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Jason Gerberry -- Bank of America Merrill Lynch -- Analyst Thanks, Elizabeth. Hey, guys. Maybe just for me, just on your selective TYK2. Can you talk a little bit about how you see the molecule differently than in Bristol's TYK2? And any important pharmacologic attributes of the molecule you think help differentiate and when we might get some more early stage data on that molecule. And then just on the situation with France and the female-only label, is that unique to France? I guess if something were surprising to happen that was discordant with the 13-week results. Just wondering if a female-only label is something that you view as a plausible label for the drug if something, again, discordant with the 13-week results were to pop up. Walid Abi-Saab -- Chief Medical Officer and Member of Management Board Okay. This is Walid. I'll take the two questions. So our molecule as a domain kinase inhibitor versus the messages in arsenic modulator. How will that translate in the clinic? Really is the big question, and for us, that's really where the money is at the end of the day. Preclinically, our molecule is selective and they're highly selective actually. And based on that, that's why we advanced it in development. In the clinical data and healthy subjects, we've had very good data from PK compatible with once a day dosing. In addition, we've had some very good pharmacodynamic activity as well, which have confirmed what we have seen preclinically. And there's been no changes. As you know, we monitor these very carefully. We're quite similar with the JAK and mature in that space, changes in sort of lipid profile or changes in life of cells, so on and so forth. We have not seen anything with our compound again still within a Phase I healthy volunteer setting, but still, we can make healthy comparisons to our other molecules. We are eagerly awaiting our Phase 1b study, which is, again, a small study, about 30 patients, two doses versus placebo in a 1-1-1 ratio. four weeks. This will give us a sense of how the compound is performing. But honestly, if you ask me what is the best way to compare it to Deucravacitinib is to run a rightsized Phase IIb trial similar to what they've done in psoriasis, most likely psoriatic arthritis but I think psoriasis would the one -- the area that's more validated or we have much more data, and then we can truly compare like-for-like both drug arms. So as to sharing the data, we look forward to doing that at the earliest possibility and regarding mechanism of action, our target would be the upcoming hematology conference. I cannot promise 100% because I cannot promise that they will accept but that is our target. And the -- for the psoriasis data will be the first dermatology conference that will be coming up and we'd be talking at that.
So as to sharing the data, we look forward to doing that at the earliest possibility and regarding mechanism of action, our target would be the upcoming hematology conference. I cannot promise 100% because I cannot promise that they will accept but that is our target. EHA2021, 9-17 juni:ehaweb.org/congress/eha-congress-2021... ehaweb.org/assets/Uploads/Congresses/... And the -- for the psoriasis data will be the first dermatology conference that will be coming up and we'd be talking at thatwaset.org/dermatology-conferences-in-...
Lama Daila schreef op 27 mei 2021 15:15 :
Study met GLPG3667 (TYK2) is Completed
clinicaltrials.gov/ct2/history/NCT045... Data zou op een volgende dermatology conference gedeeld worden aldus Walid op conference call Q1. Gelet op completed datum begin mei en eerstvolgende conference 3-4 juni (https://waset.org/dermatology-and-dermatologic-surgery-conference-in-june-2021-in-rome) lijkt het me mogelijk dat we voordien een uitlezing van deze studie mogen verwachten? Edit: zoals Lama twee posts hierboven al aanhaalde via de onderste link.
GLPG3667 (TYK2) Mechanism: As a Tyrosine Kinase-2-targeting (TYK2) drug, GLPG3667 targets a receptor of the JAK family, implicated in IFN-a, IL-6, IL-10 and IL-12 signaling.Key TYK2 inhibitors in development
Galapagos meldt positieve resultaten met selectieve TYK2-remmer GLPG3667 in fase 1b-studie in psoriasis - Algemeen veilig en goed verdragen - Positief werkzaamheidssignaal bij psoriasispatiënten na vier weken - 40% van de patiënten met de hoge dosis GLPG3667 laat een verbetering zien van ten minste 50% in PASI-respons (PASI 50) na vier weken - Data ondersteunen de start van fase 2b dose range studie in psoriasis Mechelen, België; 14 juli 2021; 22.01 CET; gereglementeerde informatie - Galapagos NV (Euronext & Nasdaq: GLPG) rapporteert positieve topline resultaten met tyrosine kinase 2 (TYK2) remmer GLPG3667 in een fase 1b-studie bij psoriasispatiënten. GLPG3667 is ontwikkeld door Galapagos. Galapagos evalueerde GLPG3667, een zelf ontwikkelde TYK2 selectieve compound, in een