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Zealand Pharma Announces Positive Results from Phase 3 Trial of Dasiglucagon in Pediatric Patients with Congenital Hyperinsulinism (CHI)

• Dasiglucagon met the primary endpoint with statistical significance - reducing the requirement for intravenous glucose by 55% compared to placebo in this pediatric patient population (ages 7 days to 12 months) when compared to placebo.
• Dasiglucagon treatment was assessed as well-tolerated in this study and 11 out of 12 patients are continuing into the long-term safety extension study.
• These data, together with data from a previously reported Phase 3 study in older children with CHI, are expected to form the basis of a new drug application (NDA) for dasiglucagon treatment in the management of CHI, with the U.S. Food and Drug Administration. Submission is anticipated by end of 2022.

Copenhagen, DK and Boston, MA, U.S. May 19, 2022 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078,) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced positive top-line results from its second Phase 3 clinical trial of dasiglucagon in pediatric patients with congenital hyperinsulinism (CHI). The Phase 3 program for dasiglucagon constitutes the largest clinical development program ever conducted in CHI.

READ THE FULL ARTICLE FROM GLOBE NEWSWIRE

BOSTON, May 27, 2022 (GLOBE NEWSWIRE) -- Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, today announced it is presenting a poster on the AMPLIFY-201 study design at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting, being held in-person from June 3-7, 2022, in Chicago. AMPLIFY-201 is a Phase 1 study evaluating the safety and efficacy of ELI-002, a lymph node-targeted therapeutic cancer vaccine, as a treatment for patients with mKRAS-driven tumors who have minimal residual tumor cells following surgery to remove the tumor.

Full PRESS RELEASE

By Olivia Trani, Oak Ridge National Laboratory---

One group of peptides, known as antimicrobial peptides (AMPs), serves as an innate line of defense against microbial diseases in animals, plants, and other multicellular organisms. Given their ability to quickly identify and take down a wide range of pathogens, these peptides are considered promising therapeutic candidates for treating bacterial infections where antibiotics have fallen short.

Neutron experiments led by scientists from the Department of Energy's (DOE's) Oak Ridge National Laboratory (ORNL) have produced new details into how AMPs block bacterial infections. By studying an effective AMP called aurein 1.2, the team pieced together the molecular mechanics behind the peptide's ability to deal significant damage to bacterial cells in small quantities. Their findings, published in BBA Advances, could help pharmaceutical experts develop drugs that attack antibiotic-resistant bacteria more efficiently and effectively.

Full article available at Phys.org

After a year of slumping stock prices, Zealand Pharma is striking back, as its peptide drug improved blood sugar control in infants with the rare disease congenital hyperinsulinemia in a phase III trial. 

In late 2020, the Danish firm Zealand Pharma A/S hit a big obstacle when its peptide drug dasiglucagon failed to treat the rare condition congenital hyperinsulinism (CHI) in a phase III trial. The company’s stock price dropped by 10% in reaction to the news, and only continued downwards the following year as massive volatility struck biotech stocks around the world.

To read the full article visit Labiotech.eu