Aclaris Therapeutics (ACRS) - Marktkap: $43 M - Reboundplay (Seite 47)
eröffnet am 13.09.19 08:31:34 von
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ISIN: US00461U1051 · WKN: A1412H · Symbol: 8AT
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Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,5700 | +55,23 | |
| 5,4500 | +41,56 | |
| 141,00 | +41,00 | |
| 1,1500 | +34,98 | |
| 1,0000 | +33,33 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 12,150 | -12,72 | |
| 35,69 | -13,71 | |
| 29,40 | -16,95 | |
| 5,2500 | -19,23 | |
| 0,7300 | -19,34 |
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Die meisten schlafen wohl noch. 😄
Ich bin jetzt mit knapp 40% im plus. Wie steht dieses Forum zu Stopp loss Order in so nem Fall? Erstmal geht’s ja wahrscheinlich hoch, aber ich möchte am Ende nicht mit leeren Händen dastehen. Bei solchen Titeln sind ja extreme ausschläge in beide Richtungen immer wieder die Regel. Falls jemand nen schlauen Spruch hat mir her damit. 😄
Ich bin jetzt mit knapp 40% im plus. Wie steht dieses Forum zu Stopp loss Order in so nem Fall? Erstmal geht’s ja wahrscheinlich hoch, aber ich möchte am Ende nicht mit leeren Händen dastehen. Bei solchen Titeln sind ja extreme ausschläge in beide Richtungen immer wieder die Regel. Falls jemand nen schlauen Spruch hat mir her damit. 😄
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fuer diese phase I ergebnisse imho "uebertrieben"
...Phase-1-Studie am Menschen zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik
und Pharmakodynamik von oral verabreichtem ATI-450 bei gesunden Probanden ( n = 77).
Der Prozess bestand aus drei Teilen:
Single Ascending Dose (SAD) plus Lebensmitteleffekt (n = 32, 8 Probanden pro Dosiskohorte - 2 Placebos, 6 aktive).
Eine Einzeldosis von 10 mg, 30 mg, 50 mg und 100 mg wurde getestet.
Multiple Ascending Dose (MAD) (n = 30, 10 Probanden pro Dosiskohorte - 2 Placebos, 8 aktive).
10 mg BID-, 30 mg BID- und 50 mg BID-Dosen wurden über einen Zeitraum von 7 Tagen nach Verabreichung getestet.
Methotrexat-DDI (n = 15). Einzeldosen von 7,5 mg Methotrexat zum Einnehmen allein oder nach ATI-450 50 mg BID.
"Wir glauben, dass diese Daten das Fortschreiten von ATI-450 in die Phase 2 der klinischen Entwicklung unterstützen",
sagte Dr. David Gordon, Chief Medical Officer von Aclaris. "Das Potenzial eines oralen kleinen Moleküls, das mehrere entzündungsfördernde Zytokine unterdrückt, könnte für die Behandlung einer Reihe von
entzündungshemmenden Erkrankungen von großer Bedeutung sein."
Aclaris beabsichtigt, die erste klinische Phase-2-Studie bei Patienten mit rheumatoider Arthritis
im ersten Halbjahr 2020 zu starten.
quelle https://de.advfn.com/p.php?pid=nmona&article=81500603
Moin, ja da geht man mal früh schlafen und dann sowas! Glückwunsch allen, vielleicht kann man ja noch schnell rein huschen....
