CLINICAL TRIAL MILESTONE: last dosing group of Phase IIB clinical trial of therapeutic peptide solnatide started

The new therapeutic peptide solnatide aiming to reduce intensive care time for COVID-19 patients just achieved an important milestone. Solnatide successfully finished the first two dosing groups of the Phase IIB clinical trial, allowing the third and final part of the clinical trial to go ahead. With this highest dosing of solnatide yet the clinical trial continues in the study centres in Austria and Germany.

Solnatide treats lung damages in COVID-19 and other ARDS patients

Severely affected COVID-19 patients need intensive care and mechanical ventilation when they start to suffer from acute respiratory failure and pulmonary permeability oedema (PPO). About one third of these patients develop acute respiratory distress syndrome (ARDS) which results in a very high mortality rate if treated inadequately. Solnatide helps earlier clearance of liquids in the lungs. The peptide improves oxygenation and reduces the need for mechanical ventilation. This shortens the time in intensive care, currently one of the most limited resources in many health care systems.

Last dosing groups in Phase IIB clinical trial

Previous clinical studies have proven the safety and beneficial effects of solnatide in treating the respiratory condition ARDS. As part of the EU H2020 programme to develop COVID-19 treatments, the SOLNATIDE project receives financing to include COVID-19 patients in the Phase IIB clinical trials of ARDS patients. Following a risk-adjusted procedure, first a low and a middle dose were tested. Safety assessment of the first two dosing groups allowed now for continuation of the trial with the last and highest dosing of solnatide.

Like the previous dosing groups, this last stage of the trial follows the recently published clinical trial protocol: Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial.

Find out more about solnatide and the SOLNATIDE project

SOLNATIDE project website (https://www.solnatide.eu/)

SOLNATIDE scientific publications (https://www.solnatide.eu/news-media/publications/)

Clinical trial sponsor APEPTICO (http://apeptico.com/index-solnatide_in_horizon_2020)

SOLNATIDE project consortium partners

Five organisations from four countries make up the project consortium:

EU Funding Acknowledgement

This project has received funding from the EU special H2020 program “Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic (call ID: SC1-PHE-CORONAVIRUS-2020) under the Grant No. 101003595.

https://www.solnatide.eu/clinical-trial-milestone-last-dosing-group-started/

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