Dauntless Pharmaceutical has announced positive results from a Phase 1 trial of its DP1038 intranasal octreotide acetate, which it is developing for the treatment of acromegaly and neuroendocrine tumors. The company had announced initiation of the trial in February 2017.
The PK/PD trial first compared 3 doses of intranasal octreotide acetate to 100 μg of subcutaneous octreotide acetate in 12 healthy volunteers. According to the company, the study showed a dose proportional PK profile with “significant nasal bioavailability,” and all doses were well tolerated.
In the PD portion of the study, 20 subjects were given a drug to stimulate release of growth hormone, followed by a single dose of DP1038 or 100 μg of subcutaneous octreotide. The company said that suppression of the growth hormone was similar for DP1038 compared to the subcutaneous octreotide.
Dauntless Pharmaceuticals President and CEO Joel Martin commented, “This trial achieved all its endpoints confirming that therapeutic doses of octreotide administered via intranasal delivery are well tolerated and supports our goal of providing patients with the first viable non-invasive option for managing their disease. We look forward to rapidly advancing DP1038 into pivotal studies and subsequently offering patients an efficacious alternative to life-long, painful injections.”
Read the Dauntless Pharmaceuticals press release.
