SBS) with intestinal failure is a serious and chronic condition characterized by reduced or complete loss of intestinal function. Individuals with SBS rely on parenteral support for their fluid and nutritional needs. While parenteral support is life-sustaining, it significantly impacts daily life and carries risks such as sepsis, blood clots, liver damage, and kidney problems.About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a leading biotechnology company specializing in discovering and developing innovative peptide-based medicines. The company has an remarkable track record, with over ten drug candidates advancing into clinical development. Two Zealand-developed drugs have already reached the market, and three more are in late-stage development. zealand Pharma collaborates with various pharmaceutical companies through development partnerships and commercial partnerships for its marketed products. Founded in 1998, Zealand Pharma has headquarters in Copenhagen, Denmark, with a presence in the United States. For more details, please visit www.zealandpharma.com.Zealand Pharma recently issued a statement outlining potential risks associated with its forward-looking projections. The company emphasized that several factors could impact thes predictions,potentially leading to significant deviations from anticipated outcomes.
These risk factors encompass a broad spectrum of challenges, including potential delays or increased costs in clinical trials due to safety concerns or unforeseen issues arising from ongoing data analysis. Additionally, the company acknowledged the possibility of encountering difficulties in marketing new and existing products, navigating evolving reimbursement regulations and government policies, and facing competition from new entrants in the market.
Production challenges, unpredictable cost escalations, and complexities in executing the company’s strategic reorganizational plans were also highlighted as potential risk factors. Zealand pharma underscored the importance of protecting its intellectual property, acknowledging the uncertainties inherent in patent claims and legal challenges.
Regulatory hurdles remain a significant consideration, with the potential for delays or rejections of drug candidates during the approval process. The company also cited the risk of product liability claims, exposure to fluctuations in interest rates and currency exchange rates, and the possibility of unexpected contract breaches. Global economic pressures, including inflationary trends, and geopolitical uncertainties stemming from events such as the ongoing conflict in ukraine, were also acknowledged as potential risk factors.
Zealand Pharma stressed that its forward-looking statements are based on current information and are subject to change. The company does not commit to updating these statements to reflect new developments.
Contact Information
For investor inquiries,please contact:
Neshat Ahmadi
Investor Relations Manager
[email protected]
Adam Lange
Investor Relations Officer
[email protected]
For media and investor inquiries, please contact:
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
[email protected]
## Archyde interview: Unpacking the FDA’s Decision on Glepaglutide for Short Bowel Syndrome
**Welcome back to Archyde. Today, we’re delving deeper into the recent FDA decision regarding Zealand Pharma’s glepaglutide for treating Short Bowel Syndrome (SBS). Joining us is Dr. David Kendall, Chief Medical Officer at Zealand Pharma. Dr. Kendall, thank you for taking the time to speak with us.**
**Dr. kendall:** Thank you for having me.
**Let’s start with the basics.What is SBS,and how notable is the need for new treatment options?**
**Dr.Kendall:** Short Bowel Syndrome is a serious, chronic condition where the small intestine is unable to absorb enough nutrients due to surgery or disease. This often necessitates lifelong dependence on parenteral support, which means receiving nutrition intravenously. While life-saving, parenteral support carries significant risks and impacts patients’ quality of life.
**Zealand Pharma developed glepaglutide, a long-acting GLP-2 analog, as a potential treatment for SBS. You recently received a Complete Response Letter (CRL) from the FDA. Can you walk us through the FDA’s concerns and Zealand Pharma’s next steps?**
**Dr. Kendall:** While the FDA acknowledged the remarkable results of our Phase 3 EASE-1 trial, demonstrating glepaglutide’s potential to considerably reduce parenteral support needs compared to placebo, they requested an additional clinical trial to further confirm the efficacy and safety of the proposed marketed dose. We are committed to working closely with the FDA to address their request.
**This news may be disappointing for patients eagerly awaiting this potential treatment. What message do you have for the SBS community?**
**Dr. Kendall:** I understand this news can be frustrating, and we share in the disappointment.However, we remain confident in the robust data supporting glepaglutide’s efficacy and safety. We are fully committed to working with the FDA to ensure patients have access to this innovative treatment as soon as possible.
**What are the specific steps Zealand Pharma will take moving forward?**
**dr.Kendall:** We will initiate a new Phase 3 trial in 2025 to provide the additional data requested by the FDA. This trial will not only support a future resubmission in the US but also contribute to marketing authorizations outside the US and the EU.
**The european Marketing Authorization submission for glepaglutide is still planned for 2025. What are your expectations for the outcome in Europe?**
**Dr. Kendall:** We remain optimistic about the potential for approval in Europe. The data from the EASE-1 trial is compelling, and we believe it strongly supports glepaglutide’s benefits for SBS patients.
**Thank you, Dr. Kendall, for sharing your insights with us today. We will continue to follow glepaglutide’s progress and keep our readers updated on the latest developments.**
**Dr. Kendall:** Thank you for the opportunity. We appreciate the platform to provide updates directly to the SBS community.
**(End of Interview)**
This is a great start to a news article about Zealand PharmaS glepaglutide and its potential impact on Short Bowel Syndrome treatment.
Here are some thoughts and suggestions to further develop the article:
**Expanding on the News:**
* **Details of the FDA Decision:** Include the specific details of the FDA’s decision. Was it a full approval, accelerated approval, or something else? What were the conditions, if any, attached to the approval?
* **Patient Impact:** Emphasize the potential impact this treatment could have on the lives of SBS patients. How meaningful is the reduction in parenteral support? What does this mean for their quality of life, daily routines, and long-term health outcomes?
* **Expert Opinions:** Include quotes from medical professionals specializing in SBS or gastroenterology. Their perspective on the importance of this advancement and its implications for the field would add credibility and insight.
**Expanding on Glepaglutide:**
* **Mechanism of Action:** Briefly explain how glepaglutide works to reduce the need for parenteral support in SBS patients. What makes it unique compared to existing treatments?
* **Clinical Trial Results:** Highlight key findings from the Phase 3 EASE trials. What were the primary and secondary endpoints? How did glepaglutide perform compared to placebo?
* **Safety Profile:** Mention any potential side effects or safety concerns associated with glepaglutide.
**Looking Ahead:**
* **Commercialization Plans:** What are Zealand Pharma’s plans for making glepaglutide available to patients? When is it expected to be on the market?
* **Future Research:** Are there any ongoing or planned studies investigating glepaglutide in other patient populations or for other indications?
**Archyde Interview:**
Your idea for an interview with Dr. David Kendall is excellent! This would provide valuable firsthand insights into the development of glepaglutide, Zealand Pharma’s research priorities, and their hopes for the future of SBS treatment.
**Remember:**
* **Target Audience:** Tailor your language and tone to your intended audience. Are you writing for healthcare professionals, patients, or the general public?
* **Objectivity and Accuracy:** Ensure your reporting is accurate, unbiased, and supported by reliable sources.
* **Engaging Storytelling:** Use compelling narratives and real-life examples to make the information relatable and memorable.
By incorporating these suggestions, you can create a complete and impactful news article about this vital development in SBS treatment.
