Inventiva Pharma

Beleggen in aandelen beurzen Frankfurt DAX, Londen FTSE 100, Parijs CAC40
Terugnajaren
Forum gebruiker
Forum gebruiker
Berichten: 173
Lid geworden op: 19 jul 2019 13:50
waarderingen: 196
Contacteer:

Re: Inventiva Pharma

Bericht door Terugnajaren »

Inventiva announces completion of patient visits for its Phase IIb clinical study with lanifibranor in NASH

• Last patient last visit took place in the United States on March 16, 2020
• Publication of study head-line results expected for June 2020

Daix (France), March 17, 2020 – 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 last visit of the last patient out of the 247 patients enrolled in its Phase IIb clinical study with lanifibranor in NASH. The last patient biopsy was performed in February and the last safety visit took place in the United States on March 16, 2020. All biopsies have been analysed by the central hepatologist and the publication of the study head-line results is planned in June 2020, in line with Company’s expectations.
The NATIVE (NAsh Trial to Validate IVA337 Efficacy) trial is a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical study evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (NASH). The main purpose of the study is to assess the efficacy of lanifibranor in improving liver inflammation and ballooning, the two histological markers included in the definition of the regulatory endpoint of NASH resolution. Secondary endpoints of the study also include NASH resolution and improvement in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline.
Throughout the study, the safety profile of lanifibranor has been regularly assessed by an external, independent Data Safety Monitoring Board (DSMB). Four meetings of the DSMB took place between June 2018 and September 2019 and as no safety issues were reported, the DSMB repeatedly recommended the continuation of the study without any modification of the protocol, thus confirming the good safety profile of lanifibranor.
Prof. Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and co-principal investigator of the study, said: “With this last milestone before the publication of the study results achieved on schedule, I am very delighted to see that the trial is progressing as planned. The commitment and the quality of the work delivered by the clinicians and centers involved in the trial have been outstanding and I am sure this will result in high quality data. I am eager to see the results of this trial and to continue working on the development of lanifibranor.”
Prof. Manal Abdelmalek, M.D., M.P.H. from Duke University and co-principal investigator of the study with Prof. Sven Francque, added: “I am very pleased to have completed this last patient visit and I am proud of our team who has been able to accelerate patient enrollment in the United States. The profile of lanifibranor, as a drug candidate that could prove beneficial to NASH patients worldwide, is strong and compelling. I look forward to the successful completion of this study and the upcoming publication of the study head-line results.”
Pierre Broqua, CSO and cofounder of Inventiva, stated: “Backed by the solid design and roll-out of the NATIVE clinical study and the preclinical and clinical results generated by lanifibranor so far, we are convinced that its profile as a pan-PPAR agonist and its ability to combine the beneficial effects of all three PPAR isoforms constitute a clear advantage in the treatment of NASH. These characteristics give our leading drug candidate a differentiated mechanism of action that should enable it to meet the efficacy endpoints of our Phase IIb clinical study. We are looking forward to publishing the head-line results in the next few months, which, if positive, will support the launch of the pivotal Phase III study with lanifibranor.”
•••
About lanifibranor
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 main purpose of the study is to assess the efficacy of lanifibranor in improving liver inflammation and ballooning, the two histological markers included in the definition of the regulatory endpoint of NASH resolution. 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, and also in various other fibrosis measures, in several metabolic markers, as well as in steatosis, inflammation and ballooning as measured using the “NAS” score, and safety.
The trial 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 June 2020.

About Inventiva
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 significant 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. A Phase I/II clinical trial in children with MPS VI is currently under preparation following the positive results of the Phase IIa clinical trial in adult MPS VI patients published at the end of 2019.
In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic partnership with AbbVie in the area of autoimmune diseases. 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. This collaboration entitles Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial objectives, in addition to royalties on any approved products resulting from this partnership.
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 chemical 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

Contacts
Inventiva
Frédéric Cren
Chairman & CEO
info@inventivapharma.com
+33 3 80 44 75 00
Brunswick Group
Yannick Tetzlaff / Tristan Roquet Montegon /
Aude Lepreux
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

Grtz,
Terugnajaren



Gebruikersavatar
And its gone!
Forum actieveling
Forum actieveling
Berichten: 624
Lid geworden op: 30 mei 2018 21:25
waarderingen: 240
Contacteer:

Re: Inventiva Pharma

Bericht door And its gone! »

