What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

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NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

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Release Details

MannKind Presents Two Posters At American Diabetes Association's Virtual 81st Scientific Sessions, June 25-29

06/25/21
PDF Version
- Poster 923-P: Phase 2 clinical study results revealed similar tolerability and time-action profile of Technosphere® Insulin in pediatric subjects as in published data for adults; provides rationale for conducting a Phase 3 study
- Poster 722-P: Data shared that Technosphere Insulin improved daytime time-in-range in people with type 2 diabetes

WESTLAKE VILLAGE, Calif., June 25, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD), which focuses on the development of innovative medicines for patients with endocrine and orphan lung diseases, will present two posters at the American Diabetes Association's virtual 81st Scientific Sessions, June 25-29.  The submissions include 923-P in Pediatrics-Type 1 Diabetes, and 722-P in Clinical Therapeutics/New Technology-Insulins.  MannKind is also hosting a booth in the virtual Exhibit Hall at the Scientific Sessions.

Poster 923-P
An insulin regimen that closely mimics physiologic insulin for pediatric patients with type 1 diabetes (T1D) remains a critical goal.  Poster 923-P reports on a Phase 2 clinical study to characterize the pharmacokinetics (PK) and safety of prandial Afrezza® (Technosphere® Insulin or TI) in 30 children aged 8 to 17 years with T1D.  Afrezza – an ultra rapid-acting dry-powder prandial insulin – is currently indicated to improve glycemic control in adults with T1D or type 2 (T2D) diabetes.

"The final results from the phase 2 pediatric study revealed that serum insulin concentrations peaked rapidly within 10-15 minutes of inhaled administration of TI, similar to the results observed previously in adults.  In addition, there were no severe hypoglycemic events or clinically relevant declines in pulmonary function, and no new or unexpected signals with TI," said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind and the presenting author of the study. "The pharmacokinetics and safety results provide us the rationale to move forward with conducting a phase 3 safety and efficacy study in pediatric patients with diabetes, which we expect to initiate in the fall."

PK measurements were obtained in 30 patients with T1D (median age of 12.7 years). Patients met criteria of using insulin for at least one year, and were on a stable regimen of basal-bolus insulin therapy for six weeks or greater. Insulin PK and blood glucose were assessed following single doses of TI.

Poster 722-P
Poster 722-P presents a retrospective analysis of data from the Levin study, an investigator-initiated trial sponsored by MannKind, to determine the effect of prandial inhaled insulin on daytime glucose levels in people with uncontrolled type 2 diabetes.  For purposes of the study, daytime was defined as 6:00 am to midnight.

  • Twenty T2D patients who had never been on mealtime insulin before were started on TI and rapidly titrated during the first week and followed for 12 weeks.
  • On average, patients showed an 83.5% increase in daytime time-in-range (70-180 mg/dL).
  • The study concluded that TI reduced patients' daytime time spent in hyperglycemia (>250 mg/dl) by 76.4% (p=0.0002) and without a significant increase in daytime time spent in hypoglycemia (<54 mg/dl) (p=0.0938).

"Daytime time-in-range continues to be the most challenging aspect of living with diabetes," said Dr. Philip Levin. "The data demonstrated that adding mealtime insulin helped decrease time spent in hyperglycemia and improved glycemic control for patients with T2D."

About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information about Afrezza, please visit afrezza.com.

About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more.

AFREZZA and TECHNOSPHERE are registered trademarks of MannKind Corporation.

 

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SOURCE MannKind Corporation

Christie Iacangelo, Corporate Communications, (818) 292-3500, media@mannkindcorp.com; Rose Alinaya, Investor Relations (818) 661-5000, ir@mannkindcorp.com