Oxurion (voorheen Thrombogenics)

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sanderus
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Re: Oxurion (voorheen Thrombogenics)

Bericht door sanderus »

Bron: seeking alpha.

Novartis ends Wet AMD trial for Beovu citing safety concerns

May 28, 2021 5:22 PMNovartis AG (NVS)By: Dulan Lokuwithana, SA News Editor


Novartis (NYSE:NVS) announced the termination of its Phase 3 MERLIN study that was designed to evaluate Beovu (brolucizumab) 6 mg versus Regeneron's EYLEA (Aflibercept) 2 mg in patients with wet age-related macular degeneration (AMD).

Announcing year one results of the study where Beovu was given in four-week dosing intervals following the loading phase, the company said that the trial met its primary endpoint compared to aflibercept.

However, intraocular inflammation (IOI) including RV, and RO were more frequent in the Beovu arm compared to aflibercept 2 mg. (IOI: 9.3% vs 4.5% of which RV: 0.8% vs 0.0%; RO: 2.0% vs 0.0%.) while the overall rate of vision loss was 4.8% in Beovu arm vs 1.7% in the aflibercept arm.

“In the interest of patient safety, Novartis has decided to terminate the MERLIN study,” the company said adding that it has also ended RAPTOR and RAVEN studies which evaluated brolucizumab with six initial monthly injections in retinal vein occlusion.

Other relevant trial protocols will also be amended to discontinue the four-week dosing intervals after the loading phase.



Fase 3 studie met maandelijkse doseringen in natte AMD is gestopt.
Eerder was Beovu reeds goedgekeurd in natte - AMD maar niet voor maandelijkse doseringen. Kort na op de markt komen werden al safety problemen gemeld.
Beovu is momenteel ook onder review voor gebruik bij DME. Onderzoek bij RVO is ook gestopt voor 6 maandelijkse injecties.

Dit straatje lijkt dood te lopen. De verkoop en gebruik van Beovu gaat nog meer onder druk komen te staan.
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Hoebeet
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Re: Oxurion (voorheen Thrombogenics)

Bericht door Hoebeet »

En in plaats van nu te wachten totdat Ox de boel op hún manier, en eventueel met een ongewenste
partner doorheen de volgende fase heeft gekeuteld, béter maar meteen het uitgespaarde geld inzetten
om ook de resterende Ox-aandelen in te lijven.

Wachten is niet zinnig want het kost je niet alleen een veelvoud van de huidige koers; je verliest ook
minstens nét zo waardevolle time-to-market.

Morgen dus maar 'n bodje van 3,40. Dan hebben we dát ook alweer gehad. ;)
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Hoebeet
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Re: Oxurion (voorheen Thrombogenics)

Bericht door Hoebeet »

Maandag mag ook :D
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Biotechbeliever
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Re: Oxurion (voorheen Thrombogenics)

Bericht door Biotechbeliever »

Liefst een bod van 8 euro. :? Dan ben ik break even.

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Re: Oxurion (voorheen Thrombogenics)

Bericht door Ben.CC »

Nieuw artikel in Retina Specialist magazine



http://bt.e-ditionsbyfry.com/publicatio ... 09239&p=39
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Re: Oxurion (voorheen Thrombogenics)

Bericht door sanderus »

Arshad Khanani, MD,
MA, managing partner and director of clinical
research and fellowship at Sierra Eye
Associates in Reno, Nevada



Dit is 1 van de recruterende sites voor THR-149 in de fase 2 studie.

Where would THR-149 potentially fit in the retina
specialist’s toolbox? Subject to data, I could envision
THR-149 claiming its place as a monotherapy in patients with persistent central-involved DME despite
prior treatment with anti-VEGF therapy. THR-149 definitely holds potentialas a first-in-class, second-line
treatment for DME.Further down the road, I could
even envision the use of THR-149in combination with anti-VEGF for treatment-naïve patients
.


