UPDATED: Zealand takes PhII data to FDA after going up against Novo’s incumbent

FDA sign

Zealand Pharma (CPH:GEN) is preparing to discuss the future of its hypoglycemia drug with the FDA after pitting the rescue pen against Novo Nordisk’s ($NVO) GlucaGen in Phase II. The data suggest Zealand’s pen achieves clinically relevant increases in plasma glucose in comparable times to GlucaGen, but, notably, its longer shelf life supports ready-to-use formulations.

Copenhagen, Denmark-based Zealand enrolled 81 Type 1 diabetics in the study and gave them single doses of ZP4207, its glucagon peptide analog, or Novo’s GlucaGen following an insulin-induced hypoglycemic event. The trial assessed a variety of pharmacodynamic and pharmacokinetic endpoints, such as time to peak plasma glucose concentration. From the limited, selected look at the data shared by Zealand in its release, ZP4207 held its own against GlucaGen.

The three highest doses of ZP4207 triggered blood glucose concentrations of 70 mg/dl or more in the 30 minutes following administration. GlucaGen also hit this target. ZP4207 matched up to GlucaGen in terms of the time it took to increase plasma glucose to 20 mg/dl, a level Zealand views as being clinically relevant. Taking the median of the dataset, the experimental therapy and GlucaGen both drove plasma levels up past 20 mg/dl in 9 to 10 minutes. Safety was similarly comparable.

That is all the information Zealand has released for now. Zealand intends to publish the full Phase II data in the future but, as it stands, is yet to share details of how ZP4207 performed against the majority of the 15 PK/PD outcome measures assessed in the trial, including all of those designated as primary in the protocol. Zealand SVP Hanne Leth Hillman told FierceBiotech how the outcomes came to be selected for inclusion in the top-line release.  

"We have chosen to inform of the outcome on those of them that we consider to have main clinical relevance for the therapeutic potential of our analog in a hypoglycemia rescue setting, and save information on the outcome on all other parameters until we have analyzed the full Phase II data set and discussed them with the FDA," Hillman said.

Zealand, which has been upfront about negative data in the past, thinks the results add to evidence of the attractive profile of ZP4207. Armed with the data, Zealand now plans to talk to FDA to define how to take ZP4207 forward, a process it sees leading to Type 1 diabetics gaining access to a more convenient way to treat severe hypoglycemia.

“With the current results we believe to be one step closer to being able to offer insulin dependent diabetes patients a ready-to-use pen for convenient and fast rescue from severe hypoglycemia--or insulin shock,” Zealand Chief Development and Medical Officer Adam Steensberg said in a statement. “We see a clear need for a patient friendly rescue product and we look forward to the next step in development.”

The appeal of ZP4207, which is now also known as dasiglucagon, lies in its shelf life. GlucaGen is sold as a powder, a form that means it must be dissolved in an accompanying solvent prior to administration. By creating a glucagon peptide analog stable enough to be kept in a liquid solution, Zealand thinks it can provide diabetics with a rescue pen that is ready to use. The drug is also central to the artificial pancreas Zealand is working on with Beta Bionics.

Following the failure of its cardiac reperfusion injury drug in Phase II earlier this year, ZP4207 is the most advanced candidate in Zealand’s in-house pipeline. The company is best known for its alliance with Sanofi ($SNY), in particular the GLP-1 peptide agonist Adlyxin.

- read the release

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