Biopharmaceutical company Dauntless Pharmaceuticals Inc reported on Tuesday the receipt of US Food and Drug Administration (FDA) orphan drug designation for DP1038 for the treatment of acromegaly.

The company said acromegaly is most often caused by a benign pituitary adenoma and is characterised by clinical features including enlargement of the hands and feet, facial changes, hypertension, diabetes mellitus and cardiomyopathy.

According to the company, DP1038 is its investigational new drug octreotide acetate for intranasal administration. Octreotide, a somatostatin analog that suppresses excessive growth hormone production from pituitary adenomas, is the mainstay of medical management of acromegaly. DP1038 leverages patented technology for enhanced intranasal absorption and is being developed as a non-injectable octreotide alternative for the treatment of patients with acromegaly.

In conjunction, 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, concluded the company.