FDA Grants Orphan Drug Designation to Dauntless Pharma's DP1038 for the Treatment of Acromegaly

 Dauntless Pharmaceuticals, a privately held biopharmaceutical company focused on the development of specialty therapeutics announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DP1038, the company's investigational new drug, octreotide acetate for intranasal administration, for the treatment of acromegaly.

Acromegaly is most often caused by a benign pituitary adenoma and is characterized by clinical features including enlargement of the hands and feet, facial changes, hypertension, diabetes mellitus and cardiomyopathy. Octreotide, a somatostatin analog that suppresses excessive growth hormone production from pituitary adenomas, is the mainstay of medical management of acromegaly.

"The FDA's decision to grant DP1038 orphan drug designation for the treatment of acromegaly is an important milestone in our program as we strive to bring patients a non-injectable alternative for the management of their disease," said Joel Martin, Ph.D., President and Chief Executive Officer. "Granting of the designation highlights the unmet medical need for a new therapy that may transform the lives of these patients."

The FDA grants orphan drug status to promote the development of novel products to treat conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides significant benefits to the sponsor, including seven years of market exclusivity following marketing approval, tax credits for clinical research costs, eligibility for Orphan Product grants and the waiver of certain administrative fees.

About DP1038

DP1038 leverages patented technology for enhanced intranasal absorption developed by Aegis Therapeutics, LLC, and is being developed as a non-injectable octreotide alternative for the treatment of patients with acromegaly. As previously reported, DP1038 demonstrated an excellent safety and pharmacokinetic profile as well as on-target pharmacological effects in a Phase 1 clinical study that assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers. The somatostatin analog market currently exceeds $2 billion annually with all commercially available formulations requiring subcutaneous or intramuscular injections.

About Dauntless

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.