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Post by caesar on Jun 29, 2023 14:01:48 GMT -5
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Post by hellodolly on Jun 29, 2023 14:21:08 GMT -5
I think this should have it's own thread to discuss the science, etc. [Your wish is my command...
-BD] |
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Post by hellodolly on Jun 29, 2023 14:40:57 GMT -5
In short, covered below, 590 mg of Amikacin is currently inhaled but a large accumulation of the drug quickly escalates and patients interrupt their treatment due to the side effects. MNKD has formulated their drug in which the patient can take 30 mg doses of Clofazimine for 28 days and take a 60 day drug "holiday" to let clofazimine do its job. After the 60 day holiday, another 28 day regimen is conducted and the treatment is complete. I like this so far. I guess nebulizers won't be an issue? "The observation of dose-dependent accumulation in the Phase 1 study supports the use of flexible dosing regimens consisting of relatively short dosing periods followed by longer drug holidays during which clofazimine remains present and active in the lung. Overall, these Phase 1 safety and pharmacokinetic data provide a basis for late-stage clinical development of inhaled clofazimine as a treatment for pulmonary NTM infections. Inhaled antibiotics have been associated with respiratory side effects [11]. As noted above, cough and bronchospasm are commonly reported in patients with pulmonary NTM disease receiving inhaled amikacin. In some cases, such adverse events lead to interruption of inhaled amikacin for up to 14 days or reduction in dosing frequency from every day to 3 days a week until resolution of symptoms. Additional warnings and precautions included in the prescribing information for inhaled amikacin include ototoxicity, nephrotoxicity, and neuromuscular blockade. The approved dose of inhaled amikacin, 590 mg, is considerably higher than the doses of inhaled clofazimine (30 to 90 mg in the Phase 1 study), reflecting the lower MIC and higher potency of clofazimine against NTM infections. Collectively, the preliminary evidence from the Phase 1 study suggests that inhaled clofazimine may be well tolerated in the lung and systemically. The rate of respiratory and other side effects will be monitored in the planned Phase 2/3 clinical trial." |
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Post by wyattdog on Oct 25, 2023 17:44:02 GMT -5
Posted on LinkedIn: View profile for Thomas Hofmann
Thomas Hofmann
Chief Scientific Officer at MannKind Corporation
2h
Inhaled Clofazimine patent issued
Yesterday was a great day for the team at Mannkind, and potentially for patients suffering from NTM lung infections - our US patent was issued, and will help protect this simple and useful idea. Thank you to all who contributed, and looking forward to see MNKD-101 tested in clinical studies for NTM.
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Jakko van Ingen
Jakko van Ingen
MD, PhD, consultant clinical microbiologist, head of mycobacteriology
1h
Great news!!
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Vikki Brandi, Doctorate of Health Science, PA
Vikki Brandi, Doctorate of Health Science, PA
49m
Great milestone - congrats!
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Azadeh A.
Azadeh A.
1h
Congratulations!
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Heiner Markhoff
Heiner Markhoff
Board Member, Investor, Retired GE Group Vice President
7m
Herzlichen Glückwunsch!
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Dr Mridul Majumder
Dr Mridul Majumder
Pharmaceutical Professional I Inhalation I Material Science I Contract Services I R&D I GMP I
56m
Congratulations
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Sara McLenighan
Sara McLenighan
Vice President of National Sales
54m
Congratulations Thomas! Very exciting 👏🏻
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Steve Palmisano, ISMPP CMPP
Steve Palmisano, ISMPP CMPP
EVP, Publication Services (Business Development, Med Affairs, Medical Publications, Scientific Platforms, Procurement, Innovation, AI, HC Communications, Management, and Strategy)
1h MD, PhD, consultant clinical microbiologist, head of mycobacteriology
1h
Great news!!
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Vikki Brandi, Doctorate of Health Science, PA
Vikki Brandi, Doctorate of Health Science, PA
49m
Great milestone - congrats!
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Azadeh A.
Azadeh A.
1h
Congratulations!
Like
Reply
Heiner Markhoff
Heiner Markhoff
Board Member, Investor, Retired GE Group Vice President
7m
Herzlichen Glückwunsch!
Like
Reply
Dr Mridul Majumder
Dr Mridul Majumder
Pharmaceutical Professional I Inhalation I Material Science I Contract Services I R&D I GMP I
56m
Congratulations
Like
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Sara McLenighan
Sara McLenighan
Vice President of National Sales
54m
Congratulations Thomas! Very exciting 👏🏻
Like
Reply
Steve Palmisano, ISMPP CMPP
Steve Palmisano, ISMPP CMPP
EVP, Publication Services (Business Development, Med Affairs, Medical Publications, Scientific Platforms, Procurement, Innovation, AI, HC Communications, Management, and Strategy)
1h
Congrats , Tom! Great news for your team and patients!!