Pijnlijk om dikke winst te zien smelten als sneeuw voor de zon.
Heb nog geen enkel stuk verkocht.
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

beursfre
Forum gebruiker
Forum gebruiker
Berichten: 131
Lid geworden op: 02 mar 2018 15:26
waarderingen: 28
Contacteer:

Re: Inventiva Pharma

Bericht door beursfre »

And its gone! schreef:
18 mar 2020 12:58
Pijnlijk om dikke winst te zien smelten als sneeuw voor de zon.
Heb nog geen enkel stuk verkocht.
moet ook niet ;)
Asit (0,23) - Biocartis (4,10) - IBA (9,15) - Inventiva (2,75) - Mdx (0,90) - PostNl (1,40)- Pharming (1,17) - Orange (18,00) - Wereldhave (11,50) - Shell (15,10)

NewB76
Forum actieveling
Forum actieveling
Berichten: 705
Lid geworden op: 21 jul 2018 13:41
waarderingen: 153
Contacteer:

Re: Inventiva Pharma

Bericht door NewB76 »

Flink volume vandaag !
Marcos liked last!

Gebruikersavatar
And its gone!
Forum actieveling
Forum actieveling
Berichten: 624
Lid geworden op: 30 mei 2018 21:25
waarderingen: 240
Contacteer:

Re: Inventiva Pharma

Bericht door And its gone! »

Gisteren nog wat bijgelezen, Bij inventiva is mij het volgende opgevallen:

De NATIVE studie

Bij pb van 10/03 spreekt men van publicatie van resultaten H1 2020.
In het pb van 17/03 lezen we echter "Publication of study head-line results expected for June 2020"

Met de stille trom een kwartaal verschoven?
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

Gebruikersavatar
Naz-T
Forum actieveling
Forum actieveling
Berichten: 950
Lid geworden op: 06 sep 2018 20:48
waarderingen: 405
Contacteer:

Re: Inventiva Pharma

Bericht door Naz-T »

H1 is toch tem juni?
ritchie liked last!

Gebruikersavatar
And its gone!
Forum actieveling
Forum actieveling
Berichten: 624
Lid geworden op: 30 mei 2018 21:25
waarderingen: 240
Contacteer:

Re: Inventiva Pharma

Bericht door And its gone! »

Naz-T schreef:
27 mar 2020 07:35
H1 is toch tem juni?
Nog niet goed wakker vrees ik :lol:
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

Gebruikersavatar
And its gone!
Forum actieveling
Forum actieveling
Berichten: 624
Lid geworden op: 30 mei 2018 21:25
waarderingen: 240
Contacteer:

Re: Inventiva Pharma

Bericht door And its gone! »

BRIEF-Inventiva Provides Business Update In Context Of COVID-19 Pandemic
18:28 (07/04) - Bron: Reuters
April 7 (Reuters) - INVENTIVA SA IVAA.PA :
* INVENTIVA PROVIDES A CORPORATE BUSINESS UPDATE IN CONTEXT
OF
COVID-19 PANDEMIC
* PUBLICATION OF TOP-LINE RESULTS OF PHASE IIB NATIVE
CLINICAL
TRIAL FOR LANIFIBRANOR IN NASH ON TRACK FOR JUNE 2020

* STRONG CASH POSITION WITH CASH RUNWAY UNTIL END OF Q2
2021,
BEYOND NEXT ANTICIPATED KEY CLINICAL MILESTONES OF COMPANY

* ON CORONAVIRUS: AS OF TODAY, NO EMPLOYEES HAVE BEEN
INFECTED
WITH COVID-19 TO KNOWLEDGE OF COMPANY
* CASH POSITION AMOUNTED TO EUR 35.8 MILLION AS AT DECEMBER
31,
2019, COMBINED WITH EUR 15.0 MILLION CAPITAL INCREASE COMPLETED
IN FEBRUARY 2020
* INVENTIVA CANNOT EXCLUDE A DELAY IN SELECTION OF A
PRE-CLINICAL
CANDIDATE FOR ITS YAP-TEAD PROGRAM
* IT IS TOO EARLY FOR COMPANY TO BE ABLE TO PROPERLY ASSESS
IMPACT
OF COVID-19 PANDEMIC ON TIMING OF YAP-TEAD PROGRAM


Source text for Eikon:
Further company coverage:

(Gdansk Newsroom)
((gdansk.newsroom@thomsonreuters.com; +48 58 778 51 10;))
ritchie liked last!
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

