MannKind’s Inhaled Clofazimine Will Advance to an Adaptive Phase 2/3 Study For Potential Treatment of Rare Lung Disease
January 23 2023 - 5:05AM
MannKind Corporation (Nasdaq: MNKD), a company
focused on the development and commercialization of inhaled
therapeutic products and devices for patients with endocrine and
orphan lung diseases, today announced clofazimine inhalation
suspension (MNKD 101) will advance to an adaptive Phase 2/3 study.
Additionally, a paper has been published in the American Society
for Microbiology journal Antimicrobial Agents and Chemotherapy
examining the potential for treatment of nontuberculous
mycobacterial (NTM) infection through direct delivery of inhaled
clofazimine to the lungs, overcoming the systemic toxicity
witnessed in oral treatments.
Pulmonary NTM infection is recognized as a major global health
concern due to its rising prevalence worldwide. It 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 86,000-180,000
people in the U.S. alone 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.
“NTM lung disease typically translates to prolonged oral drug
treatments used off label that often result in high systemic
toxicity and serious side effects,” said Michael Castagna, PharmD,
Chief Executive Office of MannKind Corporation. “We are encouraged
by the preclinical and Phase 1 data, and how inhaled clofazimine
may finally resolve these issues, and most importantly, provide
patients with a potentially improved NTM therapy.”
The 28-day preclinical toxicology study included toxicokinetic
analyses on days 29, 56, and 84. The findings indicated:
- Significant residual drug in lung tissue, and long lung
residence post-dosing at all three dose levels
- Drug concentrations in the lung remained well above the average
NTM minimum inhibitory concentration (MIC, for MAC and Mabsc) at
all time points, with measurable clofazimine levels at 28- and
56-days post-dosing
“We are pleased to observe that in the preclinical model, our
drug concentration in the lung remained well above the average NTM
MIC when dosed for 28 days followed by a 56-day drug holiday,” said
Thomas Hofmann, MD, PhD, Chief Scientific Officer of MannKind
Corporation. “The demonstrated tolerability and lung loading
capability of inhaled clofazimine has been impressive and confirmed
in the Phase 1. We are now looking forward to studying this
investigational formulation for efficacy and safety in an NTM
patient population.”
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. 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
- No lab abnormalities, QT prolongation, or serious adverse
events were identified
A paper on clofazimine inhalation suspension is now available
online in the American Society for Microbiology journal
Antimicrobial Agents and Chemotherapy.
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 is a registered trademark of MannKind Corporation.
For MannKind:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: media@mannkindcorp.com
Rose Alinaya, Investor Relations
(818) 661-5000
Email: ir@mannkindcorp.com
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