Inventiva achieves a major milestone by completing patient recruitment for its Phase IIb clinical study with lanifibranor in NASH
- Last patient randomized in the Phase IIb NATIVE trial evaluating lanifibranor in NASH patients
- 247 patients randomized in the study, exceeding the initial target of 225 patients
- Publication of the study results expected in H1 2020
Daix (France), September 4, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the successful completion of patient recruitment for its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH).
A total of 247 patients have been randomized in the Phase IIb NATIVE trial, exceeding the initial target of 225 patients following an acceleration of inclusions over the last months. Patients were mainly recruited in sites located in Australia, Canada, Europe and the United States. The objective to recruit patients with a severe form of NASH was met as approximately 73% among them have a NAS score greater than or equal to six and 76% have a F2 or F3 fibrosis score. In addition, the study population includes more than 40% of patients with type 2 diabetes (T2DM), allowing Inventiva to conduct the planned subanalyses in this key patient group, where lanifibranor as an insulin sensitizer should be particularly beneficial. It is estimated that approximately half of the NASH patients globally have T2DM, and are at greater risk of poor clinical outcomes. To date, 146 patients have already successfully completed the six-month study confirming that the treatment is well tolerated.
Having reached this key recruitment milestone, the publication of the study’s headline results is expected for H1 2020.
The completion of patient recruitment follows three meetings of the NATIVE DSMB (Data Safety Monitoring Board), which had reviewed patient safety data and repeatedly recommended the continuation of the trial without changing the protocol, confirming the favorable safety profile of lanifibranor. These positive outcomes are consistent with the results of long-term toxicological studies and Phase I and Phase II clinical trials, as well as with the FDA’s decision in May 2019 to lift the peroxisome proliferator-activated receptor (PPAR) target class-related clinical hold for lanifibranor.
Prof. Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and Co-Principal Investigator of the study, said: “ Since the PPAR mechanism of action has already widely been validated for the treatment of NASH, and given lanifbranor’s unique profile as a pan‑PPAR agonist, this drug candidate should be able to reduce NASH and the fibrosis associated with it as well as to provide metabolic benefits. The analysis of patients with type two diabetes will also be of importance to confirm that lanifibranor is particularly suited to this population. ”
Prof. Manal Abdelmalek, M.D., M.P.H. from Duke University and Co-Principal Investigator of the study, stated: “ The completion of patient recruitment in this international study is excellent news. The study has been well conducted, and given the preclinical and clinical results generated by lanifibranor so far, we are confident that this treatment will prove to be a valuable approach to treat NASH patients.”
Marie-Paule Richard, M.D., Chief Medical Officer of Inventiva, added: “A great thank-you to all of the clinicians and patients participating in this international trial. The safety profile of lanifibranor and the way the study has been conducted so far are very encouraging. We are confident that this trial will reach its primary endpoint and we are looking forward to publishing the results in the first half of 2020, which, if positive, will support lanifibranor’s entry into the pivotal Phase III.”
Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (“PPAR”) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable safety and tolerability profile that has been observed in clinical trials and pre‑clinical studies to date.
Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of non-alcoholic steatohepatitis (“NASH”), a common and progressive chronic liver disease, for which there is currently no approved therapy.
About the NATIVE Phase IIb trial
The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (“NASH”). The goal of the trial is to assess the effect of lanifibranor on the improvement in liver inflammation and ballooning, which are two of the markers of the resolution of NASH. To be considered for inclusion, patients must have: a diagnosis of NASH confirmed by liver biopsy; a cumulative score of inflammation and ballooning (as measured using the steatosis, activity and fibrosis, or “SAF”, scoring system) of three or four out of four, indicating the presence of moderate to severe inflammation and ballooning; a steatosis score greater than or equal to one, indicating the presence of moderate to severe steatosis; and a fibrosis score less than four, indicating the absence of cirrhosis. The primary endpoint of the trial is a reduction in the combined inflammation and ballooning score of two points compared to baseline, without worsening fibrosis. Secondary endpoints include NASH resolution, improvements in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline as measured using the SAF score, improvements in various other fibrosis measures, improvements in several metabolic markers, improvements in steatosis, inflammation and ballooning as measured using the “NAS” score, and safety.
