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Home  /  Forum  /  Galapagos  /  GLPG1205 en GLPG1690

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Aandeel Galapagos AEX:GLPG.NL, BE0003818359

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GLPG1205 en GLPG1690

474 Posts
Pagina: «« 1 ... 4 5 6 7 8 ... 24 »» | Laatste | Omlaag ↓
  2. [verwijderd] 6 augustus 2019 22:03
    quote:

    FatCool schreef op 11 juli 2019 23:56:

    Op 8 juli een update van NOVESA: in juni er twee ziekenhuizen bij in Italië, één in de USA (nu vijf sites) en één in de UK (nu 2 sites). Met Leuven en drie ziekenhuizen in Spanje brengt dat het totale aantal studie centra op 13. En dat terwijl er slechts 30 patiënten geworven moeten worden.
    Op 2 augustus weer een nieuwe update geplaatst. Nog een ziekenhuis in België (Gent) erbij en een eerste ziekenhuis in Duitsland (Berlijn). Dus nu 15 plaatsen waar de 30 patiënten worden gezocht.

    Moet lukken zou je zeggen :).

    fc
  3. Pokerface 7 augustus 2019 17:25
    quote:

    FatCool schreef op 6 augustus 2019 22:03:

    [...]
    Op 2 augustus weer een nieuwe update geplaatst. Nog een ziekenhuis in België (Gent) erbij en een eerste ziekenhuis in Duitsland (Berlijn). Dus nu 15 plaatsen waar de 30 patiënten worden gezocht.

    Moet lukken zou je zeggen :).

    fc
    Mag ik dat zien als voorbereiding op een Fase 3 onderzoek van GLPG 1690 in Systemic Sclerosis? Hoe meer ziekenhuizen je nu al kunt betrekken bij een fase 2 onderzoek, hoe makkelijker het denk ik is om ze straks bij een fase 3 onderzoek te betrekken.
    Is het zo dat dit dezelfde ziekenhuizen zijn als voor ISABELA fase 3? Kan me voorstellen dat dat makkelijk zou zijn ivm dezelfde medicatie.
  4. [verwijderd] 7 augustus 2019 20:19
    Ziekenhuizen voor NOVESA zijn andere ziekenhuizen dan voor ISABELA. Logisch eigenlijk, omdat in de grotere steden bijna alle ziekenhuizen gespecialiseerd zijn in bepaalde ziektegebieden. En een huidziekte is een heel ander behandelgebied dan de longen.

    De eerste patiënt(en) in NOVESA is/zijn trouwens klaar met hun behandeling, want sinds eind juli is ook de "long-term extension" studie actief.

    clinicaltrials.gov/ct2/show/NCT039766...

    fc
  7. forum rang 4 Lama Daila 20 augustus 2019 21:14
    www.iex.nl/Forum/Upload/2019/11779622...
    Thoughts on GLPG1690. One potential concern voiced was that increased dosing of pirfenidone or nintedanib in the control arms could counter the decline in FVC leading to diminished clinical effect associated with GLPG1690. However, this is unlikely given the tolerability issues with pirfenidone and nintedanib and we expect higher than recommended dosing could lead to increased rates of patient drop off in the control cohorts. FRI analysis from the FLORA study remains a key basis for management confidence in the program, but FRI remains a no-go in the Phase 3 ISABELLA programs due to cost and agency reticence. Note, validation for GLPG1690 comes from Bristol-Myers (BMY; not rated) decision to pursue a new molecule targeting LPA1, downstream of GLPG1690's target, and Boehringer Ingelheim's (private) decision to in-license an autotaxin program despite passing on GLPG1690 two years ago. Per management, the enrollment in the ISABELLA programs are now accelerating and is currently ahead of schedule.
  9. forum rang 4 Lama Daila 31 augustus 2019 17:17
    quote:

    Wall Street Trader schreef op 31 augustus 2019 12:22:

    Expert Interview

    Slingshot members are talking to an expert!

