DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 29, 2024 (GLOBE NEWSWIRE) — MannKind Company MNKD, an organization centered on the event and commercialization of progressive inhaled therapeutic merchandise and units for sufferers with endocrine and orphan lung illnesses, introduced in the present day that the U.S. Meals and Drug Administration (FDA) has cleared the corporate’s Investigational New Drug (IND) utility for MNKD-101 (Clofazimine Inhalation Suspension), enabling the initiation of a Part 3 research for the remedy of nontuberculous mycobacterial (NTM) lung illness.
“Oral clofazimine has been utilized as a remedy choice for sufferers residing with NTM lung illness and we consider that by decreasing the dose and administering it on to the lung we are able to reveal improved dosing, tolerability and security,” mentioned Michael Castagna, PharmD, Chief Govt Officer of MannKind Company. “Advancing this program to a Part 3 trial, we’re inspired that MNKD-101 may probably deal with a severe unmet want that’s on the rise globally – significantly within the U.S. and the Asia Pacific area.”
This single registrational research, recognized as ICoN-1, anticipates getting underway by finish of 2Q 2024 within the U.S., and internationally within the second half of 2024. ICoN-1 is a multi-national, randomized, double-blind, placebo-controlled trial to judge the efficacy and security of Clofazimine Inhalation Suspension when added to guideline-based remedy in adults with refractory NTM lung illness attributable to Mycobacterium Avium Advanced (MAC), adopted by an open-label extension.
“Present regimens for sufferers residing with NTM lung illness require the usage of a number of drugs which are usually related to important antagonistic reactions and security considerations, extended durations of administration, and suboptimal outcomes each short-term and long-term,” mentioned Dr. Burkhard Clean, Govt Vice President, Analysis & Improvement and Chief Medical Officer of MannKind Company. “Sufferers residing with NTM deserve secure, well-tolerated, handy, and efficient choices to deal with this severe respiratory illness.”
Pulmonary NTM an infection is acknowledged as a significant international well being concern as a consequence of its rising prevalence worldwide, affiliation with shortened life span and important impression on sufferers’ every day residing. NTM is a bunch of micro organism naturally present in the environment, together with water and soil, that may result in cough, fatigue, a discount in lung operate, and poor high quality of life. Whereas most individuals are uncovered to NTM every day, the organisms usually do no hurt. People with underlying situations resembling COPD, bronchial asthma, and bronchiectasis are liable to NTM getting established within the lungs creating an an infection and progressive worsening of lung operate.
NTM lung illness is extra widespread in girls over the age of 65, with a predominance in these of Caucasian and Asian descent. In 2022, there have been roughly 122,000 and 159,000 sufferers residing with NTM within the U.S. and Japan, respectively, with as a lot as 20% of these circumstances being refractory. The illness state is on the rise, with an estimated annual progress charge averaging 8%.
About MannKind
MannKind Company MNKD focuses on the event and commercialization of progressive inhaled therapeutic merchandise and units to deal with severe unmet medical wants for these residing 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 units – provide fast 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 staff of Mannitarians collaborating nationwide, we’re on a mission to present individuals management of their well being and the liberty to dwell life.
Please go to mannkindcorp.com to be taught extra, and observe us on LinkedIn, Facebook, X or Instagram.
Ahead-Wanting Statements
This press launch comprises forward-looking statements concerning the initiation of a medical research and the potential attributes of an investigational product to deal with an unmet medical want that contain dangers and uncertainties. Phrases resembling “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “aim”, “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 because of varied dangers and uncertainties, which embrace, with out limitation, the danger that continued testing of an investigational drug product could not yield profitable outcomes or outcomes which are according to 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 yr ended December 31, 2023 and subsequent periodic studies on Type 10-Q and present studies 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-101 is an investigational product that isn’t accepted for any use in any nation.
MANNKIND is a registered trademark of MannKind Company.
For MannKind: Christie Iacangelo, Company Communications (818) 292-3500 E mail: [email protected] Rose Alinaya, Investor Relations (818) 661-5000 E mail: [email protected]
