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Rheological Monitoring of Chronic Respiratory Diseases

Periodic Reporting for period 1 - RheoCare (Rheological Monitoring of Chronic Respiratory Diseases)

Reporting period: 2019-12-01 to 2020-05-31

Rheomuco aims to fight chronic lung diseases like COPD, the 3rd cause of death worldwide, as well as bronchiectasis and severe asthma. It also targets rare diseases like Cystic Fibrosis (CF) and Prima-ry Cilia Dyskinesia. Applications can be developed for infectious diseases: tuberculosis and even SRAS-viruses.
Rheomuco is a medical device which delivers a test within 10 minutes, with quantitative, reactive and reproducible biomarkers. With this decision support tool, healthcare professional (HCP) can:
• Predict exacerbations, anticipate crises to reduce hospitalizations and avoid emergency treat-ment,
• Evaluate and adapt treatments thanks to personalized monitoring when taking corticosteroids, antibiotics and mucolytics,
• Classify lung damage, in particular the risks of bronchial obstructions.
In Europe, we lead 2 Phase II clinical trials to valid medical benefits of the biophysical markers in COPD and CF. The precision medicine using companion tests of current drugs (ICS and azithromycin) aims to avoid costly hospitalisations and an irreversible loss of respiratory capacity for the patients.
The biophysical markers represent the physical properties of lung mucus: viscosity, elasticity and plasticity. Therefore they evaluate mucus propensity to clog and obstruct the pulmonary tract. For human, mucus samples come from sputum: a lung secretion from the lower part of the airways. This sample need to be homogenized with a standard procedure patented by Rheonova. The ob-jective of the Rheocare is to prepare the integration of the homogenizer to automate the sample preparation. This step is central because this manual procedure can be a source of errors by the addition of saliva in the mix. We develop a microfluidic channel to manage the homogenisation and integrate with the associated software this building block into the existing Rheomuco. We refine our commercialisation plan for medical use of the device by interviewing 16 key opinion leaders in Europe, China and the USA. We finally fine-tune our Intellectual Property strategy by focusing on the biomarkers protection.
"The objective is to prepare the integration of the homogeniser building block into the existing Rheomuco in view of its commercialisation. We identified three priority tasks to fit this work package: (i) develop an appropriate software interface, (ii) refine our commercialisation plan, and (iii) define our IP strategy.
Description of work performed:
Task #1 Interface & Software development
Objectives Design the piece of software dedicated to the integration of the RheoCare automated homogenisation system into Rheomuco:
• drive fluid motion in a controlled way (feedback loop)
• reproducibility and reliability testing
Task #2 Commercialisation plan
Objectives Execute go-to-market plan and business model in Europe:
• Interviews and demos for 10 KOLs in each country: Switzerland, Italy, Ger-many, Belgium and UK
• Events and fairs: ERS, ECFS, Medica
Task #3 IP strategy
Objectives Grant our freedom to operate and protect our automated homogenisation system
• analysis of the anteriority
• define the best IP options (patent, publications)
• define IP claims"
1. Technical perspectives
The homogenisation must now be validated with sputum samples, and compared to the current manual protocol. Then, the microfluidic homogenisation device must be implemented within Rhe-omuco as a consumable device. Fabrication process should be adapted to mass production, espe-cially by switching from 3D printing to moulding. The pumping system to inject the sample should also be integrated in Rheomuco’s body, and driven through the user interface.

2. Clinical perspectives
CF is a rare but well documented condition. While we develop a clinical program with partners in hospitals, we have access thank to them to a bunch of historical data over decades: exacerbation history, treatment history, genetic type, phenotype type, biological history (bacteria colonies, anti-bioresistances and airway capacity)… Those data can be easily correlated to rheological properties and we will be able to explore different approach to bring any medical benefits, as well as any eco-nomic benefits. The program will start in October 2020 for 2 years.
In contrary for COPD, the number of patient is very large (3rd cause of death in the world) but the is very few in term of pre-existing database as patients over a large period of time move from hospi-tal to hospital without track records. We choose one single approach: companion testing of azithromycin for class D patients under regular care in hospital. Azithromycin already offers a very good performance on the exacerbation frequency, but an on-going use (over 2 years) make its efficacy declines. Rheological testing aim to prescribe and to withdraw the treatment, to ensure a longer efficacy. The interventional clinical trial will start in July 2020 for 2 years.

3. Business development perspectives
3.1. Research applications
• Fundamental research: Physiopathology / Pharmacodynamics / Drug delivery
• Preclinical: In vitro efficacy / Drug benchmarking / Medical device benchmarking
• Clinical: In vivo efficacy/ Dose range finding / Secondary outcomes

3.2. Companion testing
Precision medicine with companion tests of current drugs aims avoid the costly hospitalisation and an irreversible loss of respiratory capacity for the patients. We look for partners like pharma companies to develop a new companion test. This approach can be used to stratify the patients most responsive to or to repurpose any drugs in other field.
Rheomuco device