The trial has randomized 247 patients with NASH at more than 70 sites in Australia, Canada, Europe, Mauritius and the United States. Results of the trial are expected in the first half of 2020.
Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of diseases with significant unmet medical needs in the areas of fibrosis, lysosomal storage disorders and oncology.
Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates – lanifibranor and odiparcil – in non-alcoholic steatohepatitis (“NASH”) and mucopolysaccharidosis (“MPS”), respectively, as well as a deep pipeline of earlier stage programs.
Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies.
Inventiva is also developing odiparcil, a second clinical‑stage asset, for the treatment of patients with MPS, a group of rare genetic disorders. The Company is currently investigating odiparcil in a Phase IIa clinical trial for the treatment of patients with the MPS VI subtype.
In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. The Company has established two strategic partnerships with AbbVie and Boehringer Ingelheim in the areas of autoimmune diseases and idiopathic pulmonary fibrosis (“IPF”) respectively. AbbVie has started the clinical development phase of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. Both collaborations entitle Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the partnerships.
The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology a well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, around 60% of which are proprietary, as well as a wholly‑owned research and development facility.
Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (Euronext: IVA – ISIN: FR0013233012). www.inventivapharma.com
Chairman & CEO
+33 3 80 44 75 00
Yannick Tetzlaff / Tristan Roquet Montegon
+33 1 53 96 83 83
firstname.lastname@example.org +1 212 915 3820
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates.
Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release.
Readers are cautioned not to place undue reliance on any of these forward-looking statements.
Please refer to the “Document de référence" filed with the Autorité des Marchés Financiers on April 12, 2019 under n° R.19-006 for additional information in relation to such factors, risks and uncertainties.
Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Aino Health AB (publ): KALLELSE TILL EXTRA BOLAGSSTÄMMA I AINO HEALTH AB (PUBL)9.8.2020 19:15:00 CEST | Pressemelding
Aktieägarna i Aino Health (publ), org.nr 559063-5073 (”Bolaget”) kallas härmed till extra bolagsstämma onsdagen den 9 september 2020 i Stockholm. Med anledning av Coronapandemin (Covid-19) kommer den extra bolagsstämman att genomföras endast genom poströstning. Detta betyder att aktieägarna i Bolaget inte har rätt att närvara vid stämman, varken personligen eller genom ombud. Istället har aktieägarna rätt att utöva sin rösträtt per post genom att rösta i förväg enligt instruktionerna i denna kallelse. Rätt att delta vid stämman På grund av Coronapandemin och för att säkerställa aktieägares, anställdas och andra intressenters hälsa och säkerhet har styrelsen för Bolaget beslutat att aktieägarna inte ska ha rätt att närvara vid stämman, varken personligen eller genom ombud, och att den som inte är aktieägare inte ska ha rätt att närvara i enlighet med 20–26 §§ i lagen (2020:198) om tillfälliga undantag för att underlätta genomförandet av bolags- och föreningsstämmor. Aktieägarna har istä
Aino Health AB (publ): Aino Health decides on a fully secured rights issue of shares of approximately SEK 15.9 million9.8.2020 19:05:00 CEST | Press release
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN, SWITZERLAND, SINGAPORE, SOUTH AFRICA, OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, PUBLICATION OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL, BE SUBJECT TO LEGAL RESTRICTIONS OR WOULD REQUIRE REGISTRATION OR OTHER MEASURES. The Board of Directors of Aino Health AB (publ) (“Aino Health” or the “Company”) has, subject to approval at the Extraordinary General Meeting on 9 September 2020, decided to carry out a rights issue of a maximum of 10,623,319 shares (the “Rights issue”). The subscription price per share is SEK 1.50, whereby Aino Health upon full subscription in the Rights issue receives approximately SEK 15.9 million before issue costs. For every (1) existing share on the record date on 16 September 2020, two (2) subscription rights are received and three (3) subscription rights entitle the holder to subscribe for one (1)