    The topic is: Exploring the potential of FGEN's Pamrevlumab, GLPG1690 and BG00011 in Idiopathic Pulmonary Fibrosis

    slingshotinsights.com/projects/1095

    Zie vragen in bijlage
    Bijlage:
  10. Tessdevries 31 augustus 2019 18:48
    quote:

    FatCool schreef op 7 augustus 2019 20:19:

    Ziekenhuizen voor NOVESA zijn andere ziekenhuizen dan voor ISABELA. Logisch eigenlijk, omdat in de grotere steden bijna alle ziekenhuizen gespecialiseerd zijn in bepaalde ziektegebieden. En een huidziekte is een heel ander behandelgebied dan de longen.

    De eerste patiënt(en) in NOVESA is/zijn trouwens klaar met hun behandeling, want sinds eind juli is ook de "long-term extension" studie actief.

    clinicaltrials.gov/ct2/show/NCT039766...

    fc
    "Een huidziekte is een heel ander behandelgebied dan de longen". Helaas is dit volgens mij iets te kort door de bocht. Juist bij systemische sclerose kan zowel de huid als de longen worden aangetast door fibrose.

    reumanederland.nl/reuma/vormen-van-re...

  11. forum rang 6 pe26 10 september 2019 15:31
    Berenberg rapport over Galapagos 10 september 2019 (dank Avantiavanti).

    GLPG1690 the front runner among late stage, next generation IPF drugs.
    We believe the recent halting of Biogen’s BG00011 (STX-100) Phase IIb
    study places Galapagos in a race with FibroGen’s pamrevlumab, which
    recently began enrolling its Phase III study (ZEPHYRUS). Key opinion
    leader (KOL) diligence points to high enthusiasm for GLPG1690; the Phase
    III design is favorable; the dosing, a once daily pill, is preferred to both
    standard of care, which are dosed multiple times per day, and pamrev,
    which is dosed as an intravenous infusion.     We raise our peak sales
    estimate from $1.5bn to $2.0bn owing to favorable competitive dynamics.
    We also raise our probability of success assumption to 60% (from 50%)
    following Gilead’s review of blinded safety data in ISABELA, which was
    part of its diligence for the expanded collaboration.     Refer to pages 10-30
    for our deep-dive analysis, including KOL viewpoints.

    Kans op succes GLPG1690 binnen IPF wordt alsmaar hoger ingeschat.
    Berenberg schat de kans nu in op 60%.

    Op naar de IPF update van Galapagos.
    Eind deze maand rondom ERS-congres is ideale moment.

    ISABELA fase 3 studies liggen naar verwachting voor op schema.

  14. HansGarrincha 10 september 2019 19:55
    See:

    FierceBiotech
    @FierceBiotech
    ·
    Jul 18
    Under the deal, Boehringer and BridgeBio will develop BBT-877 for idiopathic pulmonary fibrosis (IPF), a rare and fatal disease in which progressive scarring in the lungs makes breathing difficult:
    www.fiercebiotech.com/biotech/looking...
  15. HansGarrincha 10 september 2019 20:04
    We also raise our probability of success assumption to 60% (from 50%)
    following Gilead’s review of blinded safety data in ISABELA, which was
    part of its diligence for the expanded collaboration.
    Deze passage uit het Beerenbergrapport had ik nog niet meegekregen. Dit had ik nergens gelezen (mijn schuld I presume...), maar opmerkelijke inside informatie!
  16. forum rang 5 Wall Street Trader 12 september 2019 12:53
    STIFEL (PT $188.00)

    We hope to see development acceleration in some late stage trials, for example, filgotinib in Crohn’s disease and ‘1690 in IPF. Other program updates: GLPG1690 ISABELA Phase 3 (in IPF) and NOVESA Phase 2 (in systemic sclerosis) trials continue enrolling patients. The PINTA trial in IPF with GLPG1205 is to
    finish recruitment by YE19. It is a 26w-long trial with patients in EU/Mid-East/North Africa (OUS). We estimate topline data from PINTA in 3Q20. For MOR106, together with collaboration partners MorphoSys and Novartis, the ongoing Phase 1 and 2 trials are underway. The Toledo program remains largely opaque. The phase 1 readout of GLPG3312, the first Toledo compound, is
    scheduled for 2H19 and followed with an initiation of PoC phase 2 study likely by YE19.

