- Met major goal demonstrating nintedanib DPI was secure and nicely tolerated
- Members didn’t expertise adversarial occasions sometimes reported with oral nintedanib
- Anticipate to satisfy with the FDA in 1H 2025 to advance MNKD-201 into the following section of improvement
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 04, 2024 (GLOBE NEWSWIRE) — MannKind Company MNKD, an organization targeted on the event and commercialization of revolutionary inhaled therapeutic merchandise and units for sufferers with endocrine and orphan lung illnesses, right now introduced the profitable completion of its first-in-human Section 1 examine of nintedanib DPI (MNKD-201) for pulmonary fibrotic illnesses, together with idiopathic pulmonary fibrosis (IPF).
“These compelling outcomes assist advancing the event of nintedanib DPI for sufferers dwelling with IPF, a continual and progressive fibrotic lung illness with restricted remedy choices,” stated Michael Castagna, PharmD, Chief Govt Officer for MannKind Company. “We stay up for discussing the Section 1 trial outcomes and our proposed late-stage improvement program at an finish of section 1 assembly with the FDA, deliberate for the primary half of 2025.”
The important thing highlights of the examine included:
- Nintedanib DPI was proven to be secure and nicely tolerated in wholesome volunteers with the examined doses and examine length
- Members didn’t expertise typical adversarial occasions seen with oral nintedanib; particularly, no GI or neurologic adversarial occasions (AEs) had been reported
- Two kinds of AEs famous – cough and drop in FEV-1
- These AEs had been delicate, transient, and absolutely recovered
- These AEs weren’t dose-dependent and there was no sample of recurrence or worsening with repeated dosing
- No bronchospasm, wheezing, different signs, or change in important indicators had been reported
- No critical adversarial occasions or examine drug discontinuation
The finished Section 1 was a single-site, randomized, placebo-controlled, single- (n=24) and multiple-ascending dose (n=16) examine in wholesome grownup (older than 40 years outdated) members. The first goal of the examine was to guage the security and tolerability of nintedanib DPI. The secondary examine goal was to guage the pharmacokinetics (PK) of MNKD-201.
“We’re inspired by the findings from this Section 1 examine of nintedanib DPI,” stated Dr. Wassim Fares, MSc, FCCP, Senior Vice President, Therapeutic Space Head, Orphan Lung Illnesses for MannKind Company. “Constructing on the recognized efficacy of oral nintedanib for IPF, supply of a dry powder formulation on to the lungs might doubtlessly deal with the illness whereas decreasing the frequent adversarial results related to oral supply of nintedanib. Pending late-stage improvement trials, nintedanib DPI might supply an alternate and/or addition to present IPF therapies.”
Moreover, the preclinical continual toxicology examine didn’t present any adversarial findings and helps additional improvement of nintedanib DPI.
About Pulmonary Fibrosis and IPF
The Pulmonary Fibrosis Basis signifies that there are over 250,000 People dwelling with pulmonary fibrosis (PF) and interstitial lung illness (ILD) right now, and 50,000 new instances are identified annually. Whereas the variety of folks affected by IPF is unknown, it is likely one of the commonest types of pulmonary fibrosis. IPF is predominantly recognized in males however can also be growing in girls.
About MannKind
MannKind Company MNKD focuses on the event and commercialization of revolutionary inhaled therapeutic merchandise and units 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 similar to diabetes, nontuberculous mycobacterial (NTM) lung illness, pulmonary fibrosis, and pulmonary hypertension. Our signature applied sciences – dry-powder formulations and inhalation units – supply fast and handy supply of medicines to the deep lung the place they’ll exert an impact regionally or enter the systemic circulation, relying on the goal indication.
With a passionate crew 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 study extra, and observe us on LinkedIn, Facebook, X or Instagram.
Ahead-Trying 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 concerning the continued medical improvement of MNKD-201, deliberate interactions with the FDA in addition to the potential for a brand new remedy to deal with illness with fewer adversarial occasions. Phrases similar to “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “aim”, “potential” and comparable expressions are meant to determine forward-looking statements. These forward-looking statements are based mostly upon MannKind’s present expectations. Precise outcomes and the timing of occasions might differ materially from these anticipated in such forward-looking statements because 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 in line with earlier testing, and different dangers detailed in MannKind’s filings with the Securities and Alternate Fee, together with its Annual Report on Type 10-Ok for the 12 months ended December 31, 2023 and subsequent periodic stories on Type 10-Q and present stories on Type 8-Ok. You’re 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 replicate occasions or circumstances after the date of this press launch.
MNKD-201 is an investigational product that’s not authorised for any use in any nation.
MANNKIND is a registered trademark of MannKind Company.
For MannKind: Media Relations Christie Iacangelo (818) 292-3500 E-mail: [email protected] Investor Relations Ana Kapor (818) 661-5000 E-mail: [email protected]
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