Oxurion heeft zo een anti-VEGF- PKAL molecule in preklinische ontwikkeling volgens De Haes. Daar is bijkomend onderzoek voor geweest bij Bicycle Therapeutics waar THR-149 vandaan komt.
Screenshot_20210602-165236_Samsung Notes.jpg
Zo een molecule zou een bijkomend voordeel kunnen geven voor alle DME patienten met verhoogde VEGF en PKAL levels. Dus alle zwart bruine staafjes hierboven
U kunt zich hier registreren waarna u de bijlage kunt bekijken.
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Re: Oxurion (voorheen Thrombogenics)

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Oxurion Nets a Fresh $36 Million, Names New CEO as Candidates Advance in Pipeline

June 2, 2021 Karen Blum

Oxurion NV, the Brussels-based biopharmaceutical company formerly known as ThromboGenics, entered into a capital commitment agreement of up to $36 million (€30 million) with Negma Group, a Paris-based financial institution, as the company’s two lead retina candidates progress through the development pipeline.

Negma Group has committed to subscribe to up to $36 million in equity in tranches over a 12-month period through mandatory convertible bonds at Oxurion’s discretion, the two companies said in a joint news release.

“I am happy that we have been able to agree on this flexible financing agreement, which is under our control and can be exercised at our discretion,” said Patrik De Haes, MD, the former CEO of Oxurion, in a prepared statement. “Access to these funds will allow us to focus on progressing our two exciting novel and differentiated back of the eye drug candidates.”
An Oxurion press spokesman declined a request for an interview.

Change in Leadership
Oxurion also announced on May 17 that Dr. De Haes was stepping down from day-to-day management of the company to become non-executive chairman. In his place, Tom Graney, CFA, has been promoted from chief financial officer to CEO. Graney joined Oxurion as CFO last October and has more than 25 years’ experience in senior finance, strategy, business development, and operational roles.

Pipeline
The company has two molecules under development for the treatment of diabetic macular edema (DME). THR-149 is a plasma kallikrein inhibitor being developed as a potential new option for DME patients who don’t respond well to anti-VEGF treatments. The agent is in Phase II trials, with results expected in mid-year for the first part of the trial and early 2023 for the second part, Dr. De Haes said last year at the OIS European Innovation Showcase.

The company also expects to initiate by mid-year a Phase II trial with THR-687, a pan-RGD (arginylglycylaspartic acid) integrin inhibitor being developed as a potential first-line therapy for DME patients, he said.

Trial Results
A Phase I, single-injection study of THR-149 evaluating three doses showed the drug to be well-tolerated and safe, with no dose-limiting toxicities, Dr. De Haes said at the showcase. The study also looked at efficacy, including changes to patients’ best-corrected visual acuity (BCVA).

Across all doses, a rapid onset of action in mean BCVA was observed from day 1, with an increase of close to 4 letters, and a 7.5-letter improvement by day 14. “Three months later, we still had 6 letters of improvement from one single injection in those patients,” he said.

The Phase II study, dubbed KALAHARI, is a two-part study recruiting 122 patients with central-involved DME who respond suboptimally to anti-VEGF monotherapy, according to a company press release. The first part will assess three dose levels of the drug to find the optimal one. The second part will compare one dose of THR-149 with aflibercept as a comparator.

A Phase I clinical study of THR-687 found that drug, too, was well-tolerated and safe, with no serious adverse events, the company reported in 2020. The single-injection study evaluating three doses found a close to 5-letter BCVA improvement on day 1 in the highest-dose tested (2.5 mg), Dr. De Haes said at the showcase. By day 14, that had improved to 12 letters. Three months out, there still was a 12.5-letter improvement, he said.

Preclinical activities suggest the drug also holds the potential to improve outcomes for patients with wet age-related macular degeneration and retinal vein occlusion, he said.


https://ois.net/oxurion-nets-a-fresh-36 ... -pipeline/
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Re: Oxurion (voorheen Thrombogenics)

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Karen dacht kennelijk: "Laat ik 't nieuws van de afgelopen 12 maanden even samenvatten" :D
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Xem
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Re: Oxurion (voorheen Thrombogenics)

Bericht door Xem »

Terug “mid-year”.
Bij THR 317 werden resultaten ook “mid year”, in werkelijkheid kwamen ze eind augustus ...

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Re: Oxurion (voorheen Thrombogenics)

Bericht door Smokey the bear »

Nieuwe ceo....misschien betere communicatie nu..
Time will tell









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