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Post by Clement on Jan 23, 2023 9:13:35 GMT -5
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Post by akemp3000 on Jan 23, 2023 9:16:41 GMT -5
One reason I enjoy this board is that it provides important educational background and updates for items like this. It remains puzzling as to how anyone could interpret progress achieving desired results as "horrible news". IMO, the path from nebulizers and dogs would seem to be a foundational requirement for a path to inhalation and humans. Others know more about this.
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Post by hellodolly on Jan 23, 2023 9:24:54 GMT -5
One reason I enjoy this board is that it provides important educational background and updates for items like this. It remains puzzling as to how anyone could interpret progress achieving desired results as "horrible news". IMO, the path from nebulizers and dogs would seem to be a foundational requirement for a path to inhalation and humans. Others know more about this. EXACTLY. The pre-clinical work, including the use of animals to follow up with post-mortem exams to analyze lung tissues, still remains the better option over humans. Nobody should take this news as anything less than steps required by the FDA to progress MNKD-101. I think readers often forget that MNKD (as do all Biotechs) must have FDA meetings in advance to discuss trial design, outcomes, etc. |
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Post by lennymnkd on Jan 23, 2023 9:25:18 GMT -5
It’s probably out of frustration we are not further along.
akemp
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Post by anderson on Jan 23, 2023 9:26:45 GMT -5
It doesn’t look like the Ph1 study was done with TechnoSphere (as a dry inhalation powder anyway). “The dosing study evaluated low, mid, and high doses of clofazimine administered using a jet nebulizer. The key safety findings of the study included: Clofazimine inhalation solution found to be generally well tolerated at daily doses of up to 90 mg” Yes it is the nebulizer. The drug was well under way when MNKD aquired QrumPharma in 2020. To reformulate it would have taken about a year and 10 million dollars, so right now we would be in phase 1. Also Tyvaso DPI had not been approved by the FDA yet and going the nebulizer route was probably a hedge to if they got turned down. So with those two factors in mind getting it to market ASAP and generating revenue was the priority. I am sure when the patent is about to expire, or someone else starts trying a DPI of clofazimine MNKD will follow through with developing it. Hopefully by that time there will be 3-4 more DPI drugs and FDA will get more relaxed on the Technosphere and make the process simpler for changing from nebulizer to DPI will |
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Post by hellodolly on Jan 23, 2023 9:27:51 GMT -5
It’s probably out of frustration we are not further along. akemp I agree, or a misunderstanding of what the FDA expects/requires. Besides, it's not like they've been sitting on their hands lately. In addition to the pre-clinical work with the pups, they've been just a little busy focusing on Tyvaso, expanding manufacturing capabilities, V-GO and more. |
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Post by anderson on Jan 23, 2023 9:29:59 GMT -5
This is great news and could be a huge win. Its a $10B market. A 10% capture would be very significant. I found it interesting that the concern has always been FDKP staying in the lung and causing long term issues. For this "Significant residual drug (Clofazimine) in lung tissue - is a good thing. It’s 3.7b in 2030. Here is the $3.7 bill in 2030 reference, Page 13
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Post by sayhey24 on Jan 23, 2023 9:32:44 GMT -5
It's looking like MC is about to get lucky again  Seriously, it appears Mannkind has control and could offer this opportunity to multiple competing companies with UTHR being one. The Tyvaso DPI partnership is a good one and UTHR deserves preferential consideration. That said, forthcoming partnerships could get better and better. It could be this also played into the decision regarding the manufacturing expansion by Mannkind and a new plant by UTHR. IMO, Mannkind already knows the future with Clofazamine and only has to wait on the final trials and approval to go to market. This is a really good update. When has MC been lucky in the past?  The last effort was "Seeing is Believing" and that crashed and burned. I am hoping we turned a corner in 2023. I agree MC is in control here. The royalties in this case should not be "low double digits". UTHR is well positioned for this and clearly knows how to sell. If MC could do a deal with another company and they offer 30% royalty and Martine offers 29%, I am going with UTHR. Lets hope for good news and see how well MC negotiates. |
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Post by hopingandwilling on Jan 23, 2023 9:47:39 GMT -5
kemp,
I admit that I made a bad choice using the word—horrible. But I stand by the fact they have not shared the full data from their
phase I trial. I also stand by that after apparently meeting with the FDA instead of announcing a Phase 2 trial they are spending money for an adaptive trial where obviously it will not involve human patients.