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Post by cretin11 on Oct 27, 2023 10:17:26 GMT -5
Certainly seems like positive news, strange that it had no discernable impact on our share price. Perhaps it was known to be happening and thus zero surprise to anyone.
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Post by hellodolly on Oct 28, 2023 6:55:34 GMT -5
Certainly seems like positive news, strange that it had no discernable impact on our share price. Perhaps it was known to be happening and thus zero surprise to anyone. Honestly, across the whole sector...positive news doesn't move the needle too much. In fact, in some announcements the share price has been going down. The entire space has valuations being decimated and reset. So many early stage and commercial stage bios have sunk below $1, even with great newsworthy announcements. |
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Post by Clement on Oct 30, 2023 5:50:09 GMT -5
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Post by hellodolly on Oct 30, 2023 6:43:17 GMT -5
MNKD-101 has been designated by the FDA as both an orphan drug and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections.
For a drug product to be designated a QIDP, the sponsor is required to demonstrate that the drug is an “antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections.”3 In its designation request, a sponsor requesting a QIDP designation may also include documentation that the product is intended to treat an “antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens” or a qualifying pathogen included in 21 CFR 317.2; however, such documentation is not required. 4 Source:https://www.fda.gov/media/148480/download QIDP designation confers particular advantages, including priority review by the US Food and Drug Administration (FDA) and fast-track designation, which can accelerate development of a product, as well as an additional five years' market exclusivity if a product is licensed.
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Post by cretin11 on Oct 30, 2023 7:46:44 GMT -5
Good PR today, hopefully it continues and we get some hype and momentum on this front.
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Post by MnkdWASmyRtrmntPlan on Oct 30, 2023 9:08:55 GMT -5
Yes, priority review and fast-track designation with a 15 year patent! ... great news.
So, with Phase 2/3 study beginning 1st half of 2024, what is the Proboards estimate of when sales will begin (product launch date)? First half of 2025?
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Post by hellodolly on Oct 30, 2023 9:30:41 GMT -5
Yes, priority review and fast-track designation with a 15 year patent! ... great news. So, with Phase 2/3 study beginning 1st half of 2024, what is the Proboards estimate of when sales will begin (product launch date)? First half of 2025? Mike said the study was slated to last for six months and that was enough to satisfy the FDA requirements, based on the treatment regimen of 28 days on, 60 days off, 28 days on 60 days off. That's exactly a 6th month course of treatment. Of course, stars aligning, not all patients will enroll and start at the same time so, he may have been referring to the individual patient partaking in the study for 6 months, plus follow up. My guess is last half of 2025 (18 months to 24 months out). We will have an international distribution partner named, somewhere out of Japan he mentioned, and my guess a partner in the US?? Manufacturing, warehouse, distribution, marketing (although I don't think we need much with NTM), and we can do this alone, too. Drug launches are not our specialty so, right now I'd be open to a US partner like UTHR since this is a lung disease and in the UTHR wheel-house. |
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Post by uvula on Oct 30, 2023 9:32:08 GMT -5
Is this still the nebulizer version? If so what is the plan to technosphere it?
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Post by prcgorman2 on Oct 30, 2023 10:34:01 GMT -5
Yes, nebulizer it appears given the patent is for an inhalable "solution". I speculate they get up and running with this and only convert to TS if/when it makes economic sense. i.e., need to make sure using TS gains some user or economic benefit of using TS version versus solution, might need new patent(s), will need drug dev, FDA re-approval for a different form (similar to Tyvaso DPI course as compared to Tyvaso), testing, et cetera.
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Post by MnkdWASmyRtrmntPlan on Oct 30, 2023 10:38:40 GMT -5
Yes, Uvula, nebulizer.
Yeah, I wonder how much longer it will take to make a DPI version and get it up for sale?
There is concern about systemic problems from the large amount of clofazimine.
DPI should be able to use less clofazimine, so less side-effects.
The Journal report said that "The rate of respiratory and other side effects will be monitored in the planned Phase 2/3 clinical trial."
That trial should indicate the amount of side-effects and how much benefit a DPI version would have.
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Post by MnkdWASmyRtrmntPlan on Oct 30, 2023 10:54:07 GMT -5
Thanks for your input, HelloDolly. Yeah, I was afraid it might be second-half of 2025. So, if MNKD did decide to go on to follow-up with a DPI version, that would probably be another couple years after that (late 2027) before it would be sold.
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