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Post by boca1girl on Sept 30, 2021 7:32:59 GMT -5
finance.yahoo.com/news/merck-buy-acceleron-11-5-105259037.htmlCould this be the reason why both UT and MNKD have been selling off lately? Merck buys Acceleron. Cambridge, Massachusetts-based Acceleron focuses on therapeutics that treat cardiovascular and other blood-related disorders. Its sotatercept drug, which is currently in a late-stage study, is aimed at treating a rare cardiovascular disease called pulmonary arterial hypertension (PAH), a type of high blood pressure that affects the lungs.
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Post by Clement on Sept 30, 2021 7:52:21 GMT -5
I'm looking at this phase 2a trial that is ongoing with an estimated completion date of December 31, 2022. I would guess, with application and review, the earliest approval would be January of 2024 (and maybe add a year or two to that). clinicaltrials.gov/ct2/show/NCT03738150?term=sotatercept&draw=2&rank=4Study Design Go to sections Study Type : Interventional (Clinical Trial) Actual Enrollment : 21 participants Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial Hypertension Actual Study Start Date : May 1, 2019 Estimated Primary Completion Date : December 31, 2021 Estimated Study Completion Date : December 31, 2022 |
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Post by uvula on Sept 30, 2021 7:54:50 GMT -5
Maybe another reason uthr paid $100M for the speedy review voucher.
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Post by peppy on Sept 30, 2021 7:58:27 GMT -5
I'm looking at this phase 2a trial that is ongoing with an estimated completion date of December 31, 2022. I would guess, with application and review, the earliest approval would be January of 2024 (and maybe add a year or two to that). clinicaltrials.gov/ct2/show/NCT03738150?term=sotatercept&draw=2&rank=4Study Design Go to sections Study Type : Interventional (Clinical Trial) Actual Enrollment : 21 participants Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial Hypertension Actual Study Start Date : May 1, 2019 Estimated Primary Completion Date : December 31, 2021 Estimated Study Completion Date : December 31, 2022 Martine, bet them to the plate. |
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Post by beardawg on Sept 30, 2021 13:01:57 GMT -5
Why does this change anything? Wasn't this drug already in the works before Merck bought it? The competition has always been there.
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Post by boca1girl on Sept 30, 2021 15:30:19 GMT -5
National news coverage. The Merck CEO was on CNBC talking about the buyout and PAH. It caught my attention, that’s for sure!
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Post by mannmade on Sept 30, 2021 15:40:17 GMT -5
Why does this change anything? Wasn't this drug already in the works before Merck bought it? The competition has always been there. What changes is the sales and marketing clout and the level of competition in distribution channels. Makes for a tougher competitor imho... |
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Post by Clement on Sept 30, 2021 15:48:04 GMT -5
Like Peppy said, Martine beat them to the plate.
By two years or more.
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Post by itellthefuture777 on Sept 30, 2021 16:10:59 GMT -5
Wish Martine would kick start more items in the pipe and shut down these Seeking Alpha pricks
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Post by mango on Sept 30, 2021 17:45:35 GMT -5
This is an injectable for WHO Group 3.
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Post by sr71 on Oct 1, 2021 11:43:34 GMT -5
With a two year headstart, it's hard to imagine that Tyvaso DPI (by then likely an established inhalable) would then subsequently lose market share to an injectable, unless the injectable could prove superiority in the trial(s).
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Post by akemp3000 on Oct 2, 2021 7:30:09 GMT -5
Out of curiosity, how might an injectable delivery method prove superiority over inhalation for deep lung indications? This is not to inquire about a different drug, just the application difference. The first initial thought was that if it's a different drug that eventually proves superiority, then they should be in talks with Mannkind...unless prohibited by the UTHR agreement.
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Post by mango on Oct 2, 2021 11:20:55 GMT -5
From the Phase 2 trial • Sotatercept, a novel fusion protein, binds activins and growth differentiation factors in the attempt to restore balance between growth-promoting and growth-inhibiting signaling pathways. • The greater degree of reduction in pulmonary vascular resistance as compared with placebo was seen at both dose levels of sotatercept, with the higher dose resulting in a 34% reduction from baseline. • Thrombocytopenia and an increased hemoglobin level were the most common hematologic adverse events. One patient in the higher-dose sotatercept group died from cardiac arrest. • Thrombocytopenia was the most common adverse event of special interest but was not associated with bleeding events in this trial; all the events were reversible after delay, reduction, or discontinuation of sotatercept or placebo. The observed increases in hemoglobin levels are consistent with the erythropoietic effects of sotatercept seen in previous clinical trials.18-24 Mean hemoglobin levels remained elevated throughout the treatment period in both sotatercept groups, and 3 patients discontinued sotatercept or placebo in accordance with the protocol owing to hemoglobin levels that exceeded the prespecified safety margin of 18 g per deciliter. • This trial has some limitations. First, as with other phase 2 trials, the sample size was relatively small; however, allowances made for expected dropout rates in each treatment group were sufficient to show improvements with respect to the primary and secondary end points. Second, the duration of the trial was brief at 24 weeks, and the longer-term effects of sotatercept in this clinical context have not been established. Third, the trial was not designed to study the effects of sotatercept on clinical outcomes, including mortality, and this would be important to address in future trials. • Sotatercept is a first-in-class therapeutic fusion protein that targets an imbalance in activin–growth differentiation factor and BMP pathway signaling. In this trial, treatment with sotatercept reduced pulmonary vascular resistance among patients with pulmonary arterial hypertension who were receiving stable background therapy, including prostacyclin infusion therapy. Concordant improvements from baseline in 6-minute walk distance and NT-proBNP levels were also observed. Additional trials, including a phase 3 trial, are ongoing or planned. Further reading: www.nejm.org/doi/full/10.1056/NEJMoa2024277 |
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Post by ktim on Oct 6, 2021 14:47:05 GMT -5
Out of curiosity, how might an injectable delivery method prove superiority over inhalation for deep lung indications? This is not to inquire about a different drug, just the application difference. The first initial thought was that if it's a different drug that eventually proves superiority, then they should be in talks with Mannkind...unless prohibited by the UTHR agreement. If it were an injectable that provided stable control for 24 hours or more without undesirable side effects, I could certainly see the benefit to that. Even if some extended action molecule is introduced there may still be role for fast acting inhaled... just like T1's often using both fast and longer action insulin. Seems PAH is still far from being a truly well treated disease, so more treatment options likely hold potential for improved outcomes. We are partnered with the leader in the space, so at least we've got a gorilla in the fight for us. |
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