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Largo
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Re: Abivax

Bericht door Largo »

From the current Abivax communication plan for ABX464:

$ABVX expects the topline results from the COVID-19 trial in Q4 20.

In Q4 the 2-years maintenance data in UC will also be published.

More than 100 patients already recruited for P 2b in UC. Trial is progressing well.
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koe_lio
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Re: Abivax

Bericht door koe_lio »

Largo schreef:
08 jun 2020 14:46
From the current Abivax communication plan for ABX464:

$ABVX expects the topline results from the COVID-19 trial in Q4 20.

In Q4 the 2-years maintenance data in UC will also be published.

More than 100 patients already recruited for P 2b in UC. Trial is progressing well.
nieuwe corporate slide deck bevat ook mooie efficacy vergelijking op slide 12, voor ulcerative colitis
https://www.abivax.com/wp-content/uploa ... ne2020.pdf

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timmy
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Re: Abivax

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https://www.webdisclosure.com/finance/s ... 34621.html

Had een week terug de helft verkocht op 21,6 en gisteren terug ingekocht op 20,65. Het mag al eens meezitten :)
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Re: Abivax

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ABIVAX: Abivax reports long-lasting two-year efficacy and safety data from ABX464 ulcerative colitis Phase 2a maintenance study

02.09.2020 / 21:00
The issuer is solely responsible for the content of this announcement.
Abivax reports long-lasting two-year efficacy and safety data from ABX464 ulcerative colitis Phase 2a maintenance study

Phase 2a open label maintenance results after second year of treatment confirm good safety profile and durable efficacy of 50mg once-daily oral ABX464
After the second year of continued treatment, 69% of patients were in clinical remission[1] and 94% benefited from a clinical response[2]
Readings of the endoscopies were performed centrally by independent reviewers; Median fecal calprotectin (31.6 µg/g) was in the normal range
Patient enrollment for ongoing Phase 2b ulcerative colitis trial is on track, with 69% (159/232) of patients randomized to date and recruitment expected to be completed by the end of 2020 and expected results in Q2/2021
Abivax is currently preparing all required steps to advance ABX464 into UC Phase 3
PARIS, France, September 2, 2020 - 9:00 p.m. (CET) - Abivax (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announces two-year Phase 2a maintenance data of ABX464 in ulcerative colitis (UC), showing that 69% of the patients were in clinical remission and 94% benefited from a clinical response. The patients suffering from moderate-to-severe UC were all intolerant and/or refractory to at least one existing treatment prior to entering the ABX464 study. These data confirm good safety and efficacy results of ABX464 during the second year of treatment, which were already observed during the induction and first year of the maintenance study.

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: "We are very excited about the two-year open label Phase 2a maintenance results, which provide further momentum for our clinical development efforts with ABX464 to address the high unmet medical need in UC. These recent findings reinforce the potential of ABX464 as a well-tolerated and efficacious once-daily oral therapy for patients with moderate-to-severe ulcerative colitis."

Out of 32 patients included in the active or placebo arm of the initial induction phase, 22 were enrolled in the 50mg once-daily open label ABX464 Phase 2a maintenance study. 19/22 patients stayed on treatment for 52 weeks and 16/19 patients completed the second year of ABX464 maintenance treatment. Readings for all endoscopies were performed centrally by independent reviewers. The data showed that 11/16 (69%) patients were in clinical remission and 15/16 (94%) benefited from a clinical response. 7/16 (44%) had endoscopic remission consisting of complete disappearance of colon/rectum lesions (endoscopic Mayo score=0). Median fecal calprotectin, the key biological marker of UC disease activity, which was normalized during the first year of treatment, remained at 31.6 µg/g (normal levels are below 50 µg/g).

ABX464 was safe and well tolerated and there were no serious adverse drug reactions reported. No patients were prematurely discontinued due to adverse event during this second year of ABX464 treatment.

Prof. Séverine Vermeire, M.D., Ph.D., Head of the IBD Center at the University Hospitals Leuven, Belgium, and principal investigator of the study, said: "The safety and durability of clinical efficacy after two years of continued treatment of UC patients, intolerant or refractory to existing treatments, are very promising. Especially as the central and independent endoscopy readings after two years confirm the good one-year maintenance results, where endoscopies were read locally. We are very motivated to continue enrolling patients in the ongoing ABX464 Phase 2b induction and maintenance study and hope to be able to confirm the findings from the Phase 2a study."

