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Post by hellodolly on Sept 6, 2022 5:17:21 GMT -5
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101) and is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program.
Clofazimine is being developed as an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease. NTM lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000 people in the U.S. are living with NTM lung disease, and it is on the rise growing 8% each year with women, the elderly, and those with underlying lung conditions at greatest risk. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections.
“There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease,” said Michael Castagna, PharmD, Chief Executive Office of MannKind Corporation. “As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients.”
Study MKC-CI -001 was a Phase I randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101 in healthy volunteers. 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 over a seven-day period
No lab abnormalities, QT prolongation, or serious adverse events identified
“The safety and tolerability results for inhaled clofazimine are encouraging and we look forward to advancing the nebulized formulation of clofazimine to the next phase of development,” said Thomas Hofmann, Chief Scientific Officer of MannKind Corporation. “Clofazimine presented as being very lipophilic and demonstrated the expected therapeutic plasma concentrations we were targeting. In future studies, we plan to evaluate the potential for MNKD-101 to produce drug levels that exceed the minimum inhibitory concentration in the lung beyond the treatment period.”
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.
Additional data collected during the MKC-CI-001 study is currently undergoing final analysis. Detailed data findings will be presented in upcoming publications and scientific conferences.
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Post by Thundersnow on Sept 6, 2022 5:43:29 GMT -5
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101) and is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program. Clofazimine is being developed as an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease. NTM lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000 people in the U.S. are living with NTM lung disease, and it is on the rise growing 8% each year with women, the elderly, and those with underlying lung conditions at greatest risk. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. “There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease,” said Michael Castagna, PharmD, Chief Executive Office of MannKind Corporation. “As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients.” Study MKC-CI -001 was a Phase I randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101 in healthy volunteers. 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 over a seven-day period No lab abnormalities, QT prolongation, or serious adverse events identified “The safety and tolerability results for inhaled clofazimine are encouraging and we look forward to advancing the nebulized formulation of clofazimine to the next phase of development,” said Thomas Hofmann, Chief Scientific Officer of MannKind Corporation. “Clofazimine presented as being very lipophilic and demonstrated the expected therapeutic plasma concentrations we were targeting. In future studies, we plan to evaluate the potential for MNKD-101 to produce drug levels that exceed the minimum inhibitory concentration in the lung beyond the treatment period.” 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. Additional data collected during the MKC-CI-001 study is currently undergoing final analysis. Detailed data findings will be presented in upcoming publications and scientific conferences. So MNKD is entering the nebulizer market. Do we know if MNKD is manufacturing the product or are they outsourcing? Was hoping it was a DPI but I believe Mike said a few Qtrs ago it wasn't and hoping it would convert into a DPI. MNKD signed UTHR partnership 90 days after Phase 1 approval of TreT (Tyvaso DPI). Will it happen this time?? Does anyone know the market size of Clofazamine? Is this the drug Boehringer Ingelheim owns?? |
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Post by boytroy88 on Sept 6, 2022 5:51:48 GMT -5
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 06, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101) and is planning discussions with the U.S. Food and Drug Administration (FDA) regarding results and the ongoing clinical program. Clofazimine is being developed as an inhalation treatment option for nontuberculous mycobacterial (NTM) lung disease. NTM lung disease is a serious infection that is caused by bacteria common in the environment that can lead to a reduction in lung function, cough, fatigue, and quality of life. It is estimated that approximately 86,000 people in the U.S. are living with NTM lung disease, and it is on the rise growing 8% each year with women, the elderly, and those with underlying lung conditions at greatest risk. MNKD-101 has been designated by the FDA as both an orphan lung and a qualified infectious disease product (QIDP) for the treatment of pulmonary NTM infections. “There is a high unmet need to develop medicines that are well tolerated and effective in alleviating symptoms for those living with NTM lung disease,” said Michael Castagna, PharmD, Chief Executive Office of MannKind Corporation. “As we continue to expand our orphan lung diseases focus at MannKind, we are encouraged by what we are seeing with inhaled clofazimine and the future potential to help patients.” Study MKC-CI -001 was a Phase I randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-101 in healthy volunteers. 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 over a seven-day period No lab abnormalities, QT prolongation, or serious adverse events identified “The safety and tolerability results for inhaled clofazimine are encouraging and we look forward to advancing the nebulized formulation of clofazimine to the next phase of development,” said Thomas Hofmann, Chief Scientific Officer of MannKind Corporation. “Clofazimine presented as being very lipophilic and demonstrated the expected therapeutic plasma concentrations we were targeting. In future studies, we plan to evaluate the potential for MNKD-101 to produce drug levels that exceed the minimum inhibitory concentration in the lung beyond the treatment period.” 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. Additional data collected during the MKC-CI-001 study is currently undergoing final analysis. Detailed data findings will be presented in upcoming publications and scientific conferences. So MNKD is entering the nebulizer market. Do we know if MNKD is manufacturing the product or are they outsourcing? Was hoping it was a DPI but I believe Mike said a few Qtrs ago it wasn't and hoping it would convert into a DPI. MNKD signed UTHR partnership 90 days after Phase 1 approval of TreT (Tyvaso DPI). Will it happen this time?? Does anyone know the market size of Clofazamine - (see bold above)? Is this the drug Boehringer Ingelheim owns?? |
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Post by Thundersnow on Sept 6, 2022 5:56:41 GMT -5
I meant the Dollar Size of the market??
