Preclinical and clinical development

Transferring the best of biodiversity from lab to patient’s bedside

DEINOVE's expertise focuses on preclinical studies and early phase proof-of-concept trials that concentrate most of the antimicrobial market value [1]: following a Phase II trial, a new anti-infective agents has a 73% chance of obtaining marketing authorization when the average is 58% for other drugs and 40% for an anti-cancer drug).

The preclinical and clinical development of new antimicrobials against severe and resistance infections is very challenging both in terms of design and conduct [2]. In addition to its internal expertise, DEINOVE relies on leading research organizations and a global network of expert clinicians. Today, the company is conducting several development programs including the Phase II clinical trial of its first antibiotic candidate in severe Clostridioides difficile infections.

Tackling the global crisis of antimicrobial resistance requires joint action between innovative biotech companies such as DEINOVE and global leaders in healthcare, academic institutions, governments & public health organizations. The recent years have shown an increase in the number of “push funding" policies aiming to incentivize biotech companies to develop new products in infectious diseases (R&D cost reduction), as well as the beginning of new “pull mechanisms" to create incentives for private sector engagement (viable market demand for antimicrobials). In this framework, the AGIR R&D program has been supported since 2017 by the Investments for the Future Program (€14.6m over 5 years for a total amount of €25m), materializing the commitment of the French government in the fight against antimicrobial resistance.

[1] Clinical Development Success Rate 2006-2015, BIO, Biomedtracker, Amplion, 2016
[2] Shlaes DM. Research and development of antibiotics: the next battleground. ACS Infect Dis. 2015 May;1:232–233

 

Expertise at work

Plateformes DEINOVE step5-6

Preclinical development

Design and perform, alone and in partnerships, in vitro and in vivo assays to establish the proof-of-principle of the antimicrobial candidate. Pilot regulatory pre-clinical studies conduct by Contract Research Organization.

 

Clinical development

Design and pilot the exploratory studies (Phase I and II) to establish the clinical proof of concept of the antimicrobial candidate in human (first demonstration of safety and efficacy).