Terugnajaren
Forum gebruiker
Forum gebruiker
Berichten: 173
Lid geworden op: 19 jul 2019 13:50
waarderingen: 196
Contacteer:

Re: Inventiva Pharma

Bericht door Terugnajaren »

PB (ingekort mbt blabla)

Inventiva to provide an update on the NATIVE Phase IIb clinical trial in NASH during a Key Opinion Leader webcast

• Event to take place on May 4, 2020 at 10:00 am (ET) / 4:00 pm (CET)
Daix (France), April 21, 2020 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (“NASH”), mucopolysaccharidoses (“MPS”) and other diseases with significant unmet medical need, today announced that it will host a webcast presentation with two Key Opinion Leaders on May 4, 2020 to provide an update on its Phase IIb NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor for the treatment of NASH ahead of the release of headline results, which is expected in June 2020.
With the participation of Prof. Sven Francque, M.D., Antwerp University Hospital, co-principal investigator of the NATIVE clinical trial, and Prof. Pierre Bedossa, M.D., Paris-Diderot University, the central pathologist in charge of the biopsy analyses of the NATIVE clinical trial, the Company will discuss the trial design and present the characteristics of the patient population. At this stage, the trial remains blinded, in line with the protocol.
During this event, which had initially been scheduled to take place during the International Liver Congress 2020 (European Association for the Study of the Liver), Inventiva will explain the methodology used for the analysis of patient biopsies in the NATIVE clinical trial, and compare the different screening approaches currently used in NASH clinical trials, in particular the Steatosis, Activity, Fibrosis (“SAF") and NAFLD Activity Score (“NAS") scoring systems.
Pierre Broqua, CSO and cofounder of Inventiva, said: "After the analysis of all biopsies in the NATIVE clinical trial announced in mid-March, this webcast represents the last event before the expected publication of the trial’s headline results in June 2020. Prior to the clinical data release, we would like to review the different aspects of the trial in detail and we are delighted to benefit, on this occasion, from the participation of Prof. Sven Francque and Prof. Pierre Bedossa, two highly recognized experts in the NASH field. In particular, we will focus on how the trial design and our innovative screening strategy based on the SAF score enabled us to meet our patient recruitment objectives, including a high percentage of patients with severe steatohepatitis associated with advanced fibrosis.”

The event details are as follows:
Date: Monday, May 4, 2020
Time: 10:00 am - 11:30 am (ET) / 4:00 pm - 5:30 pm (CET)
Speakers: Prof. Pierre Bedossa, M.D., Paris-Diderot University, pathologist in charge of the biopsy analyses of the NATIVE clinical trial

Pierre Broqua, CSO and cofounder of Inventiva

Prof. Sven Francque, M.D., Antwerp University Hospital, co-principal investigator of the NATIVE clinical trial

Connection details:
Option #1 – Webcast: https://edge.media-server.com/mmc/p/dmwekswt

Option #2 – Conference call:

Numbers:

France: +33 (0) 1 70 70 82 21
Belgium: +32 (0) 2 400 3439
Germany: +49 (0) 69 2443 7403
Netherlands: +31 (0) 20 715 7566
Switzerland: +41 (0) 44 580 6084
United Kingdom: +44 (0) 203 009 5709
United States: +1 646-787-1226

Access code: 5267504

The presentation document and the link to the webcast will also be available on Inventiva’s website in the “Investors – Investor Presentations” section. A replay of the event will be available at: http://inventivapharma.com/investors/in ... entations/.

Grtz,
Terugnajaren
And its gone! liked last!

Gebruikersavatar
And its gone!
Forum actieveling
Forum actieveling
Berichten: 624
Lid geworden op: 30 mei 2018 21:25
waarderingen: 240
Contacteer:

Re: Inventiva Pharma

Bericht door And its gone! »

Conference call heeft niet veel indruk gemaakt blijkbaar?
Iemand dit gevolgd of een transcript voorhanden?

Nog een maand tegen de results van fase IIb in NASH...
GOOGL, BAYN, DBK, CYAD, TNG, ALPHA, IPH, RDSA, IVA, VYGR, HARP, YMAB, BCYC, ZYME, GERN, BNTX, SWTX, BPMC, TRIL.

Deelnemen aan het forum + meer functies?

Discussieer met duizenden beleggers, minder
advertenties, ideaal voor smartphone, betere
gebruikservaring en gratis abonneren op favoriete
onderwerpen.


Plaats reactie