- First-in-human research to guage security, tolerability and pharmacokinetics (PK) in wholesome volunteers
- Enrollment of first research participant anticipated in June 2024
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 30, 2024 (GLOBE NEWSWIRE) — MannKind Company MNKD, an organization targeted on the event and commercialization of modern inhaled therapeutic merchandise and gadgets for sufferers with endocrine and orphan lung illnesses, introduced as we speak that it’ll proceed with a first-in-human Section 1 research of nintedanib DPI (MNKD-201) for pulmonary fibrotic illnesses, together with idiopathic pulmonary fibrosis (IPF).
“We’re happy to progress nintedanib DPI which comes on the heels of furthering our Section 3 research of Clofazimine Inhalation Suspension for nontuberculous mycobacterial (NTM) lung illnesses,” mentioned Michael Castagna, PharmD, Chief Government Officer of MannKind Company. “This places two research in movement by mid-year that can discover potential therapy choices for sufferers dwelling with critical lung illnesses.”
The Section 1 randomized, double-blind, placebo-controlled, single- (SAD) and multiple-ascending dose (MAD) research will consider the protection, tolerability, and pharmacokinetics (PK) of nintedanib inhalation powder (MNKD-201) in wholesome volunteers.
“Pulmonary fibrotic illnesses – specifically IPF – are power, progressive illnesses that end in lack of lung operate and, for a lot too many, shortened lifespans,” mentioned Dr. Wassim Fares, MSc, FCCP, Senior Vice President, Therapeutic Space Head, Orphan Lung Ailments of MannKind Company. “The group is keen and excited to provoke this research of MNKD-201 with outcomes anticipated later this 12 months, which can inform the following research of nintedanib DPI in sufferers with pulmonary fibrotic illnesses.”
The Pulmonary Fibrosis Basis signifies that there are over 250,000 People dwelling with pulmonary fibrosis (PF) as we speak, and 50,000 new circumstances are recognized every year. Whereas it’s unknown the variety of folks affected by IPF – the commonest type of pulmonary fibrosis – the most recent estimates point out that 1 in 200 adults over the age of 70 are impacted in the US. IPF is predominantly recognized in males, however additionally it is rising in girls.
About MannKind
MannKind Company MNKD focuses on the event and commercialization of modern inhaled therapeutic merchandise and gadgets to deal with critical unmet medical wants for these dwelling with endocrine and orphan lung illnesses.
We’re dedicated to utilizing our formulation capabilities and machine engineering prowess to minimize the burden of illnesses resembling diabetes, nontuberculous mycobacterial (NTM) lung illness, pulmonary fibrosis, and pulmonary hypertension. Our signature applied sciences – dry-powder formulations and inhalation gadgets – supply speedy and handy supply of medicines to the deep lung the place they’ll exert an impact domestically or enter the systemic circulation, relying on the goal indication.
With a passionate group of Mannitarians collaborating nationwide, we’re on a mission to present folks management of their well being and the liberty to reside life.
Please go to mannkindcorp.com to be taught extra, and observe us on LinkedIn, Facebook, X or Instagram.
Ahead-Wanting Statements
Statements on this press launch that aren’t statements of historic truth are forward-looking statements that contain dangers and uncertainties. These statements embrace, with out limitation, statements relating to the graduation of medical research of MNKD-201 and Clofazimine Inhalation Answer in addition to the timing of the information read-out from a Section 1 medical research of MNKD-201. Phrases resembling “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “purpose”, “potential” and related expressions are meant to establish forward-looking statements. These forward-looking statements are primarily based upon MannKind’s present expectations. Precise outcomes and the timing of occasions may differ materially from these anticipated in such forward-looking statements on account of numerous dangers and uncertainties, which embrace, with out limitation, the danger that continued testing of an investigational drug product might not yield profitable outcomes or outcomes which can be per earlier testing, and different dangers detailed in MannKind’s filings with the Securities and Change Fee, together with its Annual Report on Type 10-Okay for the 12 months ended December 31, 2023 and subsequent periodic reviews on Type 10-Q and present reviews on Type 8-Okay. You might be cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date of this press launch. All forward-looking statements are certified of their entirety by this cautionary assertion, and MannKind undertakes no obligation to revise or replace any forward-looking statements to mirror occasions or circumstances after the date of this press launch.
MNKD-201 is an investigational product that isn’t permitted for any use in any nation.
MANNKIND is a registered trademark of MannKind Company.
For MannKind: Christie Iacangelo, Company Communications (818) 292-3500 Electronic mail: [email protected] Rose Alinaya, Investor Relations (818) 661-5000 Electronic mail: [email protected]
