Dauntless Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Octreotide Formulation for Intranasal Delivery

SAN DIEGO, CA, USA I February 16, 2017 I Dauntless Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of specialty therapeutics, today announced the initiation of a Phase 1 clinical study 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.

"We are committed to providing an improved treatment option for patients who rely on octreotide therapy to manage their disease," said Joel Martin, PhD, President and Chief Executive Officer of Dauntless Pharmaceuticals.  "DP1038 provides a non-invasive delivery designed to eliminate painful injections, provide dosing flexibility, and reduce side effects that lead to diminished quality of life."

Dauntless Pharmaceuticals recently closed a $25 million expansion of its Series A financing, led by Canaan Partners with participation from Sofinnova. As part of the recent financing, Nina Kjellson, partner of Canaan Partners, has joined the Board of Directors.  She joins Joel Martin, PhD, David Kabakoff, PhD, Sofinnova executive partner, and Michael Powell, PhD, Sofinnova general partner, co-founder and chairman on the company's board of directors.

About DP1038
DP1038 (octreotide acetate for intranasal administration) is being developed via the 505(b)(2) regulatory pathway for the treatment of acromegaly and neuroendocrine tumors.  DP1038 leverages patented technology for enhanced intranasal absorption developed by Aegis Therapeutics, LLC, a drug delivery and drug formulation company that has successfully licensed its technology to leading pharmaceutical and biopharmaceutical companies whose partners have multiple late stage clinical programs under development. 

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, and of serotonin and other hormones by tumors of the neuroendocrine system.  In 2015, worldwide sales of somatostatin analogs exceeded $1.6 billion.

About Dauntless Pharmaceuticals, Inc.
Dauntless Pharmaceuticals, Inc. develops specialty pharmaceutical drugs 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.

Dauntless Pharmaceuticals, started in 2015, has raised committed capital of $32 million from its founding investor, Sofinnova, along with Canaan Partners who led the most recent financing.  The funds are dedicated to the advancement of the first asset, DP1038, and an undisclosed second asset.

SOURCE: Dauntless Pharmaceuticals

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