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MNKD-701
Feb 25, 2022 6:26:49 GMT -5
via mobile
Post by bthomas55ep on Feb 25, 2022 6:26:49 GMT -5
Did I catch in the earnings call that MNKD-701 had been cancelled? Was this going to be the UTHR second molecule? Any thoughts around this?
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Post by peppy on Feb 25, 2022 7:03:28 GMT -5
Did I catch in the earnings call that MNKD-701 had been cancelled? Was this going to be the UTHR second molecule? Any thoughts around this? I didn't think so, however, what do I know?  |
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Post by lennymnkd on Feb 25, 2022 7:29:11 GMT -5
No interest in which CGM we are giving out for free ! 🤔
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Post by peppy on Feb 25, 2022 7:33:51 GMT -5
No interest in which CGM we are giving out for free ! 🤔 I do not have the transcript. *For the people who can not get a CGM, (no insurance coverage?) * for physicians just prescribing afrezza, so they can see. To help physicians with prescribing for follow up doses. (?) |
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Post by lennymnkd on Feb 25, 2022 7:43:19 GMT -5
For whatever reason ,sounds good …part of what I’ve been waiting for 🤞
I don’t want to read to much into it , but I like it.
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Post by sayhey24 on Feb 25, 2022 7:49:06 GMT -5
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Post by peppy on Feb 25, 2022 7:59:05 GMT -5
Focusing on the first pink box, orphan lung disease. Our UTHR collaboration is strong and going forward and we're extremely excited to help patients as they get through this main decision. As I talked about, we're focused on building inventory and helping UT prepare for launch. On the pipeline, we've completed our first cohort in our SAD study.
The second cohort is about the start, and we expect to get SAD results in Q2 and MAD results in late Q2 or early Q3. MNKD-201 is the first time you're seeing this product. It's called Nintedanib, which is open as a brand. I'll talk about that later in the discussion but we're now revealing program. It's going to hopefully progress into Phase I in the near future. MNKD-501, I've talked about in the fifth set, and that's the TGF basis program, and both of these are in development and progressing into development milestones. We actually discontinued the development of Imatinib, AKA MannKind-701, as one of these we tried to do this year come in and bring more focus and get rid of distracting things that weren't going to move forward in the way that we expected. And that also led us into Afrezza. ======================================================================================= What is "SAD results in Q2 and MAD results in late Q2 or early Q3. MNKD-201 is the first time you're seeing this product. It's called Nintedanib, which is open as a brand." ? mango who is behind the SAD and MAD trials? Can you help? added, -INDICATIONS AND USAGE--------------------------- OFEV is a kinase inhibitor indicated for: ï‚· Treatment of idiopathic pulmonary fibrosis (IPF). (1.1) ï‚· Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (1.2) ï‚· Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). (1.3 www.accessdata.fda.gov/drugsatfda_docs/nda/2020/205832Orig1s013.pdf |
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Post by Clement on Feb 25, 2022 8:29:21 GMT -5
SAD single ascending dose
MAD multiple ascending dose
first-in-human (FIH) studies usually
safety and tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and maximum tolerated dose (MTD).
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Post by peppy on Feb 25, 2022 8:32:08 GMT -5
No interest in which CGM we are giving out for free ! 🤔 However, we did launch a campaign in Q4 called Seeing is Believing, where we provided free CGMs to doctors who didn't write Afrezza consistently. And in that pilot, we saw about 45% of the target actually opt into the program, and that group grew three times national average versus what we saw in Q4. We also lost a primary care pilot in Q4, where we're focused on the sub part of the country with 25 additional reps focused on helping drive success in primary care, where there is very low awareness of Afrezza adoption or trial. We also just recently filed at clinicaltrials.gov, our ABC trial, Afrezza Basal Combination, which was also previously referred to as the pump-switch trial. |
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Post by Clement on Feb 25, 2022 8:33:48 GMT -5
MNKD-201
Search on clinicaltrials.gov and you will find lots of studies on nintedanib.
I assume what makes it a good target for Technosphere is that the bioavailability of nintedanib by oral administration is only 4.7%. Also, MNKD is focused on IPF for this one and lung delivery is ideal.
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Post by peppy on Feb 25, 2022 8:39:44 GMT -5
MNKD-201 Search on clinicaltrials.gov and you will find lots of studies on nintenamib. I assume what makes it a good target for Technosphere is that the bioavailability of nintenamib by oral adminitration is on 4.7%. over my head as usual, is Nintenamib the second UTHR molecule? or a MNKD pipeline molecule? The sentence does not make it clear to me. "Our UTHR collaboration is strong and going forward and we're extremely excited to help patients as they get through this main decision. As I talked about, we're focused on building inventory and helping UT prepare for launch. On the pipeline, we've completed our first cohort in our SAD study." "The second cohort is about the start, and we expect to get SAD results in Q2 and MAD results in late Q2 or early Q3. MNKD-201 is the first time you're seeing this product. It's called Nintedanib, which is open as a brand. I'll talk about that later in the discussion but we're now revealing program." |
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Post by Clement on Feb 25, 2022 8:44:55 GMT -5
MNKD-201 Search on clinicaltrials.gov and you will find lots of studies on nintenamib. I assume what makes it a good target for Technosphere is that the bioavailability of nintenamib by oral adminitration is on 4.7%. over my head as usual, is Nintenamib the second UTHR molecule? or a MNKD pipeline molecule? The sentence does not make it clear to me. "Our UTHR collaboration is strong and going forward and we're extremely excited to help patients as they get through this main decision. As I talked about, we're focused on building inventory and helping UT prepare for launch. On the pipeline, we've completed our first cohort in our SAD study." "The second cohort is about the start, and we expect to get SAD results in Q2 and MAD results in late Q2 or early Q3. MNKD-201 is the first time you're seeing this product. It's called Nintedanib, which is open as a brand. I'll talk about that later in the discussion but we're now revealing program." I think the latter. I think the paragraph break should be just before "On the pipeline". |
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Post by peppy on Feb 25, 2022 8:45:36 GMT -5
ok, never mind, here it is. doh.  |
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MNKD-701
Feb 25, 2022 9:08:06 GMT -5
via mobile
Post by sweedee79 on Feb 25, 2022 9:08:06 GMT -5
Ok.. so no word on UT second molecule?
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Post by sweedee79 on Feb 25, 2022 9:19:25 GMT -5
Just read transcript.. Mnkd 701 discontinued for this year so they can focus on other things is what it sounds like..
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