SAN DIEGO, May 4, 2017 /PRNewswire/ -- Dauntless Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of specialty therapeutics, today announced positive results from its two-part, Phase 1 pharmacokinetic/pharmacodynamic study evaluating DP1038, a novel formulation of octreotide acetate for intranasal administration.
"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," said Joel Martin, Ph.D., President and Chief Executive Officer of Dauntless Pharmaceuticals. "We look forward to rapidly advancing DP1038 into pivotal studies and subsequently offering patients an efficacious alternative to life-long, painful injections."
About the Phase 1 Trial
The Phase 1 trial was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DP1038, a novel formulation of octreotide acetate for intranasal administration, compared to subcutaneous Sandostatin® (octreotide acetate) Injection in healthy volunteers. In Part 1 of the study, each of 12 subjects received three doses of DP1038 plus 100 micrograms of subcutaneous octreotide acetate in a randomized 4 x 4 Latin square design. DP1038 was well tolerated across all doses and demonstrated a consistent, dose proportional pharmacokinetic profile with significant nasal bioavailability. In Part 2 of the study, a single dose of DP1038, which was selected to exhibit a similar pharmacokinetic profile to subcutaneous octreotide acetate, was evaluated in 20 subjects in a cross-over design to compare the pharmacodynamic effect to 100 micrograms of subcutaneous octreotide acetate. Subjects were given a GHRH-arginine challenge, a standard test to stimulate growth hormone release, followed by administration of DP1038 or subcutaneous octreotide acetate. DP1038 showed comparable growth hormone suppression to the subcutaneous reference product.
Additional information on the design of the trial can be found at www.clinicaltrials.gov.
Octreotide is a synthetic peptide analog of naturally occurring somatostatin, with similar pharmacological effects but longer duration of action. It inhibits the secretion of growth hormone from pituitary adenomas for the treatment of acromegaly, and of serotonin and other hormones in the treatment of neuroendocrine tumors (NETs), both orphan populations. In 2016, worldwide sales of somatostatin analogs exceeded $ 2 billion.
DP1038 leverages patented Intravail® technology developed by Aegis Therapeutics LLC for enhanced intranasal absorption. DP1038 (octreotide acetate for intranasal administration) is being developed via the 505(b)(2) regulatory pathway for the treatment of acromegaly and neuroendocrine tumors.
About Dauntless Pharmaceuticals, Inc.
Dauntless Pharmaceuticals, Inc. develops specialty therapeutics via a one-asset, one-company model that is structured to facilitate operational efficiencies. Dauntless 1, its first asset company, was formed to develop DP1038, a therapeutic agent for the treatment of acromegaly and neuroendocrine tumors. Launched in 2015, Dauntless Pharmaceuticals has raised committed capital of $32 million from Sofinnova and Canaan Partners. For more information, please see www.dauntlessph.com.
About Aegis Therapeutics LLC
Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Its Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Its ProTek® excipients stabilize, prevent aggregation and reduce unwanted immunogenicity and anaphylaxis of protein and peptide therapeutics while avoiding the oxidative damage caused by polysorbate surfactants currently found in most protein injectable drugs. For more information, please visit www.aegisthera.com.
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SOURCE Dauntless Pharmaceuticals, Inc.