GENFIT

Update on Regulatory and Clinical Activities Amid the COVID-19 Pandemic - Seite 2

Other trials are paused

Following guidance from regulatory authority recommendations and prioritizing the safety of our clinical trial participants, all phase 1 trials – which include pharmacokinetic, food effect and bioequivalence studies – have been put on hold. These studies are necessary to support the elafibranor NDA submission for NASH.

Enrollment of patients in the PK/PD trial in pediatric patients with NASH as well as the Phase 2 study addressing liver fat have also been paused.

While our NASH combination and PBC programs both continue with several work streams still being executed, we have decided to put on hold the initiation of the Phase 2 combination study, as well as that of the Phase 3 study in patients with PBC.

All supporting activities pertaining to continuation of ongoing studies or the initiation of new studies will continue in order to minimize potential delays when the pandemic crisis subsides.

NIS4 Diagnostic

Our diagnostic solution continues to be deployed in the clinical research field through our commercial partner Covance, a subsidiary of diagnostics leader LabCorp. While interest in NIS4 is high, there may be some limits in test utilization due to delays potentially experienced by some NIS4 clients as the result of the current COVID-19 situation.

GENFIT teams are progressing the in-vitro diagnostic (IVD) aspect of the program in parallel. 

Supply chain update

Although the COVID-19 pandemic is rapidly evolving, and our plans may change accordingly, at this stage we do not anticipate any supply disruption for any of our current or planned studies. We have on hand sufficient supply of elafibranor for all our clinical studies up to mid-2021, and we do not foresee any issues with supply of raw materials and production of commercial batches. Likewise, our partners and the GENFIT teams have put in place contingency plans to manage the operational aspects of our ongoing and planned trials, even under the current conditions.

Employee update

Our employees are fully committed and are doing their best to ensure business continuity during this crisis. The measures we have deployed are fully aligned with governmental measures recommended for impacted countries and will be adjusted as the situation evolves. These measures enable GENFIT to pursue the vast majority of our activities, while abiding by health authorities’ sanitary recommendations: remote work has been enacted for all compatible positions, social distancing measures are applied for employees still working in the office, safety protection procedures are enforced, and business travel is strictly limited to that which is considered absolutely critical for the Company’s operations.