Was meint ihr....wird es so wie das letzte mal wo wir kurz nach Meldung die 40-50% gemacht haben und dann am gleichen Tage schon wieder 30% gefallen sind? Gruß
Was meint ihr....wird es so wie das letzte mal wo wir kurz nach Meldung die 40-50% gemacht haben und dann am gleichen Tage schon wieder 30% gefallen sind? Gruß
Guten Morgen,
kann es sein, dass nur wegen einer Phase 1 der Kurs so durch die Decke geht? Ich bin bei 1,50€ eingestiegen vor 2-3 Monaten, aber da ging es doch um andere News zu nem Produkt das bereits in Phase3 steckt und man dort auf positive Ergebnisse wartet um zumindest den Gap bei etwas über 4$ zu schließen. Phase1 ist jetzt noch nicht der große Bringer. Bin etwas verwirrt. Ist hier so ein Druck im Kessel? 😮
kann es sein, dass nur wegen einer Phase 1 der Kurs so durch die Decke geht? Ich bin bei 1,50€ eingestiegen vor 2-3 Monaten, aber da ging es doch um andere News zu nem Produkt das bereits in Phase3 steckt und man dort auf positive Ergebnisse wartet um zumindest den Gap bei etwas über 4$ zu schließen. Phase1 ist jetzt noch nicht der große Bringer. Bin etwas verwirrt. Ist hier so ein Druck im Kessel? 😮
Trading Spotlight
Antwort auf Beitrag Nr.: 62.332.040 von goldlutscher am 09.01.20 22:49:14AH schon das Volumen des ganzen Tages. Denke hier wird noch versucht günstig etwas zu covern. Morgen sollte jedoch endlich die Mauer brechen und es in Richtung Gap close laufen in nächster Zeit.
Gruß aaahhh
Gruß aaahhh
Zurück auf $2???
Antwort auf Beitrag Nr.: 62.331.980 von aaahhh am 09.01.20 22:38:46Ja das hoffe ich auch. Haben schließlich noch ein Gap zu schließen
Antwort auf Beitrag Nr.: 62.331.980 von aaahhh am 09.01.20 22:38:46WAYNE, Pa., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, today announced positive results from ATI-450-PKPD-101, a Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Phase 1 clinical trial of the investigational compound ATI-450. Preliminary data demonstrated that ATI-450:
resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
was generally well-tolerated at all doses tested in the trial;
had dose proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours; and
had no meaningful food effect or drug-drug interaction (DDI) with methotrexate.
ATI-450-PKPD-101 was a first-in-human, randomized, observer-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in healthy subjects (n=77). The trial consisted of three parts:
Single Ascending Dose (SAD) plus food effect (n=32, 8 subjects per dose cohort - 2 placebo, 6 active). A single dose of 10mg, 30mg, 50mg and 100mg was tested.
Multiple Ascending Dose (MAD) (n=30, 10 subjects per dose cohort - 2 placebo, 8 active). 10mg BID, 30mg BID and 50mg BID doses were tested over 7 days of administration.
Methotrexate DDI (n=15). Single 7.5-mg oral doses of methotrexate given alone or after ATI-450 50mg BID.
No serious adverse events or severe adverse events were reported, and no adverse events led to discontinuation of the study medication. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, nausea, and abdominal pain. All adverse events were mild. A trend of a decrease in absolute neutrophil count (ANC) was observed without correlated clinical sequelae. This effect is consistent with the pharmacodynamic profile of certain anti-TNF therapies1. Other laboratory findings were generally unremarkable.
In this trial, ATI-450 had dose proportional pharmacokinetics with a terminal half-life of 9-12 hours in the MAD cohort on day 7. The PK profile was not meaningfully affected when taking ATI-450 with a high fat meal. Further, co-administration of ATI-450 with methotrexate had little impact on methotrexate pharmacokinetics.
The pharmacodynamics of ATI-450 were evaluated by investigating the potential to inhibit production of key cytokines in ex vivo stimulated blood samples collected from subjects. At the 50mg BID dose (the dose with the highest degree of inhibition) at day 7 (12 hours post last dose): the mean trough drug levels were above the IC80 for TNFα, IL1β and IL8; IL6 plasma levels were inhibited by more than 50% for part of the dosing interval; and the mean trough drug level was above the IC80 for phosphorylation of Heat Shock Protein 27, a downstream substrate of MK2 (and marker of inhibition of the MK2 target).
“We believe these data support the progression of ATI-450 into Phase 2 clinical development,” said Dr. David Gordon, Chief Medical Officer of Aclaris. “The potential for an oral small molecule which suppresses multiple proinflammatory cytokines could be very meaningful for the treatment of a number of immuno-inflammatory diseases.”
Aclaris intends to initiate the first Phase 2 clinical trial in subjects with rheumatoid arthritis in the first half of 2020.
