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 to Give Oral Presentation on Meal Challenge Results From the Afrezza® With Basal Combination (ABC Study) at 16th Annual ATTD Conference

02/22/23
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  • Inhaled Technosphere® Insulin (TI) lowered peak glucose levels 30 minutes faster than injectable rapid-acting insulin delivered through an AID insulin pump and significantly lowered post-prandial glucose (PPG) from 45-120 minutes after a controlled meal challenge test
  • MannKind is planning a larger switch study in type 1 diabetes (T1D) to evaluate inhaled insulin with once-daily basal insulin in patients that switch from rapid-acting insulin given through multiple daily injections or any insulin pump delivery system

WESTLAKE VILLAGE, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it will present an oral presentation describing meal challenge results at the 16th International Conference on Advanced Technologies & Treatment for Diabetes (ATTD) in Berlin February 22-25.

Dr. Kevin Kaiserman, Vice President, Medical Affairs, Endocrine Business Unit for MannKind, will report meal challenge results from the Afrezza with Basal Combination proof-of-concept study during an oral presentation delivered on Feb 25.

The data showed that subjects utilizing inhaled Technosphere Insulin lowered peak glucose levels 30 minutes faster (200 mg/dl at 60 minutes) than subjects utilizing a rapid-acting analogue (RAA) with an Automated Insulin Delivery (AID) system (264 mg/dl at 90 minutes). Subjects utilizing TI also experienced a significantly lower mean PPG from 45 to 120 minutes post-meal.

“We believe inhaled insulin is an important option for those living with type 1 diabetes to reduce their PPG in the first 120 minutes,” said Dr. Kaiserman. “The study revealed a faster and lower peak in glucose that may assist patients in achieving improved glycemic control.”

“We are steadfast in our commitment to addressing the serious unmet need to improve mealtime control for those living with diabetes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “Based on the data collected from this pilot study we intend to move forward with a larger study this year to evaluate how we can reduce the diabetes burden as well as improve a patient’s ability to control their sugars in the first 120 minutes after they eat.”

Twenty-six adults with type 1 diabetes using AID systems completed the pilot study. The inhaled TI group (21 participants) utilized an inhaled insulin dose to cover a standardized meal whereas the AID control group (five participants) used AID-administered RAA to cover the standardized meal. Each participant consumed 37g of a nutritional shake (1 can of Boost®). Glucose was measured by self-monitored blood glucose (SMBG) at 15–30-minute intervals over two hours. The inhaled TI dosing used in this trial simplified the conversion from RAA that is contained in the current prescribing information. This dosing regimen was reported in a recently published study showing this new dose conversion provides better PPG control and does not give rise to any new safety concerns such as severe hypoglycemia.

Additional analysis from the ABC trial is expected to be presented at future conferences.

About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative 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, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. 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.

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, Twitter or Instagram.

Forward-Looking Statements
This press release contains forward-looking statements about the implications of clinical data and plans for future study that involve 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 continued testing of an investigational drug product may not yield successful results or results that are consistent with earlier testing, as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2021 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, TECHNOSPHERE and MANNKIND are registered trademarks of MannKind Corporation.


For MannKind:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: media@mannkindcorp.com

Rose Alinaya, Investor Relations
(818) 661-5000
Email: ir@mannkindcorp.com

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Source: MannKind