SynDermix AG announced temporary postponement of initiation of the SDX-3101 clinical trial on chronic rhinosinusitis without nasal polyps due to the novel coronavirus pandemic.
HÜNENBERG, ZUG – 7 April, 2020
SynDermix AG announced today that, following a thorough evaluation of the possible impact of the COVID-19 outbreak on its clinical development and to ensure the safety of the stakeholders involved, the Company has decided to temporarily postpone the initiation of patient enrolment in the clinical trial of SDX-3101 — a novel, drug-free and non-invasive portable medical device for the treatment of patients with chronic rhinosinusitis without nasal polyps (CRSsNP).
SynDermix has been monitoring the COVID-19 outbreak since January 2020, which has rapidly become a pandemic severely burdening healthcare systems in many countries, with an especially high incidence in those participating in the SDX-3101 clinical trial. As the pandemic has disrupted clinical research and restricted access to hospitals for external study staff, SynDermix AG has followed the guidance of the public health authorities and paused its clinical trial plans until further notice.
“This postponement of the SDX-3101 clinical trial is a necessary decision during these difficult times.” said Mr Dieter Hemmer, CEO of SynDermix AG. “We hope this temporary postponement may help in alleviating some of the pressure put on healthcare systems and safeguard the wellbeing of the patients and medical staff at the clinical sites.”
The SDX-3101 clinical trial is a randomised, double-blind study set to take place in 8 clinical investigational sites across Austria, Germany and Switzerland. The purpose of this study is to evaluate the safety and efficacy of SDX-3101, intended for use as the first drug-free and non-invasive treatment for CRSsNP, by reducing or suppressing symptoms, and improving patients’ quality of life.
Dr Carlos R. Camozzi, the project leader of the Company’s Bioelesonic™ technology platform stated: “We remain strongly committed to the development of the SDX-3101 project. We are continuously monitoring and consulting with the health authorities regarding the situation of the healthcare systems and the legal requirements in order to be able to communicate when the SDX-3101 clinical trial can be resumed.”
Further information on the clinical trial is available on ClinicalTrials.gov (Identifier: NCT04158596) and the World Health Organization (WHO) International Clinical Trials Registry Platform.
About SynDermix AG
SynDermix AG is a Swiss developer of innovative health technologies funded by private investors. The Company focuses on the development of effective and safe treatments that meaningfully respect patient convenience and address important unmet medical needs.
SynDermix has built a diversified portfolio of innovative assets which correspond to three distinct proprietary technology platforms: smart medical devices based on digital acoustic modulation; drugs and medical devices based on a topical nitric oxide-releasing formulation; and drug candidates based on a recombinant plant lectin. Its business model is to a large extent virtual, driven by a strategy of in-licensing, outsourcing and out-licensing; the Company enters into strategic partnerships with third parties for the acquisition, development and commercialisation of a robust portfolio of assets with high innovation value and commercial potential. For more information please visit: www.syndermix.ch
Dr Carlos R. Camozzi
Project Leader of Bioelesonic™ Technology Platform