DHP has an international Phase IIa clinical trial of DHP-101 underway for systemic sclerosis (NCT04166552) and is in the process of initiating a Phase IIa international clinical trial of DHP-101 for multiple sclerosis.

Enrollment is open for our Phase IIa clinical trial focused on systemic sclerosis with study locations in the United States, Australia and New Zealand. For a list of participating research clinic locations, eligibility criteria and additional study details, visit www.ClinicalTrials.gov. It is important to speak directly with your doctor to determine your eligibility.

Enrollment for our Phase IIa international clinical trial of DHP-101 for the treatment of multiple sclerosis is expected to begin early 2022.

Our medicines initially target four diseases: multiple sclerosis, systemic sclerosis (a severe form of scleroderma), Parkinson’s disease and Huntington’s disease.

DHP-101 is a first-in-class, potentially disease-modifying therapy, initially targeting multiple sclerosis and systemic sclerosis (a severe form of scleroderma). It is a new chemical entity designed with a unique, targeted mechanism of action to address validated disease-related receptors and pathways that may have beneficial impacts on those diseases. DHP-101 has been shown to have anti-inflammatory, anti-oxidative, neuroprotective and immune modulating activities. A Phase IIa clinical trial of DHP-101 in systemic sclerosis patients is currently underway in the United States, Australia and New Zealand. A Phase IIa clinical study is also being initiated in the United States and Australia in multiple sclerosis patients.

DHP-102 is being developed as an oral pharmaceutical product candidate for the treatment of various neurodegenerative diseases. The novel API in DHP-102 (VCE-003.2) has been modified to provide positive effects by positively affecting PPARγ, a key molecular target for the treatment of Huntington’s disease (HD) and Parkinson’s disease (PD), as well as other pathways involved in the pathophysiology of neurodegenerative diseases. These characteristics have led DHP to develop this proprietary new drug candidate initially for HD and PD.

Clinical trials for new treatments are always tested through several steps called phases. The typical phases of clinical trials are:

Phase 1: Safety

Phase 1 focuses on the safety of a drug. It is usually conducted with healthy volunteers with the goal to determine the drug’s most frequent and serious adverse events, at what dose level and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

Phase 2: Safety & Efficacy

A Phase 2 clinical trial is used to gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug’s effectiveness). Participants receiving the drug may be compared to similar participants receiving an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated and short-term adverse events are studied. Usually, fewer than 100 people participate Phase 2 trials.

Phase 3: Safety & Efficacy

Phase 3 gathers more information about a drug’s safety and effectiveness by studying different populations with what would be considered a drug, drug combination, and dosage that might be used in the clinic (i.e. commercially). The drug being studied is compared to a placebo or competitive drug and uses very high standards to ensure the quality of the results – commonly used elements of high-quality clinical study design include being randomized, double-blind, and placebo-controlled. Phase 3 trials may include people from all over the world. The usual number of people in the trial is several hundred to several thousand.

A Phase 3 study is typically undertaken only with expectation that the drug and study design has a good prospect of proving the drug’s clinical utility and being given regulatory and marketing approval by an agency such as the US Food and Drug Administration (FDA).

Phase 4: Additional Research

Phase 4 is sometimes initiated after the FDA has approved a drug for marketing. These trials gather additional information about a drug’s safety, efficacy, or optimal use.

Daggerwing Health Pharmaceuticals is a clinical development stage company. Our Phase IIa clinical trial of DHP-101 in systemic sclerosis patients (a severe form of scleroderma) is currently underway in the United States, Australia and New Zealand.