Mannkind Successfully Completes Phase 1 Study of Inhaled Clofazimine
September 06 2022 - 6:15AM
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.
About MannKindMannKind Corporation (Nasdaq:
MNKD) focuses on the development and commercialization of
innovative therapeutic products and devices to address serious
unmet medical needs for those living with endocrine and orphan lung
diseases.
We are committed to using our formulation capabilities and
device engineering prowess to lessen the burden of diseases such as
diabetes, pulmonary arterial hypertension (PAH) and nontuberculous
mycobacterial (NTM) lung disease. Our signature technologies –
dry-powder formulations and inhalation devices – offer rapid and
convenient delivery of medicines to the deep lung where they can
exert an effect locally or enter the systemic circulation.
With a passionate team of Mannitarians collaborating nationwide,
we are on a mission to give people control of their health and the
freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on
LinkedIn, Facebook, Twitter or Instagram.
Forward-looking StatementsThis press release
contains forward-looking statements about the implications of
clinical data that involve risks and uncertainties. Words such as
“believes”, “anticipates”, “plans”, “expects”, “intends”, “will”,
“goal”, “potential” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon MannKind’s current expectations. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
the risk that continued testing of an investigational drug product
may not yield successful results or results that are consistent
with earlier testing, and other risks detailed in MannKind’s
filings with the Securities and Exchange Commission, including its
Annual Report on Form 10-K for the year ended December 31, 2021 and
subsequent periodic reports on Form 10-Q and current reports on
Form 8-K. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release. All forward-looking statements are qualified in
their entirety by this cautionary statement, and MannKind
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date of
this press release.
MANNKIND and the MannKind logo are registered trademarks of
MannKind Corporation.
For MannKind: Christie Iacangelo, Corporate Communications (818)
292-3500 Email: media@mannkindcorp.com
Rose Alinaya, Investor Relations(818) 661-5000Email:
ir@mannkindcorp.com
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