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Inventiva: highlights
Clinical stage biotech with focus onoral small molecules for high unmet needin fibrosis, lysosomal storage disorders and oncology
Two unencumbered late stage assetsin two high value indications-Lanifibranor- only pan-PPAR agonist in clinical development for NASH, Phase IIb data due in June-Odiparcil- first orally available therapy for MPS
A clinical stage partnership with AbbVie
-ABBV-157 RORprogramwith potential in several auto-immune indications currently in clinical development in patients with psoriasis
-Inventiva eligible to milestone payments and sales royalties
Compelling early stage pipeline-YAP-TEAD program in late pre-clinical stage approaching clinical candidate selection
State of the art R&D capabilitiesincluding wholly owned 'pharma scale' discovery facilities with adiscovery enginefocused on nuclear receptors, transcription factors and epigenetic targets-240,000 compound library, 60% of which are proprietary
Strong US and European shareholder base and experienced senior managementteam with a track record of operational and scientific excellence
Cash position allowing arunway until end of Q3 2021
Lanifibranor: theonly pan-PPAR agonist in clinical development for the treatment of NASH
Moderate and balanced pan-PPAR agonist activity(PPAR, PPARand PPAR) with differentiated chemical structure
Once daily oral administration
Efficacy demonstratedon insulin-sensitivity, dyslipidemia, steatosis, ballooning, inflammation, hepatic fibrosis and cirrhosis in preclinical models
Phase IIa(1)trial demonstrated pan-PPAR agonist activity,supporting dose selection for NASH clinical trial
Favorable safety profiledemonstrated in:
24-months rodent and 12-month monkey studies leading toPPAR class clinical hold liftedby FDA
Phase I trials with more than200healthy volunteers(2)and Phase IIa study with47TD2M patients
Approximately250patients have been treated for 24 or 48 weeks in our ongoing and completed Phase IIb clinical trials
In connection with these trials, lanifibranor has undergone a total of7 positive DSMB reviews
Composition of matter patent delivered in 59 countries and method of use patent granted in the US,
China and in the EU:limit of exclusivity 2035
FAST Trackdesignation granted by FDA
(1) Conducted by Abbott prior to our funding; (2) Including 125 healthy volunteers in the phase I conducted by Abbott prior to our funding
PPARefficacy is well established in NASH
PPARactivation by pioglitazone improves steatosis, ballooning, inflammation and metabolic markers in NASH patients after 6 months or 18 months of treatment
Pioglitazone (PPAR)
Belfort NASH study 6 month treatmentCusi NASH study 18 month treatment
Placebo | Pio | P | Placebo | Pio | P | |
Steatosis (% patients improved) | 38% | 65% | 0.001 | 26% | 71% | < 0.001 |
Inflammation (% patients improved) | 29% | 65% | 0.001 | 22% | 49% | = 0,004 |
Ballooning (% patients improved) | 24% | 54% | 0.001 | 24% | 51% | = 0,004 |
NASH resolution (% patients) | - | NA | - | 19% | 51% | < 0.001 |
Fibrosis (mean change in score) | - | NS | - | 0 | - 0.5 | = 0.039 |
Pioglitazone improves advanced fibrosis
Pioglitazone improves advanced fibrosis(stage F3-F4) as indicated by an increase in the number of NASH patients whose fibrosis stage changed from F3-F4 to F0-F2 at the end of treatment
Source: Corey KE and Malhi H, Hepatology 2016. Note: clinical trial not conducted by InventivaCorporate Presentation | 2020
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Inventiva SA published this content on 04 June 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 June 2020 07:26:07 UTC