About ATI-450
ATI-450 is an investigational oral small molecule inhibitor of the p38α mitogen-activated protein kinase-activated protein kinase 2 (MK2) inflammatory signaling pathway. This pathway drives the expression of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this pathway include tumor necrosis factor α (TNFα), interleukin-1α and -1β (IL1α and IL1β), and interleukin-6 (IL6). On the basis of this mechanism, Aclaris is developing ATI-450 as a potential treatment for immuno-inflammatory diseases.
resulted in marked inhibition of TNFα, IL1β, IL8, and IL6;
was generally well-tolerated at all doses tested in the trial;
had dose proportional pharmacokinetics (PK) with a terminal half-life of 9-12 hours; and
had no meaningful food effect or drug-drug interaction (DDI) with methotrexate.
ATI-450-PKPD-101 was a first-in-human, randomized, observer-blind, placebo-controlled Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered ATI-450 in healthy subjects (n=77). The trial consisted of three parts:
Single Ascending Dose (SAD) plus food effect (n=32, 8 subjects per dose cohort - 2 placebo, 6 active). A single dose of 10mg, 30mg, 50mg and 100mg was tested.
Multiple Ascending Dose (MAD) (n=30, 10 subjects per dose cohort - 2 placebo, 8 active). 10mg BID, 30mg BID and 50mg BID doses were tested over 7 days of administration.
Methotrexate DDI (n=15). Single 7.5-mg oral doses of methotrexate given alone or after ATI-450 50mg BID.
No serious adverse events or severe adverse events were reported, and no adverse events led to discontinuation of the study medication. The most common adverse events (reported by 2 or more subjects who received ATI-450) observed during the trial were dizziness, headache, upper respiratory tract infection, constipation, nausea, and abdominal pain. All adverse events were mild. A trend of a decrease in absolute neutrophil count (ANC) was observed without correlated clinical sequelae. This effect is consistent with the pharmacodynamic profile of certain anti-TNF therapies1. Other laboratory findings were generally unremarkable.
In this trial, ATI-450 had dose proportional pharmacokinetics with a terminal half-life of 9-12 hours in the MAD cohort on day 7. The PK profile was not meaningfully affected when taking ATI-450 with a high fat meal. Further, co-administration of ATI-450 with methotrexate had little impact on methotrexate pharmacokinetics.
The pharmacodynamics of ATI-450 were evaluated by investigating the potential to inhibit production of key cytokines in ex vivo stimulated blood samples collected from subjects. At the 50mg BID dose (the dose with the highest degree of inhibition) at day 7 (12 hours post last dose): the mean trough drug levels were above the IC80 for TNFα, IL1β and IL8; IL6 plasma levels were inhibited by more than 50% for part of the dosing interval; and the mean trough drug level was above the IC80 for phosphorylation of Heat Shock Protein 27, a downstream substrate of MK2 (and marker of inhibition of the MK2 target).
“We believe these data support the progression of ATI-450 into Phase 2 clinical development,” said Dr. David Gordon, Chief Medical Officer of Aclaris. “The potential for an oral small molecule which suppresses multiple proinflammatory cytokines could be very meaningful for the treatment of a number of immuno-inflammatory diseases.”
Aclaris intends to initiate the first Phase 2 clinical trial in subjects with rheumatoid arthritis in the first half of 2020.
About ATI-450
ATI-450 is an investigational oral small molecule inhibitor of the p38α mitogen-activated protein kinase-activated protein kinase 2 (MK2) inflammatory signaling pathway. This pathway drives the expression of multiple cytokines, chemokines, matrix metalloproteases and other inflammatory signals. Key inflammatory cytokines driven by this pathway include tumor necrosis factor α (TNFα), interleukin-1α and -1β (IL1α and IL1β), and interleukin-6 (IL6). On the basis of this mechanism, Aclaris is developing ATI-450 as a potential treatment for immuno-inflammatory diseases.
3,02 US-Dollar (16:32:23
Das sollten wir Morgen wieder erreichen, wäre schön! Momentan wieder auf 2,21$ zurück!
Gruß aaahhh
Das sollten wir Morgen wieder erreichen, wäre schön! Momentan wieder auf 2,21$ zurück!
Gruß aaahhh
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