gerandomiseerde, placebo-gecontroleerde, dubbelblinde fase 1b-studie bij 31 patiënten met een diagnose van matige tot ernstige psoriasis. Patiënten werden gerandomiseerd in een 1:1:1 verhouding en kregen een eenmaal daagse orale dosis GLPG3667 (lage dosis of hoge dosis) of placebo, gedurende een periode van vier weken. Voornaamste doelstellingen waren het evalueren van de veiligheid en verdraagbaarheid van GLPG3667, evenals tekenen van klinische activiteit na vier weken. GLPG3667 werd goed verdragen in deze fase 1b-studie. Eén patiënt in de groep met de lage dosis onderbrak de studie met één dag vanwege verergering van de psoriasis. Het merendeel van de treatment related adverse events (AEs) waren mild en van voorbijgaande aard. Er waren geen sterfgevallen of serious adverse events (SAEs) in de studie. Na vier weken hadden vier van de 10 patiënten in de hoge doseringsgroep een PASI1 50-respons, gedefinieerd als ten minste 50% verbetering in PASI ten opzichte van de beginwaarde, vergeleken met één van de 10 placebopatiënten. Er waren geen patiënten met een PASI 50-respons op de lage dosis GLPG3667. De vier responders in de hoge dosis groep van GLPG3667 bereikten een verbetering van 52%, 65%, 74% en 81% in hun PASI-scores ten opzichte van het begin, terwijl de patiënt op placebo een verbetering van 52% bereikte. Positieve werkzaamheidssignalen werden ook waargenomen met de hoge dosis voor andere eindpunten, waaronder het aangetaste lichaamsoppervlak en algemene beoordeling door arts en patiënt, vergeleken met placebo na vier weken. “We zijn verheugd over de positieve resultaten en het bemoedigende veiligheidsprofiel met GLPG3667 bij patiënten met psoriasis gedurende een periode van 4 weken,” zei Dr. Walid Abi-Saab, Chief Medical Officer van Galapagos. “Op basis van deze resultaten zijn we van plan om volgend jaar een wereldwijd fase 2b-programma in psoriasis te starten, als onderdeel van een programma gericht op de brede ontwikkeling van onze selectieve orale TYK2-remmer GLPG3667 in ontstekingsziekten.” “De PASI 50-scores en andere gegevens over de werkzaamheid na slechts 4 weken behandeling, in combinatie met het waargenomen veiligheidsprofiel, bieden goede ondersteuning om met deze compound een groter onderzoek in psoriasis te starten. Patiënten hebben behoefte aan alternatieve, vooral orale, behandelingen,” aldus Prof. Dr. Diamant Thaci, Professor in de Geneeskunde aan het Comprehensive Center for Inflammation Medicine, Universiteit van Lübeck, Duitsland. Galapagos is van plan om deze studieresultaten met GLPG3667 in te dienen voor publicatie op wetenschappelijke conferenties en in wetenschappelijke medische tijdschriften. GLPG3667 is een geneesmiddel in onderzoek en is niet goedgekeurd door enige regelgevende instantie. De werkzaamheid en veiligheid ervan zijn niet vastgesteld.
A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects Recruitment Status : Not yet recruiting First Posted : July 26, 2021 Last Update Posted : July 26, 2021clinicaltrials.gov/ct2/show/NCT04976270
Recruitment Status : Recruiting First Posted : July 26, 2021 Last Update Posted : October 15, 2021clinicaltrials.gov/ct2/show/NCT04976270
GLPG3667 Presentation at ACR21 Nov 8th, 2021 Dear investor, Yesterday (Monday Nov 8th), the Galapagos team gave an oral presentation on our TYK2 program with GLPG3667 at the American Congress of Rheumatology (ACR21). Please find below a short summary of the presentation (PDF available upon request). Pharmacological characterization of GLPG3667, a selective TYK2 inhibitor for treatment of inflammatory diseases. Presented by René Galien. Session: Cytokines & cell trafficking, November 8th 2021, 2:45-3:00PM ET The presentation gives information on the potency and selectivity of our GLPG3667 TYK2 compound and proof of pharmacological activity in a psoriasis mouse model (IL-23 driven), further supported by human healthy volunteer data. The data demonstrate that in human fresh blood cells, GLPG3667 displays selectivity for TYK2-dependent pathways toward JAK1- and JAK2-dependent pathways. This was confirmed in healthy volunteers dosed orally with GLPG3667 during a Phase 1 study. In the dermal ear inflammation psoriasis model, activity was shown with minimal effective once-daily oral dosing of 3 mg/kg. Further evidence came from healthy volunteer blood sample data post in vivo IFNa challenge, showing that GLPG3667 completely inhibited IFN-response gene signature. In conclusion, these data point to GLPG3667 as a selective TYK2 inhibitor with demonstrated activity in vivo, supporting its clinical development in inflammatory indications.acrabstracts.org/abstract/pharmacolog... Kind regards, The Galapagos IR teamir@glpg.com
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis (GALARISSO) Recruitment Status : Not yet recruiting First Posted : January 25, 2023 Last Update Posted : January 25, 2023clinicaltrials.gov/ct2/show/NCT05695950
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