DAMIAN is well-positioned to be the industry leader in aldosterone-dependent conditions, with a first-in-class targeted drug and diagnostic therapy for Primary Aldosteronism. DAMIAN is a privately-held Swiss pharmaceutical company led by 3 industry veterans who apply their complementary expertise to deliver therapeutic solutions for aldosterone-dependent conditions.
Primary Aldosterone (PA) is an endocrine disorder with known cause and known negative outcomes, but no targeted therapy.
Dexfadrostat phosphate (DP13), a first-in-class investigational medicine from DAMIAN, directly inhibits aldosterone synthase, the cause of the hormonal imbalance in PA. Following the successful completion of a Phase I study in healthy volunteers, dexfadrostat phosphate was tested in a recently completed Phase II study that evaluated its safety and efficacy in patients with PA.
Dexfadrostat phosphate has the potential to medically control PA and to provide a cost-effective alternative to surgical intervention. The complementary diagnostic tracer, DP14, is in the research phase of development.
For more detailed investor information, please contact us at: info@damianpharma.com
DAMIAN announces publication of phase 2 data of dexfadrostat phosphate in patients with primary aldosteronism
A new open-access publication
DAMIAN announces online publication of the primary data from clinical study DP13C201 in eClinical Medicine, a Lancet journal. The clinical phase 2 study assessed whether dexfadrostat phosphate, a novel aldosterone synthase inhibitor taken orally once a day for 8 weeks, could provide biochemical and clinical benefit in patients with primary aldosteronism (PA) diagnosed, according to the Endocrine Society Clinical Practice Guidelines. The study also evaluated the effect of dexfadrostat phosphate on ambulatory diastolic blood pressure, office systolic and diastolic blood pressure, serum potassium and urinary aldosterone content as well as cortisol levels.
Structural and clinical characterization of CYP11B2 inhibition by dexfadrostat phosphate
A new open-access publication
The final three steps of the biosynthetic pathway of aldosterone are catalyzed by CYP11B2, also known as aldosterone synthase. Hence, inhibiting aldosterone synthase is a targeted mechanism for new therapeutic compounds aimed at reducing aldosterone production. In a new publication by Pignatti et al. the authors reveal that the novel aldosterone synthase inhibitor, dexfadrostat phosphate, aligns with the catalytic moiety of CYP11B2 but not CYP11B1, a related enzyme in the biosynthetic pathway of cortisol. Additionally, both in vitro and clinically, dexfadrostat phosphate demonstrated significant inhibition of CYP11B2 vs. CYP11B1 and did not change basal cortisol levels. Importantly, dexfadrostat phosphate inhibits the final steps in aldosterone biosynthesis, leading to dose-dependent reductions in aldosterone in healthy volunteers.
Pignatti et al., Journal of Steroid Biochemistry and Molecular Biology. 2023; 235.
Doi: 10.1016/j.jsbmb.2023.10640. Online ahead of print.
DAMIAN announces publication in the British Journal of Clinical Pharmacology of phase 1 data of dexfadrostat phosphate in healthy volunteers
Today DAMIAN announces the publication of study DP13C101, a phase 1 study evaluating the efficacy and safety of dexfadrostat phosphate in healthy volunteers in the British Journal of Clinical Pharmacology.
Dexfadrostat phosphate is a novel aldosterone synthase inhibitor (ASI), which acts to directly control the production of aldosterone at its origin. “By inhibiting the 3 enzymatic conversions mediated by aldosterone synthase, dexfadrostat phosphate was shown to demonstrate a dose-dependent reduction of the aldosterone-to-renin ratio (ARR, a marker of sodium retention) without affecting the adrenal stress response or the hypothalamic-pituitary-gonadal axis.”
DAMIAN announced in October 2022 the successful completion of a phase 2 study evaluating dexfadrostat phosphate in patients with primary aldosteronism. The study met both its primary endpoints (ARR, ambulatory systolic blood pressure reduction) with high statistical significance following 8 weeks of once-daily treatment. The study also demonstrated a good safety and tolerability profile.
Mulatero et al., Brit J Clinical Pharmacol. 2023 Mar 13; doi: 10.1111/bcp.15713. Online ahead of print
DAMIAN announces dexfadrostat phosphate achieves high efficacy in PA patients
DAMIAN announces new data from the Phase II trial in patients with primary aldosteronism (PA), that showed the investigational compound dexfadrostat phosphate effectively reduced both aldosterone-to-renin ratio (ARR) and ambulatory systolic blood pressure (aSBP). The trial met both primary endpoints with high significance.
https://dampha.s3.us-east-2.amazonaws.com/assets/uploads/damian-press-release-phase-2-data.pdf
DAMIAN receives research grant from Innosuisse
Innosuisse awards third Swiss research grant to DAMIAN to support the further development of its new research project DP20. The new funding supports a collaboration between DAMIAN and its three research partners: Fachhochschule Nordwest Schweiz, ETH Zurich and the University of Bern.
DAMIAN initiates Phase II study of dexfadrostat phosphate (DP13)
DAMIAN enrolls the first patients in its multinational Phase II study of dexfadrostat phosphate in patients with Primary Aldosteronism (NCT04007406; EUDRACT# 2019-000919-85).
DAMIAN conducts Phase I study of dexfadrostat phosphate (DP13)
DAMIAN executes its Phase I proof-of-concept, double-blind, safety and tolerability study of dexfadrostat phosphate 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 dexfadrostat phosphate (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 dexfadrostat phosphate (DP13). The grant supports the Phase I clinical trial of dexfadrostat phosphate, the first-in-class aldosterone synthase inhibitor from DAMIAN.
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.