In an interview with PharmaShots, Dr. David Kendall, Senior Global Medical Advisor at Zealand Pharma shared his views on the availability of Zegalogue in the US for severe hypoglycemia in pediatric and adult patients with diabetes & its availability in both an auto-injector and a prefilled syringe

Shots:

• The company reported the availability of Zegalogue (0.6mg/0.6mL) in the US for the treatment of severe hypoglycemia in pediatric & adult patients with diabetes aged =6yrs. The therapy is available as both auto-injector & prefilled syringe
• The company has provided a ConnectedCare patient support program to facilitate patient access and offered educational, affordability resources & reimbursement to address the needs of patients & caregivers
• The program included co-pay support for insured patients who may pay $25 for two Zegalogue devices per fill and are eligible for home delivery. On Mar 22, 2021, the therapy had received US FDA's approval for the same indication

Tuba: Tell us about Zealand Pharma. Can you explain what peptide therapeutics are?

Dr. Kendall: Zealand Pharma is a global biotechnology company focused on the discovery, design, development, and commercialization of innovative peptide-based medicines. We have a 20-year history of clinical and basic research and development of peptide therapeutics. We strive to be a leader in specialty medicines focusing on metabolic and gastrointestinal diseases and other rare disease areas with significant unmet medical needs. Our vision is that all patients around the world have access to quality treatments. 

Peptides are naturally occurring biological molecules. Peptides are found in all living organisms and play a key role in all manner of biologic systems. Peptides are short protein molecules formed from a transcription of a sequence of the genetic code, DNA. Transcription is the biological process of copying a specific DNA gene sequence into a messenger molecule, mRNA, which then carries the code for a given peptide or protein. Reading from the mRNA, a chain of amino acids is joined together by peptide bonds to form a single molecule.

Zealand has successfully discovered and developed several novel peptide-based product candidates. This success is based on our deep understanding of peptide chemistry and extensive experience in improving the therapeutic characteristics of naturally occurring peptides by modifying and optimizing their chemical structure. These modifications are designed to improve upon naturally occurring peptides so that they can be optimized for therapeutic use by seeking to provide improved peptide stability and solubility and extend the duration of therapeutic action in hopes of developing a therapy that compares favorably to other treatment options.

Tuba: Zealand received FDA approval for ZEGALOGUE for the treatment of severe hypoglycemia in March and launched the treatment commercially in June 2021. What is unique about ZEGALOGUE and how is it used? How can patients access this new treatment?

Dr. Kendall: ZEGALOGUE was developed to provide a stable, pre-filled rescue therapy for the treatment of severe hypoglycemia (in adults and children aged 6 and above). Minutes matter when dealing with severe hypoglycemia, and studies with ZEGALOGUE demonstrated a median time to blood glucose recovery of 10 minutes across three separate clinical trials. [1]

ZEGALOGUE in both its auto-injector and prefilled syringe presentation - eliminates the need for reconstitution (required with traditional glucagon emergency kits) and following the use of ZEGALOGUE in response to severe hypoglycemia, 99 percent of adult patients in the main phase 3 trial recovered within 15 minutes. In a study of children and adolescents (aged 6 and above) 95 percent of these individuals recovered within 15 minutes. [2]

ZEGALOGUE (dasiglucagon) injection is now commercially available to patients in the US.

Tuba: What does the availability of ZEGALOGUE (dasiglucagon) mean to patients with diabetes?

Dr. Kendall: We believe that the launch of ZEGALOGUE will provide children and adults living with diabetes with another important treatment option to manage very low blood sugar (severe hypoglycemia). ZEGALOGUE is the first and only glucagon analog, and we believe it can play a very important role in helping those with diabetes (and their caregivers) manage the often sudden occurrence of severe hypoglycemia.  

Tuba: Can we have a glance at the data of dasiglucagon presented at ADA 2021?

Dr. Kendall: The company presented six abstracts on dasiglucagon including one oral presentation. These data reinforced the company's commitment to advancing research and development of new treatment options for people living with diabetes who are at risk for and may experience episodes of severe hypoglycemia. 

The data included studies on a rapid recovery across subgroups, predicting true time to recovery from insulin-induced hypoglycemia with dasiglucagon, population pharmacokinetic modeling of dasiglucagon in subjects with type 1 diabetes, data from a 26-week carcinogenicity study, and the reliability and speed of administration with the use of the ZEGALOGUE auto-injector as compared to use of glucagon emergency kit. 

Tuba: Will the company continue to advance scientific development in this space?

Dr. Kendall: Severe hypoglycemia, and recurrent episodes of hypoglycemia, continue to be a significant limiting feature of management for people with diabetes. We at Zealand are committed to helping address this concern and to continue advancing scientific development in this space.

Tuba: Discuss your ConnectedCare patient support program. How does this program help people with diabetes?

Dr. Kendall: Zealand is committed to making a positive difference in the lives of patients with diabetes and ensuring that ZEGALOGUE is available to as many people at risk for severe hypoglycemia as possible. ConnectedCare is a comprehensive patient support program designed to offer affordable resources, reimbursement, and educational support to help address the diverse needs of patients and caregivers. The program includes co-pay support for eligible commercially insured patients who may pay as little as $25 for up to two ZEGALOGUE devices per fill, and the opportunity to receive home prescription delivery. Information on Zealand Pharma ConnectedCare is available at www.zegalogue.com.

Tuba: Are there any digital initiatives in place to engage with Patients & HCPs to increase adherence, show support etc. If not, are there any plans to do so in the future? 

Dr. Kendall: ConnectedCare is a program designed to help patients get access to ZEGALOGUE. By enrolling in ConnectedCare, patients have a myriad of benefits which include: support with insurance coverage, verification of insurance coverage, an automated co-pay savings card for eligible patients, a patient assistance program for eligible patients, and direct shipping to the home at no additional cost.

Tuba: What can the diabetes community expect from Zealand in the next five years?

Dr. Kendall: Zealand is currently working with Beta Bionics on a next-generation artificial pancreas device containing both insulin and dasiglucagon. Leveraging the understanding that insulin and glucagon work in concert, when delivered via a bi-hormonal device and guided by an algorithm, it is designed to maintain and control blood glucose levels while further limiting the need for more patient intervention. The Phase 3 study to test dasiglucagon in the iLet (TM), a bionic pancreas system developed by Beta Bionics, is scheduled to begin later this year.

Tuba: What's next in the Zealand pipeline?

Dr. Kendall: In metabolic diseases, we are also investigating dasiglucagon as a potential treatment option for congenital hyperinsulinism (CHI). Congenital hyperinsulinism is an ultra-rare, yet challenging condition where children experience recurrent episodes of hypoglycemia as a result of the uncontrolled and unregulated release of insulin from their pancreatic beta cells.

References:

1. U. S. National Library of Medicine. (2018, September  2019, September). Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children. Identifier NCT03667053. https://clinicaltrials.gov/ct2/show/NCT03667053
2. U. S. National Library of Medicine. (2016, December  2017, April). ZP4207 (Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon. Identifier NCT02916251. https://clinicaltrials.gov/ct2/show/NCT02916251

Source: Healio

About Author: Dr. David Kendall is a Global Medical Advisor and a senior member of the Global Medical Affairs team at Zealand Pharma. He has graduated from the University of Minnesota Medical School in 1988. He has 35 years of experience in diabetes research, clinical care, education, and pharmaceutical science

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