    Berenberg (PT € 200)

    GLPG1690

    We raised the value of GLPG1690 even as it is now partnered in the U.S. with
    Gilead primarily as we have upped the probability of success in the program to 70% (from 50%).     Given that GLPG1690 had not previously been evaluated in combination with SOC, we considered safety to be a key concern; how would combining these agents impact the side effect profile in a difficult to treat disease in an older patient population? With Gilead having access to blinded safety data, we think this aspect of the story is somewhat derisked, with the caveat that the data was likely based on a relatively small number of
    patients. If GLPG1690 is eventually approved for treatment of IPF, we estimate the value of GLPG1690 reach €50/share. As it is, we value GLPG1690 at €30/share (vs. prior €22/share).

    Barclays (UPSIDE CASE PT € 190.00)

    sHOULD THE manta SAFETY STUDY READ OUT POSITIVELY, IT
    WOULD LIKELY MEAN FILGOTINIB WOULD BE THE BEST-INCLASS
    JaK AND WE WOULD INCREASE OUR PEAK SHARE
    ASSUMPTIONS. sUCCESS IN THE PHASE 3 TRIALS FOR iPF
    ASSET GlPG 1690 WOULD ALSO RESULT IN US RAISING OUR NPV.

    GLPG 1690 / FIBROSIS

    WiTH 1690, GlPG HAS NOT SEEN ANY COMPOUND-SPECIFIC TOXICITY (WHEREAS bRISTOL mYERS HAS WITH THEIR COMPOUND). Gild HAS SEEN THE BLINDED DATA THUS FAR FOR THIS ASSET. tHE 1690 FUTILITY ANALYSIS WILL BE DONE AFTER 25% OF THE PATIENTS HAVE CONCLUDED ONE YEAR TREATMENT, so that is “more than a year away.” tHE Pinta STUDY OF GlPG 1205 IS EXPECTED TO BE FULLY RECRUITED BY YE19.

    H.C. Wainwright & Co (PT $205.00)

    Thoughts on GLPG1690.

    One potential concern voiced was that increased dosing of pirfenidone or nintedanib in the control arms could counter the decline in FVC leading to diminished clinical effect associated with GLPG1690. However, this is
    unlikely given the tolerability issues with pirfenidone and nintedanib and we expect higher than recommended dosing could lead to increased rates of patient drop off in the control cohorts. FRI analysis from the FLORA study remains a key basis for management confidence in the program, but FRI remains a no-go in the Phase 3 ISABELLA programs due to cost and agency reticence. Note, validation for GLPG1690 comes from Bristol-Myers (BMY; not rated) decision to pursue a new molecule targeting LPA1, downstream of GLPG1690's target, and Boehringer Ingelheim's (private) decision to in-license an autotaxin program despite passing on GLPG1690 two years ago. Per management, the enrollment in the ISABELLA programs are now accelerating and is currently ahead of schedule.

    Credit Suisse (PT € 174)

    Beyond filgotinib, we think GLPG1690 has blockbuster potential in IPF (we conservatively model >$1B peak sales at ~35% PoS, launching in ~2022).

    Our Blue Sky Scenario (PT € 225)

    Our blue sky valuation of €225 is based on 100% POS of filgotinib in rheumatoid arthritis, ulcerative colitis and Crohn's disease, as well
    as better-than-expected data from the pipeline drugs GLPG1690, and GLPG1972.
    Our blue sky valuation is based on a DCF driven by a 10% WACC and discounted cash flows through 2029, with 1% terminal growth rate thereafter.

