MannKind Showcases Efficacy, Safety, and Mealtime Control Data from Recent Pediatric and Adult Studies of Afrezza® at the ATTD Conference, March 19-22
MannKind (MNKD) will present five studies on inhaled insulin at the 18th International Conference on Advanced Technologies and Treatments for Diabetes in Amsterdam, March 19-22, 2025. The presentations will showcase data from the INHALE-1 pediatric and INHALE-3 adult studies of Afrezza®.
Key presentations include research on pulmonary inhaled insulin, pediatric applications, sustained benefits from the INHALE-3 extension study, post-prandial glucose excursion comparisons between youth and adults with Type 1 diabetes, and a comparison study of inhaled Technosphere insulin plus insulin degludec versus usual care in adults.
The company anticipates filing a supplemental New Drug Application (sNDA) for Afrezza in the pediatric population in 2025. MannKind will also host booth #40 in the exhibit hall for scientific exchange with their Clinical Education Team.
MannKind (MNKD) presenterà cinque studi sull'insulina inalata alla 18ª Conferenza Internazionale sulle Tecnologie Avanzate e i Trattamenti per il Diabete che si terrà ad Amsterdam dal 19 al 22 marzo 2025. Le presentazioni mostreranno dati dagli studi pediatrici INHALE-1 e INHALE-3 per adulti di Afrezza®.
Le presentazioni chiave includeranno ricerche sull'insulina inalata per via polmonare, applicazioni pediatriche, benefici sostenuti dallo studio di estensione INHALE-3, confronti delle escursioni glicemiche post-prandiali tra giovani e adulti con diabete di tipo 1, e uno studio comparativo sull'insulina Technosphere inalata più insulina degludec rispetto alle cure abituali negli adulti.
L'azienda prevede di presentare una domanda supplementare per un nuovo farmaco (sNDA) per Afrezza nella popolazione pediatrica nel 2025. MannKind ospiterà anche lo stand n. 40 nel padiglione espositivo per uno scambio scientifico con il loro Team di Educazione Clinica.
MannKind (MNKD) presentará cinco estudios sobre insulina inhalada en la 18ª Conferencia Internacional sobre Tecnologías Avanzadas y Tratamientos para la Diabetes, que se llevará a cabo en Ámsterdam del 19 al 22 de marzo de 2025. Las presentaciones mostrarán datos de los estudios pediátricos INHALE-1 y INHALE-3 para adultos de Afrezza®.
Las presentaciones clave incluirán investigaciones sobre insulina inhalada por vía pulmonar, aplicaciones pediátricas, beneficios sostenidos del estudio de extensión INHALE-3, comparaciones de excursiones de glucosa postprandial entre jóvenes y adultos con diabetes tipo 1, y un estudio comparativo de insulina Technosphere inhalada más insulina degludec en comparación con el tratamiento habitual en adultos.
La empresa anticipa presentar una Solicitud de Nuevo Medicamento Suplementaria (sNDA) para Afrezza en la población pediátrica en 2025. MannKind también tendrá el stand #40 en el salón de exhibición para el intercambio científico con su Equipo de Educación Clínica.
MannKind (MNKD)는 2025년 3월 19일부터 22일까지 암스테르담에서 열리는 제18회 국제 고급 기술 및 당뇨병 치료 회의에서 흡입 인슐린에 대한 다섯 가지 연구를 발표할 예정입니다. 발표는 Afrezza®의 INHALE-1 소아 연구와 INHALE-3 성인 연구의 데이터를 보여줄 것입니다.
주요 발표 내용에는 폐 흡입 인슐린에 대한 연구, 소아 적용, INHALE-3 확장 연구에서의 지속적인 이점, 제1형 당뇨병을 가진 청소년과 성인 간의 식후 혈당 변화 비교, 성인에서 일반 치료와 비교한 흡입 Technosphere 인슐린과 인슐린 데글루덱에 대한 비교 연구가 포함됩니다.
회사는 2025년 소아 인구를 위한 Afrezza에 대한 보완 신약 신청(sNDA)을 제출할 것으로 예상하고 있습니다. MannKind는 또한 임상 교육 팀과의 과학적 교류를 위해 전시 홀에서 부스 #40을 운영할 예정입니다.