Aino Health AB (publ): Aino Health beslutar om en fullt säkerställd företrädesemission av aktier om cirka 15,9 MSEK9.8.2020 19:05:00 CEST | Pressemelding
EJ FÖR OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION, DIREKT ELLER INDIREKT, INOM ELLER TILL USA, AUSTRALIEN, KANADA, NYA ZEELAND, HONGKONG, JAPAN, SCHWEIZ, SINGAPORE, SYDAFRIKA, ELLER I NÅGON ANNAN JURISDIKTION DÄR OFFENTLIGGÖRANDET, PUBLICERINGEN ELLER DISTRIBUTIONEN AV DETTA PRESSMEDDELANDE SKULLE VARA OLAGLIG, VARA FÖREMÅL FÖR LEGALA RESTRIKTIONER ELLER SKULLE KRÄVA REGISTRERING ELLER ANDRA ÅTGÄRDER. Styrelsen för Aino Health AB (publ) (”Aino Health” eller ”Bolaget”) har, förutsatt godkännande på extra bolagsstämman den 9 september 2020, beslutat att genomföra en företrädesemission av högst 10 623 319 aktier (”Företrädesemissionen”). Teckningskursen per aktie är 1,50 SEK, varigenom Aino Health vid full teckning i Företrädesemissionen erhåller cirka 15,9 MSEK före emissionskostnader. För varje (1) befintlig aktie på avstämningsdagen den 16 september 2020 erhålls två (2) teckningsrätter och tre (3) teckningsrätter berättigar till teckning av en (1) ny aktie. Teckningsperioden löpe
CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS7.8.2020 16:20:00 CEST | Press release
Sveriges Riksbank Bid procedure details Kommuninvest Bonds, 2020-08-11 Maturity dateLoanISIN codeCouponVolume, SEK million2021-09-152109 SE00069950641.00 %500+/- 2502023-02-222302 SE00096629430.75 %500+/- 2502024-10-022410 SE00104692051.00 % 500+/- 250 2026-02-042602 SE00137454520.75 % 500+/- 250 Maximum volume 2 BLN in total Settlement date 2020-08-13 Bids have to be entered by 11.00 on AUG 11, 2020 Highest permitted bid volume: 500 SEK million in issue 2109, 2302, 2410, and 2602. Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 11.15 (CEST) ON AUG 11, 2020 For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at http://www.riksbank.se
CONDITIONS FOR RIKSBANK BID PROCEDURES SEK GOVERNMENT BONDS7.8.2020 16:20:00 CEST | Press release
Sveriges Riksbank Bid procedure details Government Bonds, 2020-08-14 Maturity dateLoanISIN codeCouponVolume, SEK million2029-11-12 1061SE00112819220.75 %500 +/- 2502032-06-01 1056SE00045172902.25 %500 +/- 250 Settlement date 2020-08-18 Bids have to be entered by 10.00 on AUG 14, 2020 Highest permitted bid volume: 500 SEK million in issue SGB 1061 and 500 SEK million in issue SGB 1056 Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.10 (CEST)ON AUG 14, 2020. For more information, please contact: Trading desk at the Riksbank + 46 8 696 6970 General and special terms and conditions can be retrieved at http://www.riksbank.se
CONDITIONS FOR RIKSBANK BID PROCEDURES SEK COVERED BONDS7.8.2020 16:20:00 CEST | Press release
Sveriges Riksbank Bid procedure details Covered Bonds, 2020-08-13 Maturity dateLoanISIN codeCouponVolume, SEK million2023-09-20 5533 SE00104427311.25 %1,000 +/- 5002022-12-21 575 SE00105465721.50 %1,000 +/- 500 2023-06-011587SE00104413031.50 %1,000 +/- 5002023-03-15192SE00101332071.00 %1,000 +/- 5002022-12-212212SE00102970851.00 %400 +/- 2502023-09-20516SE00091903901.25 %400 +/- 2502023-06-21144SE00111674281.00 %400 +/- 250 Settlement date 2020-08-17 Bids have to be entered by 10.00 on AUG 13 2020 Highest permitted bid volume: 1,000 SEK million in issue 5533 1,000 SEK million in issue 575 1,000 SEK million in issue 1587 1,000 SEK million in issue 192 400 SEK million in issue 2212 400 SEK million in issue 516 400 SEK million in issue 144 Maximum volume 5 billion SEK in total Lowest permitted bid volume: 50 SEK million Bids only through counterparties approved by the Riksbank RESULT OF AUCTION WILL BE PUBLISHED NO LATER THAN 10.15 (CEST) ON AUG 13, 2020. For more information, please cont