Project

SOLNATIDE | Exploring safety, tolerability and clinical efficacy of solnatide IMP in COVID-19 patients

Goal: Exploration of safety, tolerability and clinical efficacy of solnatide investigative medicinal product (solnatide IMP) in patients infected with the 2019 new Cornoavirus.

SOLNATIDE will clinically test peptide-based products targeting life-threatening pulmonary diseases (such as oedematous respiratory failure, acute lung injury). APEPTICO’s lead-compound solnatide IMP has been designed for the therapeutic treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and various forms of PPO.

Date: 1 April 2020 - 31 December 2021

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Project log

Sandra Frank
added a research item
Background: In May 2018 the first patient was enrolled in the phase-IIb clinical trial “Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Edema in Patients with Moderate to Severe ARDS” With the onset of the COVID-19 pandemic in early 2020, the continuation and successful execution of this clinical study was in danger. Therefore, before the Data Safety Monitoring Board (DSMB) allowed proceeding with the study and enrollment of further COVID-19 ARDS patients into it, additional assessment on possible study bias was considered mandatory. Methods: We conducted an ad hoc interim analysis of 16 patients (5 COVID-19- ARDS patients and 11 with ARDS from different causes) from the phase-IIB clinical trial. We assessed possible differences in clinical characteristics of the ARDS patients and the impact of the pandemic on study execution. Results: COVID-19 patients seemed to be less sick at baseline, which also showed in higher survival rates over the 28-day observation period. Trial specific outcomes regarding pulmonary edema and ventilation parameters did not differ between the groups, nor did more general indicators of (pulmonary) sepsis like oxygenation ratio and required noradrenaline doses. Conclusion: The DSMB and the investigators did not find any evidence that patients suffering from ARDS due to SARS-CoV-2 may be at higher (or generally altered) risk when included in the trial, nor were there indications that those patients might influence the integrity of the study data altogether. For this reason, a continuation of the phase IIB clinical study activities can be justified. Researchers continuing clinical trials during the pandemic should always be aware that the exceptional circumstances may alter study results and therefore adaptations of the study design might be necessary.
Daniela Fichtenbauer
added an update
Safety assessment of the first two dosing groups allow for continuation of the trial with the last and highest dosing of solnatide. Have a look at the news:
 
Sandra Frank
added a research item
Background Acute respiratory distress syndrome (ARDS) is a complex clinical diagnosis with various possible etiologies. One common feature, however, is pulmonary permeability edema, which leads to an increased alveolar diffusion pathway and, subsequently, impaired oxygenation and decarboxylation. A novel inhaled peptide agent (AP301, solnatide) was shown to markedly reduce pulmonary edema in animal models of ARDS and to be safe to administer to healthy humans in a Phase I clinical trial. Here, we present the protocol for a Phase IIB clinical trial investigating the safety and possible future efficacy endpoints in ARDS patients. Methods This is a randomized, placebo-controlled, double-blind intervention study. Patients with moderate to severe ARDS in need of mechanical ventilation will be randomized to parallel groups receiving escalating doses of solnatide or placebo, respectively. Before advancing to a higher dose, a data safety monitoring board will investigate the data from previous patients for any indication of patient safety violations. The intervention (application of the investigational drug) takes places twice daily over the course of 7 days, ensued by a follow-up period of another 21 days. Discussion The patients to be included in this trial will be severely sick and in need of mechanical ventilation. The amount of data to be collected upon screening and during the course of the intervention phase is substantial and the potential timeframe for inclusion of any given patient is short. However, when prepared properly, adherence to this protocol will make for the acquisition of reliable data. Particular diligence needs to be exercised with respect to informed consent, because eligible patients will most likely be comatose and/or deeply sedated at the time of inclusion. Trial registration This trial was prospectively registered with the EU Clinical trials register (clinicaltrialsregister.eu). EudraCT Number: 2017-003855-47 .
Sandra Frank
added an update
Daniela Fichtenbauer
added an update
How does solnatide fight COVID-19? What is solnatide? Read more about our H2020 research project that tests the safety, tolerability and clinical efficacy of the solnatide peptide to treat COVID-19 patients.
 
Daniela Fichtenbauer
added an update
Have a look at our website for more details and follow us for updates and first results!
 
Stephen Webb
added a project goal
Exploration of safety, tolerability and clinical efficacy of solnatide investigative medicinal product (solnatide IMP) in patients infected with the 2019 new Cornoavirus.
SOLNATIDE will clinically test peptide-based products targeting life-threatening pulmonary diseases (such as oedematous respiratory failure, acute lung injury). APEPTICO’s lead-compound solnatide IMP has been designed for the therapeutic treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and various forms of PPO.