MannKind (MNKD) présentera cinq études sur l'insuline inhalée lors de la 18e Conférence Internationale sur les Technologies Avancées et les Traitements du Diabète qui se tiendra à Amsterdam du 19 au 22 mars 2025. Les présentations mettront en avant des données des études pédiatriques INHALE-1 et INHALE-3 pour adultes concernant Afrezza®.
Les présentations clés incluront des recherches sur l'insuline inhalée par voie pulmonaire, des applications pédiatriques, des bénéfices durables issus de l'étude d'extension INHALE-3, des comparaisons des excursions glycémiques postprandiales entre les jeunes et les adultes atteints de diabète de type 1, ainsi qu'une étude comparative de l'insuline Technosphere inhalée plus l'insuline degludec par rapport aux soins habituels chez les adultes.
L'entreprise prévoit de déposer une demande supplémentaire de nouveau médicament (sNDA) pour Afrezza dans la population pédiatrique en 2025. MannKind accueillera également le stand n° 40 dans le hall d'exposition pour un échange scientifique avec son équipe d'éducation clinique.
MannKind (MNKD) wird auf der 18. Internationalen Konferenz über Fortgeschrittene Technologien und Behandlungen für Diabetes, die vom 19. bis 22. März 2025 in Amsterdam stattfindet, fünf Studien zur inhalativen Insulintherapie präsentieren. Die Präsentationen werden Daten aus den INHALE-1 pädiatrischen und INHALE-3 Erwachsenenstudien zu Afrezza® zeigen.
Wichtige Präsentationen umfassen Forschungen zur pulmonalen inhalativen Insulintherapie, pädiatrische Anwendungen, nachhaltige Vorteile aus der INHALE-3 Erweiterungsstudie, Vergleiche der postprandialen Blutzuckeranstiege zwischen Jugendlichen und Erwachsenen mit Typ-1-Diabetes sowie eine Vergleichsstudie zur inhalativen Technosphere-Insulin plus Insulin Degludec im Vergleich zur üblichen Behandlung bei Erwachsenen.
Das Unternehmen plant, 2025 einen ergänzenden Antrag auf Zulassung eines neuen Arzneimittels (sNDA) für Afrezza in der pädiatrischen Bevölkerung einzureichen. MannKind wird auch Stand Nr. 40 in der Ausstellungshalle für den wissenschaftlichen Austausch mit ihrem Klinischen Bildungsteam haben.
- Planned sNDA filing for pediatric indication expansion in 2025
- Multiple positive study outcomes supporting Afrezza's efficacy across both pediatric and adult populations
- None.
Insights
MannKind's announcement about their upcoming ATTD Conference presentations carries significant implications for diabetes management, particularly for pediatric patients. The planned supplemental New Drug Application (sNDA) filing in 2025 for Afrezza in pediatric populations represents a critical expansion opportunity for inhaled insulin therapy.
The INHALE-1 pediatric study data being presented could potentially address a major unmet need in pediatric diabetes care. Injectable insulin administration presents notable challenges in children, including injection anxiety, compliance issues, and difficulty with timing relative to meals. An inhaled option could transform treatment adherence for this vulnerable population.
Equally noteworthy is the INHALE-3 extension study showing "sustained benefit" from inhaled insulin use. Long-term efficacy data is essential for chronic therapies, particularly for a medication with a novel delivery system. The presentation comparing inhaled Technosphere insulin plus insulin degludec versus usual care addresses the critical question of how Afrezza performs within existing treatment regimens.
Post-prandial glucose excursion comparison between youth and adults is particularly significant, as children often demonstrate greater glycemic variability than adults. Success in managing these challenging excursions would represent a meaningful clinical advance.
While the announcement suggests positive outcomes, without specific efficacy metrics or safety data, we should maintain measured expectations about the clinical significance pending full data presentation.
The anticipated sNDA filing for Afrezza in pediatric populations signifies that MannKind likely has robust safety and efficacy data from their INHALE-1 study. The regulatory pathway for expanding an existing approval to pediatric populations typically requires comprehensive evidence of both safety and similar pharmacokinetic/pharmacodynamic profiles to those seen in adults, with appropriate dose adjustments.