Prof. William Sandborn, M.D., Director of the Inflammatory Bowel Disease (IBD) Center at University of California (UC) San Diego Health, and Chief, Division of Gastroenterology at UC San Diego School of Medicine, added: "The two-year Phase 2a maintenance results confirm the potential of ABX464 to become a treatment option for UC patients who do not respond or stop responding to currently available treatments after a certain period of time, including biologics. This debilitating disease greatly affects patients' quality of life and requires expensive and cumbersome therapies. The innovative mechanism of action of ABX464 and data from this trial represent a promising new potential approach to the treatment of ulcerative colitis that could provide these patients with an easily administered, once-daily oral, long-term effective therapeutic option."


Update on Abivax's Phase 2b induction and maintenance studies in moderate-to-severe UC patients:

The study is currently ongoing in 15 European countries, Canada and the US, enrollment is on track with 69% (159/232) patients randomized to date in the induction study. Patient recruitment is expected to be completed by the end of this year with first top-level results to be communicated in Q2/2021. Out of 85 patients who completed the induction phase, only one patient did not roll over into the maintenance study, while the remaining 84 patients did. All patients in the maintenance study are receiving daily doses of 50mg oral ABX464, which shows a good safety profile consistent with previous studies. The clinical program in UC is Abivax's top priority and all necessary steps to further progress into Phase 3 studies are being prepared.


Update on other ongoing and planned clinical trials with ABX464:

Enrollment in the Phase 2a trials in rheumatoid arthritis is progressing well, with anticipated completion of recruitment by year-end. The Phase 2b/3 clinical trial in Covid-19 patients has been approved in all participating European countries and Brazil, where recruitment is ongoing and expected to be completed in Q4/2020, subject to the evolution of the pandemic. Following the recommendations of leading KOLs, Abivax is planning to go straight into a pivotal Phase 2b/3 trial for Crohn's disease, which is expected to start recruiting beginning of 2021.

******

About Abivax
Abivax, a clinical stage biotechnology company, is mobilizing the body's natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 - Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.
More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.
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timmy
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Re: Abivax

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https://www.finanznachrichten.de/nachri ... ck-124.htm

Bei Abivax richtet sich der Fokus unverändert auf ABX464. Nicht nur, weil der Wirkstoff ein Studienprogramm gegen Covid-19 durchläuft, sondern auch, weil die Leitsubstanz die Behandlung von chronisch-entzündlichen Erkrankungen erheblich verbessern könnte. Abivax sendet nach wochenlanger Nachrichtenflaute nun ein wichtiges Lebenszeichen.

Starke Ergebnisse
Die Franzosen haben am Mittwochabend 2-Jahres-Daten zur Langzeitwirkung und Sicherheit aus der Phase-2a-Erhaltungsstudie mit ABX464 zur Behandlung von Colitis ulcerosa publiziert. Demnach befanden sich 69 Prozent der Patienten, die kontinuierlich mit ABX464 behandelt wurden, in klinischer Remission, satte 94 Prozent zeigten sogar ein klinisches Ansprechen.

Wir freuen uns sehr über die ausgezeichneten 2-Jahres-Daten zur Wirksamkeit und Sicherheit aus der offenen Phase-2a-Erhaltungsstudie. Diese Ergebnisse verleihen uns das notwendige Momentum, unsere Anstrengungen zur klinischen Weiterentwicklung von ABX464 fortzusetzen und so eine Behandlungsmöglichkeit für den hohen medizinischen Bedarf in CU bereitzustellen", so Abivax-CEO Hartmut Ehrlich zu den jüngsten Daten. "Die jüngsten Resultate forcieren das Potenzial von ABX464 als gut verträgliche und wirksame, einmal täglich oral zu verabreichende Therapiemöglichkeit für Patienten mit mittelschwerer bis schwerer Colitis ulcerosa."

ABX464 wird in der Indikation Colitis ulcerosa derzeit in einer Phase-2b-Studie untersucht. Laut Abivax verläuft die Patientenrekrutierung wie geplant, 69 Prozent der Patienten wurden randomisiert. Die Ergebnisse der Studie stellen die Franzosen für das zweite Quartal 2021 in Aussicht.

