Bolder BioTechnology has reported positive results from a Phase I clinical trial of BBT-015 in comparison with pegfilgrastim for the treatment of acute radiation syndrome.

BBT-015 is a proprietary long-acting granulocyte colony-stimulating factor (G-CSF) analog, which is currently under development as a treatment for chemotherapy-related neutropenia in cancer patients and for acute radiation syndrome.

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The Phase I trial evaluated the pharmacokinetics, pharmacodynamics, safety and tolerability of single subcutaneous administrations of three different dose levels of BBT-015 and a single dose level of pegfilgrastim.

Altogether, five male subjects were included in each treatment group. The trial was conducted by Celerion and enrolled a total of 15 healthy subjects.

“The positive results are expected to allow BBT-015 to meet the US Food and Drug Administration’s requirement to be used as a treatment of acute radiation syndrome.”

During the trial, all doses of BBT-015 were reportedly well tolerated by all the healthy subjects enrolled for the trial.

According to Bolder, all adverse events credited to BBT-015 were rated as mild, while adverse events of pegfilgrastim were rated as mostly mild and moderate.

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No subjects treated with BBT-015 reported feelings of nauseous or vomiting, which are common side effects of other G-CSF drugs. The subjects did not develop antibodies to BBT-015 or pegfilgrastim.

Bolder BioTechnology president Joe Cox said: “BBT-015 plasma levels were dose-dependent, being highest in subjects receiving the 0.1mg/kg dose; at this dose, mean peak BBT-015 plasma levels were about two-fold higher than mean peak pegfilgrastim plasma levels.

“All BBT-015 doses stimulated long-lasting increases in circulating neutrophils. Mean peak neutrophil levels reached a maximum in subjects treated with 0.04mg/kg and 0.1mg/kg BBT-015, and were higher in these subjects than in subjects treated with 0.1 mg/kg pegfilgrastim.”

The positive results are expected to allow BBT-015 to meet the US Food and Drug Administration’s requirement to be used as a treatment of acute radiation syndrome.