The stock opened down 2% this morning so it appear there are some who agree with me. I hope by the end of the day the stock goes up if they are owners of the stock.
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Post by mango on Jan 23, 2023 9:48:34 GMT -5
Kemp, you stated ---"Mannkind already knows the future with Clofazamine and only has to wait on the final trials and approval to go to market. This is a really good update." IMO, today's PR is horrible news for MannKind. This PR seems to indicate a classic case of kick the can down the road -aka -stalling! If you recall the MKC-101 Phase I clinical trial was reported on by Mannkind on September 6, 2022. This was five months ago. MannKind has reported they met with the FDA in late 2022. In September's report they stated--"Detail data finds will be presented in upcoming publications and scientific conferences. " Today's PR touts the clofazimine study published in a scientific journal and the data was gained from dogs and rats. One should be asking for the data from the handful of healthy patients where they claimed it was successful. What is really befuddling about today's PR there is no mention of the FDA and them approving MNKD for starting FDA approved protocols with humans suffering from this disease. This "adaptive" PR appear to be more dog and cat gathering info. Investor can hope this isn't another epi-pen disappointment after meeting with the FDA. Based on today's PR you might be right --"MannKind already know the future with Clofazamine" but it might not be what you want. I hope I'm wrong! The good news is you are wrong, as you hoped you be! Today’s news is a new milestone in MannKind history. MannKind has already completed a human Phase 1 clinical trial in healthy volunteers and it showed no safety signals and was well tolerated. The publication is of preclinical safety studies, including toxicokinetic analyses on beagle dogs. This is standard practice. Now, we are advancing to Phase 2/3 clinical trials in disease NTM volunteers. The two clinical trials are bridged together essentially to make for a speedier clinical trial and approval process since this is an extremely terrible rare disease and difficult to treat. I have no idea how you misinterpreted this as horrible news. |
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Post by Clement on Jan 23, 2023 9:58:55 GMT -5
The "adaptive Phase 2/3 study" announced today will definitely have human subjects and only human subjects.
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Post by cretin11 on Jan 23, 2023 10:28:39 GMT -5
It doesn’t look like the Ph1 study was done with TechnoSphere (as a dry inhalation powder anyway). “The dosing study evaluated low, mid, and high doses of clofazimine administered using a jet nebulizer. The key safety findings of the study included: Clofazimine inhalation solution found to be generally well tolerated at daily doses of up to 90 mg” Based on the paper I think the study was done using "beagle dogs". I am assuming they could not teach the beagle how to hold the TI inhaler with their paw. Then again maybe beagles "don't inhale". It does not mention that in the paper. journals.asm.org/doi/10.1128/aac.01144-22They should’ve enlisted Snoopy for the trial, he could learn how to use the inhaler and I strongly suspect he would also inhale. 😎 |
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Post by Thundersnow on Jan 23, 2023 11:21:27 GMT -5
I believe the Clofazimine drug is a JET NEBULIZER and not DPI.
Mike said several months ago they were going the NEB route and hopefully convert to a TI drug.
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Post by akemp3000 on Jan 23, 2023 11:51:47 GMT -5
With successful trials and even pending submittal and approval with a nebulizer, it should be much easier to convert to TS and inhalation. The FDA now appears to be up to speed on the technology Al Mann promoted so it shouldn't be as difficult as in the past. IMO, the nebulizer path may never reach the market for Clofazimine. Granted the word "should" doesn't always carry weight with the FDA. Just thinking this positions the company quite well for the next major TS partnership discussions.
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Post by phdedieu12 on Jan 23, 2023 14:17:33 GMT -5
Probably too early to rejoice, but so far so good. First acquisition for MC looks like a good one, and no partners! We get to keep it all
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Seriously, it appears Mannkind has control and could offer this opportunity to multiple competing companies with UTHR being one. The Tyvaso DPI partnership is a good one and UTHR deserves preferential consideration. That said, forthcoming partnerships could get better and better. It could be this also played into the decision regarding the manufacturing expansion by Mannkind and a new plant by UTHR. IMO, Mannkind already knows the future with Clofazamine and only has to wait on the final trials and approval to go to market. This is a really good update.
The last effort was "Seeing is Believing" and that crashed and burned.
