OUR TREATMENT APPROACH

At DAMIAN, we want to help patients by creating something tangible. We focus our expertise on the diagnosis, localization and treatment of aldosterone-dependent conditions.

Identified in 1956, Primary Aldosteronism is a rare hormonal disorder with no targeted treatment. DAMIAN aims to change that.

The Disease

The adrenal glands help maintain blood pressure and organ perfusion through the controlled secretion of the hormone aldosterone. Primary Aldosteronism (PA) is a disorder that occurs when adrenal production of aldosterone is no longer controlled. This overproduction of aldosterone leads to water and sodium retention and potassium loss. This can result in irreversible structural damage to the blood vessels and manifest as chronic high blood pressure. Untreated, PA can lead to an increased risk of stroke, myocardial infarction, and chronic kidney disease.

DP13: Our Investigational Drug

An aldosterone synthase inhibitor, DP13 is a first-of-its-kind treatment for PA that medically targets the cause of the disease. DAMIAN successfully completed its Phase I Clinical Trial evaluating the pharmacological properties of DP13 in healthy volunteers. The safety and efficacy of DP13 is currently being investigated across Europe in patients with PA in a Phase II Trial.

Currently available therapies have no impact on the cause of PA i.e., the overproduction of aldosterone. In contrast, DP13 selectively inhibits the enzyme responsible for aldosterone production, thus directly reducing the amount of aldosterone in the body. 

DP14: Our Diagnostic Tool

The diagnostic pathway for PA is complex, requiring specialist expertise, particularly the detection of a unilateral tumor which is not always successful. The introduction of DP14, a unique PET tracer currently in the research phase, has the potential to image and localize aldosterone-producing benign tumors without the need for specialist surgery and with a higher success rate. 

Future Directions

DAMIAN is committed to helping patients by finding treatment solutions wherever they exist. Remaining true to its mission, DAMIAN continues to identify and evaluate additional therapeutic opportunities or diagnostic solutions in other aldosterone-dependent conditions.

It’s not like we are searching for something theoretical. We are convinced something is there. We just need to go and prove it.

Paolo Mulatero

Professor of Internal Medicine, University of Torino, Italy

PA Expert and DP13C201 Principal Investigator

DAMIAN Product Timeline

  • 2020

    DAMIAN initiates Phase II study of DP13 

    DAMIAN enrolls the first patients in its multinational Phase II study of DP13 in patients with Primary Aldosteronism (NCT04007406; EUDRACT# 2019-000919-85).

  • DAMIAN conducts Phase I study of DP13 

    DAMIAN executes its Phase I proof-of-concept, double-blind, safety and tolerability study of DP13 in healthy volunteers (NCT03046589). The Phase I study successfully completed in September 2018.

  • Pre-Investigational New Drug (IND) meeting with FDA

    The full clinical development plan for DP13 in Primary Aldosteronism was discussed with FDA in a Pre-IND meeting, including advice on Phase III design and registration endpoints. 

  • DAMIAN receives grant from the Swiss Commission for Technology and Innovation

    The Swiss Commission for Technology and Innovation (CTI) awarded DAMIAN with a grant to support the DP14 diagnostic tracer project. The Commission promotes science-based innovation in the interests of industry and society in Switzerland. Funding allocation is based on competitive applications and allows small companies the ability to work with research partners to test and develop their ideas.

  • DAMIAN clinical plan affirmed by the Foundation for Therapeutic Research

    The Lausanne-based Foundation for Therapeutic Research awards a grant for the development of new therapeutic principles in cardiovascular disease to the University of Torino to investigate DP13. The grant supports the Phase I clinical trial of DP13, the first-in-class aldosterone synthase inhibitor from DAMIAN.

  • 2015

    DAMIAN incorporated in Switzerland

    In 2015, DAMIAN was incorporated in Zug, Switzerland with the goal to deliver a targeted medicine to patients with Primary Aldosteronism. Subsequently, the mission of DAMIAN was expanded to find treatment solutions for aldosterone-dependent conditions, wherever they exist.