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Post by mango on Sept 6, 2022 7:17:41 GMT -5
It’s very encouraging when we successfully advance another pipeline candidate through the Phases. If successfully FDA approved, we will have years of exclusivity. It is my understanding this is a difficult agent to couple with FDKP and Mike has mentioned before they are fine with going nebulizer route, but will continue to explore developing a dry powder version for feasibility. I’m not sure if those efforts are still active or not. I suspect we will learn more as time unfolds.
What’s on my mind now is who will we partner with for this product? I imagine we will see an announcement sooner rather than later.
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Post by akemp3000 on Sept 6, 2022 7:21:43 GMT -5
Good that it's recognized by the FDA as an "orphan lung and qualified infectious disease". The term “orphan diseases” is used for ‘neglected’ conditions, i.e. where research on diagnosis and treatment is sparse, resulting in a lack of effective treatments. It's my understanding this designation allows for a faster and more economical path to approval. If others know differently, comments would be appreciated.
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Post by Thundersnow on Sept 6, 2022 7:39:40 GMT -5
Good that it's recognized by the FDA as an "orphan lung and qualified infectious disease". The term “orphan diseases” is used for ‘neglected’ conditions, i.e. where research on diagnosis and treatment is sparse, resulting in a lack of effective treatments. It's my understanding this designation allows for a faster and more economical path to approval. If others know differently, comments would be appreciated. That is true but we don't know the timeframe. I'm assuming it will be less than the 3-4 years for Tyvaso DPI. I'm hoping someone with deep pockets will sign up for NEB CLOF...... With 86K patients growing 8% a year and with a COVID-19 Indication maybe Novartis or Boehringer will step up to the plate and see the value with a partnership. |
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Post by anderson on Sept 6, 2022 7:44:30 GMT -5
Benifits orphan drug act 7 year exclusivity, tax credits of up to 25% for expenditures incurred during the clinical trials and can apply for waiver of PDUFA fees. QIDP +5 year exclusivity yep it is additive 12 years exclusivity in total
Sorry no voucher since it is not rare pediactric
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Post by Thundersnow on Sept 6, 2022 7:58:14 GMT -5
Could there be a bidding war for Clofazimine between UTHR and Novartis?
Would UTHR have the inside track since they have a 2nd molecule deal in place which means terms are already determined. Interesting....
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Post by anderson on Sept 6, 2022 8:10:48 GMT -5
Could there be a bidding war for Clofazimine between UTHR and Novartis? Would UTHR have the inside track since they have a 2nd molecule deal in place which means terms are already determined. Interesting.... I would hope MNKD has a bidding war for Clofazimine. No reason to give UTHR a sweetheart deal.
Now if you are saying for UTHR to green light the 2nd molecule(pretty sure it was tadalafil) and MNKD might give them a deal on Clofazimine so it is 2 molecule packages that might be interesting, since MNKD has reserved the right to sell tadalafil for ED and getting UTHR to foot the FDA approval bill would be nice. |
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Post by LongMNKD on Sept 6, 2022 8:58:47 GMT -5
If i were just watching the market, I'd say this was bad news. Down 3%. Doesn't make any sense
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Post by akemp3000 on Sept 6, 2022 9:59:50 GMT -5
As the football coach said to his wide receiver, "Don't take the head fake. Go long!"
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Post by RainbowUnicorn on Sept 6, 2022 10:24:17 GMT -5
If i were just watching the market, I'd say this was bad news. Down 3%. Doesn't make any sense The “MNKD Effect”.  |
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Post by novafett on Sept 6, 2022 10:54:29 GMT -5
I came here after seeing this headline on Fidelity (MannKind Shares Fall After Completing Initial Stage Lung Disease Study) and thinking "Great, more bad news". Gotta love lame title writers.. i didn't even bother reading the article, just came here for the truth.  |
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Post by dh4mizzou on Sept 6, 2022 11:02:29 GMT -5
I just hope we never get GREAT news :-O
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