    GLPG1690 in IPF has blockbuster potential: Galapagos has a small but rapidly advancing pipeline in idiopathic pulmonary fibrosis (IPF), a rare lung disease with high unmet need and large market potential. Current treatment options for IPF have limited efficacy and some significant side effects. Nonetheless, patient uptake of IPF therapy has been surprisingly strong with 2017 WW sales reaching $2B. Galapagos' lead IPF candidate GLPG1690 has a novel mechanism of action (MoA) with the positive Phase 2 (FLORA) trial setting the stage for the much larger 1,500 patient Phase 3 pivotal program
    (ISABELA 1 and ISABELA 2), with updates expected 2H20. Also in the pipeline for IPF is GLPG1205, currently in Phase 2 (PINTA). After the announced deal, Galapagos retains full EU rights, while Gilead will market the drug ex-EU. Phase 3 costs will be split 50/50, while Galapagos will receive a $325M milestone on US approval and 20-24% in tiered sales royalties.

    Nomura (PT $209)

    If ‘1690 is approved, GILD will pay GLPG $325mn;

    GLPG1690 (autotaxin) in IPF
    ISABELLA 1 (NCT03711162) and 2 (NCT03733444) Ph3 Trials for IPF
    • GLPG indicated on the 2Q19 call that recruitment is “good,” and they plan to provide a timeline update later in 2019.
    • The ISABELLA trial design was presented at ATS 2019.
    • Allow for accrual of a large, controlled dataset to warrant broad label and utilization.
    • Monotherapy P2a FLORA data supports potential efficacy in any setting, though
    combination with other IPF drugs may cause unexpected SAEs.
    – FLORA Ph2a data showed target engagement and favorable safety and tolerability.
    • There will be a futility analysis in 2020E, based on both safety and efficacy. GLPG1690 in Systemic Sclerosis
    • NOVESA (NCT03798366) Ph2 trial dosed first patient in 1Q19.
    • GLPG will provide recruitment timeline update in 2H19.

    Degroof Petercam (PT € 186)

    A promising mechanism of action in IPF

    GLPG1690 is an oral autotaxin inhibitor currently in Phase III clinical development. Autotaxin is an enzyme that converts lysophosphatidylcholine to the bioactive lipid lysophosphatidic acid (LPA).

    Autotaxin remains a promising target in IPF. The mechanism of action has been further validated through recent licensing deals and data by competitors. One of the largest players in IPF, Boehringer Ingelheim, recently announced a licensing deal with Bridge Biotherapeutics for up to USD 1.1bn (EUR 45m upfront) to get access to a Phase I autotaxin inhibitor, BBT-877. Further, Bristol-Myers Squibb obtained encouraging efficacy results with its LPA1 antagonist (BMS-986020) in IPF, demonstrating a significantly slower rate of decline in FVC vs. placebo. However, the program was discontinued due to compound-specific toxicity.

    GLPG1690 is currently in a pivotal trial, which should be completed in 2021 (data expected in 2022). Combination therapy will likely be the way forward in IPF. We appreciate the company’s decision to include treatment-naïve patients as well as patients on Ofev or Esbriet, which could allow to obtain a broad label, potentially including monotherapy as well as add-on (combination) therapy.

    Although the data on GLPG1690 are still limited and do not allow straightforward extrapolation to the Phase III trial, the demonstration of stable disease up to 12 weeks is encouraging for the evolution of GLPG1690 in IPF. We have assigned a probability of success of 45% to the program at this stage. Adding Gilead to the equation, our rNPV points to a valuation of EUR 1.1bn (EUR 20/share).

  20. forum rang 4 Lama Daila 14 september 2019 10:02
    In september (of na de zomer) ging Galapagos waarschijnlijk een update geven mbt de timeline van de recruitement en de mogelijke timing van de futility analysis, die gepland als 25% van de patiënten de 52W hebben doorlopen.
    Ik denk dat ze die 25% patienten (= 375 patienten, of gemiddeld 2 patienten per center ) reeds gerekruteerd hebben en dat die futility analysis dus in minder dan een jaar al kan uitgevoerd worden.
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