MannKind Receives U.S. FDA Fast Track Designation

[casualinvestor]

investors.mannkindcorp.com/news-releases/news-release-details/mannkind-successfully-completes-phase-1-study-inhaled

In the SAD portion of the study, 24 adults were enrolled in one of three cohorts (n = 8 per cohort) that received a single inhaled dose of 30 mg, 60 mg
or 90 mg clofazimine, respectively. Participants resided at the clinical research unit until day 5 post-dose, during which time they were evaluated for
safety and samples were collected for PK assessment. Participants returned on days 8 and 15 for additional safety assessments and sample
collection. During the MAD portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30
mg or 90 mg clofazimine for a seven-day period. Participants resided at the clinical research unit until day 8 post-dose, during which time they were
evaluated for safety and samples were collected for PK assessment. Participants returned on days 15 and 36 for additional safety assessments and
sample collection.

[agedhippie]

May 25, 2024 11:57:11 GMT -5 casualinvestor said:

investors.mannkindcorp.com/news-releases/news-release-details/mannkind-successfully-completes-phase-1-study-inhaled

In the SAD portion of the study, 24 adults were enrolled in one of three cohorts (n = 8 per cohort) that received a single inhaled dose of 30 mg, 60 mg
or 90 mg clofazimine, respectively. Participants resided at the clinical research unit until day 5 post-dose, during which time they were evaluated for
safety and samples were collected for PK assessment. Participants returned on days 8 and 15 for additional safety assessments and sample
collection. During the MAD portion of the study, 16 adults were enrolled in one of two cohorts (n = 8 per cohort) that received a daily inhaled dose of 30
mg or 90 mg clofazimine for a seven-day period. Participants resided at the clinical research unit until day 8 post-dose, during which time they were
evaluated for safety and samples were collected for PK assessment. Participants returned on days 15 and 36 for additional safety assessments and
sample collection.

Thanks. I am not sure how I missed that!

The trial doesn't seem to be registered on the Clinical Trials web site even if I manually look through all completed clofazimine trials which is a bit weird. They PR says detailed data findings will be presented in upcoming publications and scientific conferences, but it doesn't seem to have happened as far as I can see. That's not a big deal though as it would be superseded by the current trial results anyway.

[celo]

The lowest dosage for oral clofazimine to minimize side effects and still have a positive effect is 200 mg. Good to see they are looking for desired effect in the 30-90 mg range.

[jkendra]

x.com/AGLizMurrill/status/1849149641591296451



Would love to know how inhaled Clofazamine would do against this strain.

[jkendra]

BREAKING: I am suing @alimayorkas @dhsgov after a Chinese national who illegally entered the United States was found in Louisiana with a rare, aggressive, & drug-resistant form of Tuberculosis, threatening the health & safety of the people of Louisiana & America.

aglizmurrill.com/Article/169

[agedhippie]

Oct 23, 2024 14:30:31 GMT -5 jkendra said:

x.com/AGLizMurrill/status/1849149641591296451



Would love to know how inhaled Clofazamine would do against this strain.

It should work as Clofazamine is a third line drug for MDR-TB. The classification she is talking about is where the drug is resistant to (a) isoniazid, rifampin, and a fluoroquinolone or (b) isoniazid, rifampin, and a second-line injectable (amikacin, capreomycin, and kanamycin). There are ten other second-line drugs they would probably prefer to Clofazamine though. Contrary to the press release this is rare but hardly unknown. New York has about 70 of these cases a year.

[prcgorman2]

Oct 23, 2024 16:39:20 GMT -5 agedhippie said:

Oct 23, 2024 14:30:31 GMT -5 jkendra said:

x.com/AGLizMurrill/status/1849149641591296451



Would love to know how inhaled Clofazamine would do against this strain.

It should work as Clofazamine is a third line drug for MDR-TB. The classification she is talking about is where the drug is resistant to (a) isoniazid, rifampin, and a fluoroquinolone or (b) isoniazid, rifampin, and a second-line injectable (amikacin, capreomycin, and kanamycin). There are ten other second-line drugs they would probably prefer to Clofazamine though. Contrary to the press release this is rare but hardly unknown. New York has about 70 of these cases a year.

You make it sound like the lawsuit was almost purely motivated by politics.  Well, maybe I'm just projecting my own thoughts there.

[agedhippie]

Oct 23, 2024 21:33:44 GMT -5 prcgorman2 said:

You make it sound like the lawsuit was almost purely motivated by politics.  Well, maybe I'm just projecting my own thoughts there.

You may very well say that. I couldn't possibly comment!

[cretin11]

Oct 23, 2024 21:33:44 GMT -5 prcgorman2 said:

Oct 23, 2024 16:39:20 GMT -5 agedhippie said:

Contrary to the press release this is rare but hardly unknown. New York has about 70 of these cases a year.

You make it sound like the lawsuit was almost purely motivated by politics.  Well, maybe I'm just projecting my own thoughts there.

prc once in a while your search for finding droids (or however you phrase it) hits upon something accurate!  (and i think you can even remove "almost" from your statement)  

[jkendra]

www.barrons.com/news/tuberculosis-cases-hit-record-high-who-a476ff4d


Tuberculosis Cases Hit Record High: WHO

By AFP - Agence France Presse

October 30, 2024


A record 8.2 million new tuberculosis cases were diagnosed worldwide last year, the World Health Organization said -- the highest number since it began global TB monitoring in 1995.
The WHO said its Global Tuberculosis Report 2024, released Tuesday, highlights "mixed progress in the global fight against TB, with persistent challenges such as significant underfunding".

While the number of TB-related deaths declined from 1.32 million in 2022 to 1.25 million last year, the total number of people contracting the infectious disease increased from 7.5 million to 8.2 million.
However, not all new cases are diagnosed, and WHO estimates that around 10.8 million people actually contracted the disease last year.
"The fact that TB still kills and sickens so many people is an outrage, when we have the tools to prevent it, detect it and treat it," WHO chief Tedros Adhanom Ghebreyesus said in a statement.
"WHO urges all countries to make good on the concrete commitments they have made to expand the use of those tools, and to end TB."
The increase in cases between 2022 and 2023 largely reflects global population growth, the report said.

Last year the TB incidence rate was 134 new cases per 100,000 people -- a 0.2-percent increase compared to 2022.
The disease disproportionately affects people in 30 high-burden countries.
And five countries -- India, Indonesia, China, Philippines and Pakistan -- account for more than half of the global TB burden, with more than a quarter of the cases found in India alone.

According to the report, 55 percent of people who developed TB were men, 33 percent were women and 12 percent were children and young adolescents.
A preventable and curable disease, TB is caused by bacteria and most often affects the lungs. It is spread through the air when people with lung TB cough, sneeze or spit.
The WHO said a significant number of new TB cases were driven by five major risk factors: undernutrition, HIV infection, alcohol use disorders, diabetes, and, especially among men, smoking.
"Global milestones and targets for reducing the TB disease burden are off-track," the WHO said.

Only $5.7 billion of the $22 billion global annual funding target for TB prevention and care was available last year.
"In 2023, TB probably returned to being the world's leading cause of death from a single infectious agent, following three years in which it was replaced by coronavirus disease (Covid-19)," the WHO added.

[Clement]

^ Does MNKD have an interest in tuberculosis?

[jkendra]

I know NTM is more prevalent but would be interesting to see how inhaled Clofazimine stacks up against TB.