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Post by centralcoastinvestor on Jul 19, 2019 16:08:25 GMT -5
I saw this posted on StockTwits by itoprag. From the clinical trials website it shows that the TreT study will begin in August 2019. That must mean that the TreT manufacturing line in Danbury is good to go. Overall this is good news for MannKind. I have a question for the board. This is showing as a Phase 1b study. I thought we could move directly into Phase 3. Or do we complete the Phase 1b and move directly to Phase 3 after that. I am hoping that those more knowledgeable can share. clinicaltrials.gov/ct2/show/NCT03950739?term=united+therapeutics&rank=3 |
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Post by mytakeonit on Jul 19, 2019 16:32:06 GMT -5
I believe that going into Phase 3 was the pediatric study. But, wine effects still linger in the morning.
But, that's mytakeonit
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Post by harryx1 on Jul 19, 2019 16:40:59 GMT -5
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Post by goyocafe on Jul 19, 2019 17:18:40 GMT -5
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Let's get 'er dun!
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Post by rtmd on Jul 19, 2019 17:32:47 GMT -5
I saw this posted on StockTwits by itoprag. From the clinical trials website it shows that the TreT study will begin in August 2019. That must mean that the TreT manufacturing line in Danbury is good to go. Overall this is good news for MannKind. I have a question for the board. This is showing as a Phase 1b study. I thought we could move directly into Phase 3. Or do we complete the Phase 1b and move directly to Phase 3 after that. I am hoping that those more knowledgeable can share. clinicaltrials.gov/ct2/show/NCT03950739?term=united+therapeutics&rank=3That does seem strange. As I understood it, Mannkind already completed the phase 1 study. |
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Post by goyocafe on Jul 19, 2019 20:09:05 GMT -5
I saw this posted on StockTwits by itoprag. From the clinical trials website it shows that the TreT study will begin in August 2019. That must mean that the TreT manufacturing line in Danbury is good to go. Overall this is good news for MannKind. I have a question for the board. This is showing as a Phase 1b study. I thought we could move directly into Phase 3. Or do we complete the Phase 1b and move directly to Phase 3 after that. I am hoping that those more knowledgeable can share. clinicaltrials.gov/ct2/show/NCT03950739?term=united+therapeutics&rank=3That does seem strange. As I understood it, Mannkind already completed the phase 1 study.
In single ascending dose studies, small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time to confirm safety.[6][9] Typically, a small number of participants, usually three, are entered sequentially at a particular dose.[1] If they do not exhibit any adverse side effects, and the pharmacokinetic data are roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given a higher dose. If unacceptable toxicity is observed in any of the three participants, an additional number of participants, usually three, are treated at the same dose.[1] This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the maximum tolerated dose (MTD)). If an additional unacceptable toxicity is observed, then the dose escalation is terminated and that dose, or perhaps the previous dose, is declared to be the maximally tolerated dose. This particular design assumes that the maximally tolerated dose occurs when approximately one-third of the participants experience unacceptable toxicity. Variations of this design exist, but most are similar.[1]
Multiple ascending dose (Phase Ib)
Multiple ascending dose studies investigate the pharmacokinetics and pharmacodynamics of multiple doses of the drug, looking at safety and tolerability. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to a predetermined level.[6][9]
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Post by rtmd on Jul 19, 2019 22:34:56 GMT -5
I saw this posted on StockTwits by itoprag. From the clinical trials website it shows that the TreT study will begin in August 2019. That must mean that the TreT manufacturing line in Danbury is good to go. Overall this is good news for MannKind. I have a question for the board. This is showing as a Phase 1b study. I thought we could move directly into Phase 3. Or do we complete the Phase 1b and move directly to Phase 3 after that. I am hoping that those more knowledgeable can share. clinicaltrials.gov/ct2/show/NCT03950739?term=united+therapeutics&rank=3That does seem strange. As I understood it, Mannkind already completed the phase 1 study. Oh, I see: " In this Phase 1b safety and tolerability study, patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily [QID]) will be evaluated after switching to a corresponding dose of TreT. Patients will undergo PK assessments, safety assessments, a 6-Minute Walk Test (6MWT), and questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact. Following 3 weeks of treatment with TreT, patients will be offered the opportunity to participate in the Optional Extension Phase until the study terminates or the drug/device becomes commercially available." As I recall, Mannkind did their phase 1 on healthy subjects, |
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Post by mnholdem on Jul 20, 2019 8:41:16 GMT -5
Pre-clinical testing demonstrated that TreT is able to safely deliver a higher dose per inhale than Tyvaso so it is expected that less inhalations by the patient will be needed with Tret treatment. The Phase 1b study is intended to confirm the pre-clinical data and one of the secondary outcomes is patient satisfaction with the TreT deliver using the smaller device.
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Post by centralcoastinvestor on Jul 20, 2019 8:56:46 GMT -5
Pre-clinical testing demonstrated that TreT is able to safely deliver a higher dose per inhale than Tyvaso so it is expected that less inhalations by the patient will be needed with Tret treatment. The Phase 1b study is intended to confirm the pre-clinical data and one of the secondary outcomes is patient satisfaction with the TreT deliver using the smaller device. So once the 1b study is complete, can UTHR move directly to filing an NDA for drug approval? It appears that they can skip a Phase 2 and Phase 3 study. If so, then that sets up a major milestone event for MannKind next summer with possible FDA approval of TreT. |
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Post by Clement on Jul 21, 2019 12:52:44 GMT -5
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Post by agedhippie on Jul 21, 2019 15:04:39 GMT -5
Will the second trial need to be rerun with UTHR's API (maybe they used UTHR's API in the original trial)? |
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Post by pantaloons on Aug 4, 2019 9:13:52 GMT -5
I'm wondering if the blackbox label on Afrezza will be impacted at all by the safety trial results from the TrepT study.
Namely, if the TrepT study can somehow alleviate potential concern regarding inhalation of the Technosphere delivery device, can this data be used directly to improve the blackbox warning on Afrezza? Admittedly, I'm not familiar with how such a study would be designed and implemented.
Notable to consider is the fact that the patient population (indications) for TrepT and Afrezza are distinctly different. Perhaps, while any pulmonary side effects may be tolerated for PAH patients using TrepT, pulmonary side effects would not be tolerated for diabetics using Afrezza. Hence, a blackbox label on Afrezza but none for TrepT. Stated another way, the risk/benefit profiles when considering patient population is different for TrepT vs. Afrezza and therefore the blackbox label would be employed for one drug but not the other. This is just a speculation.
Nonetheless, I imagine the safety data from the TrepT trials would be valuable to improving the safety concerns regarding Afrezza.
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Post by uvula on Aug 4, 2019 10:32:09 GMT -5
Sounds like a stretch. The blackbox warning is for technosphere particles plus insulin. TreT of course has no insulin.
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Post by letitride on Aug 4, 2019 12:09:16 GMT -5
Sounds like a stretch. The blackbox warning is for technosphere particles plus insulin. TreT of course has no insulin. Some could make an argument that human insulin isn't the questionable part its the delivery vehicle that needs confirmation. |
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Post by sportsrancho on Aug 10, 2019 19:38:38 GMT -5
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