The FDA historically applies heightened scrutiny to respiratory-delivered medications in pediatric populations due to concerns about long-term pulmonary effects and differences in lung development. MannKind's confidence in pursuing this regulatory path suggests their data likely addresses these concerns adequately.
Pulmonary insulin delivery represents a unique regulatory challenge given insulin's narrow therapeutic window. The FDA will evaluate whether the dosing precision of inhaled delivery is comparable to injectable options in the pediatric setting, where dose requirements can change rapidly with growth and development.
If approved, this would represent the first inhaled insulin option for pediatric patients with diabetes – a significant market expansion beyond MannKind's current adult-only indication. The multiple presentations examining different aspects of Afrezza's performance (post-prandial control, comparison with standard care, sustained benefits) suggest a comprehensive data package supporting their regulatory strategy.
The 2025 timeline for submission is reasonable given the need to complete all analyses and prepare the extensive documentation required for an sNDA. Approval, if granted, would likely come 10-12 months after submission.
- Five presentations affirm positive outcomes utilizing inhaled insulin
- An sNDA filing for Afrezza in pediatric population anticipated in 2025
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.
“Data from both the INHALE-1 pediatric and INHALE-3 adult studies continue to drive groundbreaking conversations around inhaled insulin,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. "Afrezza continues to be an important treatment option for adults living with diabetes, including those utilizing MDI and AID, and we look forward to the study investigators’ presentations at the ATTD meeting.”
The following oral presentations are on the scientific program at ATTD 2025 to be held virtually and at the RAI Amsterdam Convention Center:
What’s New in Pulmonary Inhaled Insulin?
Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I
Presenter: Dr. Irl B. Hirsch
Inhaled Insulin in Pediatrics (INHALE-1 Peds Study)
Thursday, March 20, 2025 – 4:40 PM (CET) in Hall I
Presenter: Dr. Michael J. Haller
Sustained Benefit from Use of Inhaled Insulin in the INHALE-3 Extension Study
Saturday, March 22, 2025 – 11:05 AM (CET) at Station 4
Presenter: Dr. Grazia Aleppo
Post-Prandial Glucose Excursion with Inhaled Insulin in Youth Compared with Adults with Type 1 Diabetes (INHALE-1 Peds Study)
Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2
Presenter: Dr. Michael J. Haller
Comparison of a Regimen of Inhaled Technosphere Insulin Plus Insulin Degludec Versus Usual Care in Adults with Type 1 Diabetes
Saturday, March 22, 2025 – 11:30 AM (CET) in Hall D2
Presenter: Dr. Anastasios Manessis
In addition to the planned presentations, MannKind will host booth #40 in the exhibit hall (Hall I) throughout ATTD. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.
For more information about ATTD programming, and/or to register to attend the conference (virtual or in person), please visit: https://attd.kenes.com/register/.
About the INHALE-1 Pediatric Study
INHALE-1 is a Phase 3, randomized controlled trial in children and teenagers aged 4-17 with type 1 or type 2 diabetes to evaluate the efficacy and safety of inhaled insulin in combination with basal insulin versus multiple daily injections of rapid acting insulin in combination with basal insulin. The 26-week, open-label clinical trial randomized 230 pediatric subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing. Six-month results were announced by MannKind in December 2024, and 12-month findings are expected mid-year 2025.
About the INHALE-3 Study (Adults)
The INHALE-3 study was a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control.
The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The 17-week results shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks. The 30-week results from the study expanded upon the positive 17-week data and showed that more people living with T1D were able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care.
About Afrezza
Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus.
Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking.
Important Safety Information
| WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE |
|
Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled 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, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. 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, depending on the target indication.
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, X or Instagram.
Forward-Looking Statements
This press release contains forward-looking statements about planned presentations at a scientific conference and a potential sNDA submission for Afrezza that involves 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 issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining the expanded indication as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, 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.
AFREZZA and MANNKIND are registered trademarks of MannKind Corporation.
For MannKind: Media Relations Christie Iacangelo, (818) 292-3500 Email: media@mnkd.com Investor Relations Ana Kapor, (818) 661-5000 Email: ir@mnkd.com
FAQ
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Where and when is MannKind presenting their Afrezza data in 2025?
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