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Immunotherapy treatment for type 1 diabetes granted orphan drug status

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DV-0100, a drug tested for treatment of type 1 diabetes, has been given FDA approval for orphan drug status, according to the drug’s manufacturer.

“The granting of this orphan drug designation represents a key milestone for the company,” Haro Hartounian, PhD, CEO of DiaVacs, said in a press release. “We are excited by the promise that DV-0100 showed in our phase 1 clinical trial and look forward to assessing its therapeutic potential in the ongoing phase 2 clinical trial for this indication.”

According to the press release, DV-0100 inhibits a patient’s autoimmune reaction to pancreatic islet cells, which are responsible for producing insulin. The technology uses dendritic cells from the patient modified via small interfering oligonucleotides; these cells are used to “vaccinate” the patient and induce insulin tolerance.

The company said the drug was effective in a phase 1 human trial, producing endogenous insulin for up to 10 years, and the FDA has approved the initiation of a phase 2 trial, according to the press release.

Orphan designation qualifies DV-0100 for 7 years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for this product in type 1 diabetes.