PIPELINE

By dedicating an independent company to each asset, Dauntless offers a faster and more capital efficient way to advance clinical candidates. Each company has the benefit of Dauntless’ expertise across the drug development continuum.

Asset Company Pre-Clinical Clinical Development
Formulations POC Toxicology Safety Proof-of-Concept Pivotal
DP2018

Octreotide Depot
acromegaly/NETs
DP1038

DP1038 Intranasal Octreotide
acromegaly / neuroendocrine tumors / CID
Dauntless 3

Coming Soon
Asset Company Phase
DP1038
DP1038 Intranasal Octreotide		 Proof-of-Concept
DP2018
DP2018 Undisclosed Asset		 Pre-Clinical
Dauntless 3
Coming Soon

DP2018

DP2018 is a novel microsphere octreotide depot based on proprietary technology. As compared to traditional microsphere formulations, Dauntless has developed small, homogeneous microspheres with low burst and zero-order release. These technological improvements enable higher drug loading and the ability to deliver via fine-gauge needles.

Dauntless Octreotide Microparticles are Small, Uniform and Syringeable via Smaller Needles

dp2018
dp2018

Dauntless’ lead depot program, DP2018 is in preclinical development with an IND filing expected in early 2019. The novel depot formulation is being developed as a weekly or biweekly subcutaneous injection for self administration.

Preclinical Rabbit Drug Release Profile: Dramatically Better PK and Smaller Injection Volumes

dp2018 preclinical

DP2018 Single Dose PK in 25 kg Minipigs Supports Target Product Profile

dp2018 circulating octreotide concentration

DP 1038

Download DP1038 Poster

Developing a non-injectable somatostatin analog alternative for patients. DP1038 is a short-acting octreotide formulation delivered as a nasal mist that is not inhaled.

DP 1038 is available for licensing/partnering. Please contact info@dauntlessph.com.

Octreotide, a somatostatin analog, is an inhibitor of growth hormone that is administered solely by injection in approved products, and is used as first-line pharmacotherapy for two orphan diseases, acromegaly and neuroendocrine tumors, with utility in several gastrointestinal disorders including chemotherapy-induced diarrhea (CID).

The current market for somatostatin analogs exceeds $2 billion and is dominated by products that are administered by health care professionals. Limitations of long-acting somatostatin analogs include painful injection site reactions and nodules from very large injection volumes and needles, and breakthrough symptoms when octreotide levels are too low to adequately treat the patient.

DP1038 is being developed for patients who desire a non-invasive alternative or who are not adequately controlled on long-acting formulations and can benefit from short-acting pharmacotherapy.

DP1038 leverages patented Intravail® technology developed by Aegis Therapeutics LLC for enhanced intranasal absorption.

Dauntless 3

Coming soon…