After a yr of slumping inventory costs, Zealand Pharma is putting again, as its peptide drug improved blood sugar management in infants with the uncommon illness congenital hyperinsulinemia in a part III trial.
In late 2020, the Danish agency Zealand Pharma A/S hit a giant impediment when its peptide drug dasiglucagon did not deal with the uncommon situation congenital hyperinsulinism (CHI) in a part III trial. The corporate’s inventory worth dropped by 10% in response to the information, and solely continued downwards the next yr as huge volatility struck biotech shares around the globe.
Even the FDA approval of dasiglucagon for the remedy of low blood sugar ranges in diabetes in Might 2021 did not reverse Zealand Pharma’s woes. Earlier this yr, the corporate revealed slower gross sales expectations of the product than it had hoped and made massive layoffs in its US operation.
This week, nonetheless, issues took a optimistic flip for the agency, as dasiglucagon met the aim of a second part III trial treating youngsters in hospital with CHI. Delivered beneath the pores and skin through a steady pump, the remedy greater than halved the glucose that wanted to be given to the sufferers intravenously to manage their blood sugar ranges in comparison with a placebo. As well as, 11 of the 12 recruited sufferers will proceed to a long-term security extension research. Zealand Pharma’s inventory worth rose by nearly 20% in response to the announcement.
Zealand Pharma’s president and CEO, Adam Steensberg, welcomed the outcomes. “CHI is a severe ultra-rare situation with a big unmet medical want which locations an amazing burden on each sufferers and households,” stated Steensberg in a public assertion.
“We consider the result of this trial helps the potential of dasiglucagon as a novel remedy for these dwelling with CHI. We sit up for participating with the US FDA and shifting ahead with our New Drug Software.”
CHI happens when a genetic mutation causes cells within the pancreas referred to as beta cells to supply an excessive amount of insulin, a hormone that lowers blood glucose ranges. This may result in dangerously low blood sugar ranges, which may critically endanger the life and growth of youngsters with the situation. Hospitals can ship glucose intravenously to extend blood sugar ranges, however this strategy is tedious and may’t be carried out at house. For greater than three many years, the one FDA-approved remedy for CHI has been diazoxide, which may’t profit all sufferers and may trigger unwanted effects together with nausea and excessive blood sugar.
“As with many different uncommon illnesses, CHI solely lately began to get consideration from the business,” Steensberg advised us by electronic mail.
Zealand Pharma’s dasiglucagon is an analog of the peptide hormone glucagon, which raises blood sugar ranges. Dasiglucagon is designed to be secure sufficient to be delivered repeatedly through a subcutaneous pump, which might enhance the management of blood sugar ranges at house and decrease the necessity for intensive hospital care in CHI. Moreover, it might delay the necessity to take away components of the pancreas, which is a drastic intervention in CHI.
“Earlier makes an attempt from different firms to design such secure analogs of glucagon have failed, which can additionally to some extent clarify the shortage of latest medicines for this indication,” defined Steensberg. “Subcutaneous infusion is necessary as intravenous infusions can solely be accomplished in a hospital setting.”
The primary CHI part III trial the place dasiglucagon failed recruited 32 sufferers aged from three months to 12 years of age, and that have been affected by greater than three hypoglycemic occasions per week regardless of being closely handled. Including dasiglucagon to the usual of care didn’t present any important advantages over common remedy when the sufferers measured their very own glucose ranges. Nevertheless, in a secondary measure, Zealand Pharma noticed a robust impact within the first trial when it measured glucose ranges through blinded steady monitoring.
Within the second CHI trial, Zealand Pharma recruited a lot youthful youngsters from seven days to 12 months of age in a hospital setting.
Zealand Pharma specializes within the supply of remedies to manage blood sugar in situations corresponding to CGI and diabetes. In early 2020, Zealand Pharma took over the stricken agency Valeritas Holdings Inc. and acquired maintain of Valeritas’ V-Go Wearable Insulin Supply system, which is marketed to enhance the management of blood sugar in sort 2 diabetes. Earlier this week, Zealand Pharma offered the V-Go system to MannKind Company for $10M along with sales-based milestone funds.
In a partnership with Beta Bionics, Zealand Pharma can be growing dasiglucagon as a part of a man-made pancreas insulin pump, a type of know-how that would sooner or later enable diabetes sufferers to handle their blood sugar utterly routinely. The agency can be operating packages to deal with weight problems, nonalcoholic steatohepatitis (NASH), and inflammatory illnesses.
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