Die jüngsten Daten bekräftigen Abivax in der Annahme, dass ABX464 gegen chronisch-entzündliche Erkrankungen wie Colitis ulcerosa nachhaltig wirken und eine neue Therapieoption für die Zukunft darstellen könnte. An der Börse finden die jüngsten Erhebungen regen Anklang, der AKTIONÄR-Hot-Stock kann zweistellig zulegen. Es bleibt dabei: Die Biotech-Aktie ist eine hochinteressante, aber auch enorm spekulative Depotbeimischung. Stopp: 14,00 Euro.

google translate:
Bij Abivax blijft de focus op ABX464. Niet alleen omdat het actieve ingrediënt een studieprogramma tegen Covid-19 doorloopt, maar ook omdat de hoofdstof de behandeling van chronische ontstekingsziekten significant zou kunnen verbeteren. Abivax stuurt nu een belangrijk teken van leven na weken van dood nieuws.

Sterke resultaten
De Fransen publiceerden woensdagavond 2-jarige langetermijnwerkzaamheids- en veiligheidsgegevens van het fase 2a-onderhoudsonderzoek met ABX464 voor de behandeling van colitis ulcerosa. Volgens dit was 69 procent van de patiënten die continu werden behandeld met ABX464 in klinische remissie, maar liefst 94 procent vertoonde zelfs een klinische respons.

"We zijn verheugd met de uitstekende 2-jarige werkzaamheid en veiligheidsgegevens van de fase 2a open-label onderhoudsstudie. Deze resultaten geven ons het momentum dat we nodig hebben om onze inspanningen voort te zetten om ABX464 klinisch verder te ontwikkelen als een behandelingsoptie voor de hoge medische sector. Om te voorzien in de vraag in CU, ”zei Hartmut Ehrlich, CEO van Abivax, over de laatste gegevens. "De laatste resultaten bevorderen het potentieel van ABX464 als een goed verdragen en effectieve eenmaal daagse orale therapie voor patiënten met matige tot ernstige colitis ulcerosa."

ABX464 wordt momenteel onderzocht in een fase 2b-studie bij de indicatie van colitis ulcerosa. Volgens Abivax verloopt de rekrutering van patiënten zoals gepland: 69 procent van de patiënten wordt gerandomiseerd. De Fransen voorspellen de resultaten van de studie voor het tweede kwartaal van 2021.

Largo
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Re: Abivax

Bericht door Largo »

Er kan natuurlijk nog vanalles mislopen, (cfr Filgotinib), maar de molecule is zeer veelbelovend.
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NewB76
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Re: Abivax

Bericht door NewB76 »

@Timmy
Vooral de commentaar van prof S. Vermeire ( cfr supra ) is belangrijk en richtinggevend .

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timmy
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Re: Abivax

Bericht door timmy »

(post genomen van een ander forum)
Van German Biotech via twitter:

The long term data on ABX464 ( $ABVX ) at UC looks very good. A comparison with Etrasimod ( $ARNA ) on ITT basis shows after 12 months:
Clinical remission -> 55% ABX464 vs 31% Etrasimod
Endoscopic improvement -> 73 % ABX464 vs 41 % Etrasimod

It should be noted that the ABX464 patients were significantly more pre-treated with biologics and that the majority of patients treated with etrasimod received a basic treatment with 5-aminosalicylates in parallel.

Consequently, ABX464 would have performed even better under comparable conditions.

I also looked at the long-term data on vedolizumab ( $TAK ).
In the VISIBLE 1 trial all UC patients who achieved clinical response in the induction phase were treated for one year.

Of the vedolizumab responders, 46% had clinical remission and 56% had mucosal healing after 1 year. These are clearly lower values than those achieved with ABX464 in the overall collective (responders and non-responders).

A major problem is that when UC is treated with biologics, their effect decreases significantly over time.

ABX464 also shows good results here: For the whole collective, 55% (ITT) clinical remission after 1 year (75% on a PP basis) and 50% (ITT) after 2 years (69% PP).

Clinical response after 2 years ABX464 (68% ITT, 94% PP) is better than after 1 year etrasimod (63%, 79%) despite usually decreasing effects during long-term treatment.

Overall, the results of ABX464 in UC are convincing. However, they must be confirmed in a larger trial.
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timmy
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Re: Abivax

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nieuwe corporate presentation (7 september 2020)
https://www.abivax.com/wp-content/uploa ... t.2020.pdf
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timmy
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Re: Abivax

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