SOLNATIDE Project Research Plan - The work packages of SOLNATIDE

Work Packages

Work Package 1 – Clinical Trial Management

WP1 is dedicated to oversee the fulfilment of any ethical requirements for a project of this scope. As requested by the EU, the funding body of the SOLNATIDE project, these requirements include identification and recruitment of patients for the clinical studies, informed consent procedures, incidental findings, data protection and many more.

WP1 will produce three confidential deliverables to be submitted to the EU.

The work package leader is RTDS, additionally, partners APEPTICO and OPIS are mainly involved.

Work Package 2 – Clinical Trial Management

The main objective of WP2 is to set up and run the COVID-19 clinical studies for the SOLNATIDE project. This includes the regulatory set up, communication with all study sites and regulatory authorities, and clinical data management.

This WP will produce six confidential reports to be submitted as deliverables to the EU. Two of the five project milestones for the SOLNATIDE project involve WP2:

Milestone 1 Protocols & contracts signed for solnatide manufacturing & clinical trial
Milestone 2 Filing of pharmacovigilance for Compassionate Use

The work package leader is OPIS, additionally, partner APEPTICO is mainly involved.

One of the main outputs of the SOLNATIDE project is the immediate use of the solnatide compound for COVID-19 patients. With the support from the EU we can now offer solnatide for the treatment of mechanically ventilated patients with severe COVID-19 within the Compassionate Use Program and outside.

Entry in the Austrian BASG register for Compassionate Use of solnatide (“Overview Compassionate Use Programs in Austria (AT)”)

Entry in the Italian register for Compassionate Use of solnatide from April 2020 and second Italian AIFA entry (“Programma di Uso Compassionevole con Solnatide per il trattamento dell’edema da permeabilità polmonare in pazienti affetti da COVID-19 con insufficienza polmonare acuta”)

Work Package 3 – Treatment of Patients with ARDS

WP3 is dedicated to the clinical treatment of patients severely ill with COVID-19 submitted to the Intensive Care Unit (ICU). They show symptoms of Acute Respiratory Distress Syndrome (ARDS) and need mechanical ventilation. The clinical centre is responsible for recruiting suitable patients for the study on the solnatide compound and treating them according to the Clinical Study Protocol.

WP3 will produce 2 reports to be delivered to the EU, one of which is a public deliverable; moreover, Milestone 3 (Completion of dosing group B) is the responsibility of WP3.

The work package leader is LMU; additionally, APEPTICO is involved in WP3 as needed.

Work Package 4 – Solnatide API Manufacture & Characterisation

WP4 is focussing on the manufacturing and physiochemical characterisation of the solnatide Active Pharmaceutical Ingredient (API) compound. These procedures follow the Good Manufacturing Practice (GMP) and all requirements needed for ICH, Ph.Eur. and USP registrations. Moreover, impurities will be analysed and characterised and 3D models of the peptides’ structure visualised.

WP4 will produce three deliverables, one of which will is public and alraedy available: public deliverable (D4.1 on Good Manufacturing Practice). It is involved in reaching two project milestones:

Milestone 1 Protocols & contracts signed for solnatide manufacturing and clinical trials
Milestone 4 Production of solnatide API

The work package leader is BCN; additionally, partner APEPTICO is involved in fulfilling tasks of WP4.

Work Package 5 – Solnatide IMP Formulation & Manufacture

WP5 is focusing on the solnatide IMP formulation and manufacturing, which is supplied by partner BCN and outputs from WP4. Manufacturing will be in compliance with requirements for ICH, Ph.Eur. and USP registrations.

This WP will produce four deliverables. The final deliverlable D5.4 – a report on the suitability of solnatide IMP for the treatment of COVID-19 patients is a public deliveralbe. In addition, two project milestones are connected to WP5:

Milestone 1 Protocols & contracts signed for solnatide manufacturing & clinical trial
Milestone 5 Manufacture of solnatide IMP

The work package leader is APEPTICO.

Work Package 6 – Project Management & Communication

WP6 is responsible for the management of the project as a whole, including inviting to regular General Assembly participants to meetings, and assisting with the timely reporting and deliverable finalisation. In addition, WP6 also involves communication activities for external stakeholders via social media and other communication channels to present the project, project partners and disseminate its results and publications for maximum impact and atakeholder outreach.

This work package will produce five confidential reports as deliverables for internal use.

The project manager RTDS works closely together with the scientific coordinator APEPTICO, while all other project partners will assist with managerial and communication tasks as needed.

Work Package 1 - Ethical Requirements

Work Package 2 - Clinical Trial Management

Work Package 3 - Treatment of Patients with ARDS

Work Package 4 - Solnatide API Manufacture & Characterisation

Work Package 5 - Solnatide IMP Formulation & Manufacture

Work Package 6 - Project Management & Communication

solnatide@rtds-group.com