- Clearance to proceed additionally obtained from well being authorities in South Korea and Australia, with Taiwan anticipated in 4Q 2024
- First U.S. affected person randomized
DANBURY, Conn., Sept. 18, 2024 (GLOBE NEWSWIRE) — MannKind Company MNKD, an organization targeted on the event and commercialization of revolutionary inhaled therapeutic merchandise and gadgets for sufferers with endocrine and orphan lung illnesses, introduced right this moment that it has obtained clearance from Japan’s Prescription drugs and Medical Units Company (PMDA) to provoke the Section 3 examine (ICoN-1) of Clofazimine Inhalation Suspension for the therapy of NTM lung illness. The worldwide examine is now cleared by well being authorities to proceed in 4 international locations (U.S., Japan, South Korea and Australia) with a fifth (Taiwan) anticipated in 4Q 2024.
“We’re happy to provoke the ICoN-1 examine in Japan in an effort to additional develop potential remedy for these dwelling with severe NTM lung infections,” mentioned Dr. Kozo Morimoto, lead principal investigator for ICoN-1 in Japan, Chief Physician for the Respiratory Illness Middle at Fukujuji Hospital and Japan Anti-Tuberculosis Affiliation. “Sufferers dwelling with NTM infections deserve secure, well-tolerated, handy, and efficient choices to deal with this severe respiratory illness that’s on the rise in Japan, in addition to globally.”
The ICoN-1 examine was initiated in the USA in June 2024 and had its first affected person randomized in September. In all, roughly 230 eligible contributors will likely be enrolled and randomized at greater than 100 websites throughout the U.S. and globally to make sure a minimal of 180 contributors are evaluable for efficacy. Particulars of the ICoN-1 examine and websites might be discovered at: ClinicalTrials.gov (NCT06418711).
In regards to the ICoN-1 Medical Trial
The continuing ICoN-1 trial is a multi-national, randomized, double-blind, placebo-controlled, Section 3 registrational examine to guage 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. The co-primary endpoints within the U.S. are sputum tradition conversion (unfavorable for NTM) from baseline to finish of Month 6 and alter in high quality of life (QoL) throughout the identical timeframe. Exterior the-U.S., the first endpoint is sputum tradition conversion.
In Could 2024, the U.S. Meals and Drug Administration (FDA) granted Quick Observe designation for Clofazimine Inhalation Suspension (MNKD-101) for the therapy of NTM lung illness. The FDA additionally beforehand designated Clofazimine Inhalation Suspension as each an orphan drug and a professional infectious illness product (QIDP) for the therapy of pulmonary NTM infections. A drug that receives orphan drug exclusivity receives seven years of exclusivity, and one which additionally earns QIDP designation, might obtain an extra 5 years of market exclusivity.
Clofazimine Inhalation Suspension was granted a patent (No. 11,793,808) by the USA Patent and Trademark Workplace protecting compositions of clofazimine and strategies for treating lung infections. The patent is just not attributable to expire till June 8, 2039. A corresponding clofazimine patent was granted in Japan (7377259), and patent functions are pending in different main markets.
About NTM – A World Well being Concern
Pulmonary NTM an infection is a uncommon illness with a world well being impression attributable to its rising prevalence worldwide and affiliation with shortened life span, excessive morbidity, and important impression on sufferers’ high quality of life. NTM is a gaggle of micro organism naturally present in our surroundings, together with water and soil, that may result in cough, fatigue, a discount in lung operate, and poor high quality of life amongst different debilitating signs. Whereas most individuals are uncovered to NTM every day, the organisms typically do no hurt. People with underlying circumstances comparable to COPD, bronchial asthma, and bronchiectasis are at elevated threat of NTM getting established within the lungs creating an an infection and progressive worsening of lung operate.
There are practically 200 species of NTM; the most typical is MAC, which accounts for about 80% of all NTM lung illness circumstances in the USA. Whereas not everyone seems to be prone to contracting NTM from MAC, for individuals who are, it could possibly trigger severe lung harm. NTM lung illness is extra frequent in girls over the age of 65. Estimated 2022 NTM illness prevalence is greater than 100,000 within the U.S. and over 150,000 in Japan. Roughly 15-20% of NTM sufferers are refractory. The prevalence fee of NTM is growing globally – throughout the U.S. alone claims-based research recommend an annual rise of seven.5%. To be taught extra about NTM, please go to LearnAboutNTM.com.
About MannKind
MannKind Company MNKD focuses on the event and commercialization of revolutionary inhaled therapeutic merchandise and gadgets to handle severe 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 comparable to diabetes, nontuberculous mycobacterial (NTM) lung illness, pulmonary fibrosis, and pulmonary hypertension. Our signature applied sciences – dry-powder formulations and inhalation gadgets – 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 group of Mannitarians collaborating nationwide, we’re on a mission to offer 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
This press launch accommodates forward-looking statements concerning the regulatory clearance to proceed with a medical examine that contain dangers and uncertainties. Phrases comparable to “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “purpose”, “potential” and comparable expressions are meant to determine 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 varied dangers and uncertainties, which embody, 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 studies on Type 10-Q and present studies on Type 8-Ok. 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 replicate occasions or circumstances after the date of this press launch.
MNKD-101 is an investigational product that’s not permitted for any use in any nation.
MANNKIND is a registered trademark of MannKind Company.
This press launch was printed by a CLEAR® Verified particular person.
MannKind Contacts: Christie Iacangelo Company Communications (818) 292-3500 [email protected] Investor Relations (818) 661-5000 [email protected]
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