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

SAN DIEGO, Feb. 16, 2017 /PRNewswire/ -- 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. 

For more information, please see the company website at: www.dauntlessph.com

About Aegis Therapeutics
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 about Aegis, please visit the Aegis website at: www.aegisthera.com

About Sofinnova
Founded in 1974, Sofinnova specializes in clinical and late preclinical investments in biopharmaceutical products. Our goal is to actively partner with entrepreneurs across all stages of company formation including securing initial funding, building successful management teams, forming impactful corporate alliances, and navigating the M&A acquisition or IPOs' process. We seek to build world class companies that aspire to dramatically improve the current state of medical care today and ultimately, the lives of patients. For more information, please visit www.sofinnova.com

About Canaan Partners
Canaan Partners is an early stage venture capital firm that invests in entrepreneurs with visionary ideas.  With $4.2 billion under management, a diversified fund and 190 exits to date, Canaan has invested in some of the world's leading technology and health care companies over the past 30 years. Canaan's focus areas include fintech, enterprise/SaaS, marketplace, e-commerce, biopharma, digital health and medtech.  To learn more about our people and our portfolio, please visit canaan.com.

SOURCE Dauntless Pharmaceuticals, Inc.