MannKind Presents Poster at 15th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2022) to Be Held April 27-30

Rhea-AI Summary

MannKind Corporation (Nasdaq: MNKD) announced a significant breakthrough in diabetes management at the ATTD 2022 conference. A proof-of-concept study revealed that a simplified 2x dose of Technosphere^® Insulin (TI) resulted in a mean difference of 52 mg/dL in post-prandial glucose excursions (PPGE) at 120 minutes compared to the standard dosage, showing enhanced efficacy without new safety concerns. This approach may improve glycemic control for diabetes patients and could influence future dosing recommendations.

Positive

• Statistically significant reduction in PPGE by 52 mg/dL with the 2x TI dose at 120 minutes.
• No new safety concerns reported, indicating high tolerability of the higher dose.
• Potential for improving glycemic control for diabetes patients through optimized dosing.

Negative

• None.

• Simplified 2x dose of Technosphere^® Insulin (TI) produced a statistically significant improvement in PPGE between Dose 1 & 2 from 45-120 minutes
• Higher dose of TI resulted in a mean difference of 52 mg/dL in PPGE at 120 minutes, with no new safety concerns

WESTLAKE VILLAGE, Calif., April 27, 2022 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has presented a poster [Abstract #445] at the 15^th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2022) held April 27-30 in Barcelona and virtually. The poster is now available to meeting attendees online.

The proof-of-concept study demonstrated that a simplified 2x dose of Technosphere^® Insulin (TI) provided significant reductions in post-prandial glucose excursions (PPGE) versus the current label dosage guidelines, with no new safety concerns. PPGE was tracked from 0 to 120 minutes following a standardized meal that was preceded by a dose of TI calculated in one of two ways: either based on the guidelines set forth in the current Afrezza^® packaging (Dose 1) or by doubling the subject’s injectable insulin dose and rounding down to the nearest available TI dose (Dose 2). A statistically significant improvement in PPGE was observed between Dose 1 and Dose 2 from 45-120 minutes, and the higher dose of TI resulted in a mean difference of 52 mg/dL at 120 minutes.

“We continue to explore new ways to help patients living with diabetes achieve better glycemic control and address potential underdosing with this therapy,” said Dr. Kevin Kaiserman, Vice President, Medical Affairs & Safety, Endocrine Business Unit for MannKind. “The DOS study provides valuable insights to inform our titration approach as we look at our current studies, including the INHALE-1 study of Afrezza in the pediatric population.”

“The perceived effect of the first dose of a medication greatly impacts the likelihood of a person taking a second dose of that medication,” said Dr. Timothy S. Bailey, MD, FACE, CPI, CEO & Founder of AMCR Institute. “This study demonstrated that using twice the previously recommended starting dose was more effective at managing post-prandial glucose excursions with no new safety concerns. Recommending this optimized dosing to people with diabetes has the potential to improve their post-prandial glucose control and persistence with this medication.”

Twenty adult participants (≥ 18 years) with type 1 diabetes (T1D) or type 2 diabetes (T2D) who were on subcutaneous basal-bolus insulin therapy were enrolled in the DOS study. On the first study visit, each subject received a standard meal that was preceded by Dose 1 of TI. At the next visit (2-3 days later), each subject received an identical meal that was preceded by Dose 2 of TI. Capillary blood glucose (SMBG) was measured immediately prior to the dose of TI and then afterward at 15, 30, 45, 60, 90 and 120 minutes.

The poster was authored by Timothy S. Bailey, MD; Mark Christiansen, MD; Sunil Bhavsar; Johanna Ulloa; Brandi Santogatta; Joseph Hanna; and Kevin Kaiserman, MD – representing a collaboration between the AMCR Institute (Escondido, Calif.), Diablo Clinical Research (Walnut Creek, Calif.), and MannKind.
  
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 located in Danbury, Conn., and Westlake Village, Calif. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more.

Forward-looking Statements
This press release contains forward-looking statements about future clinical studies and the implications of clinical data 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 Afrezza may not yield successful results or results that are consistent with earlier testing, and 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.

TECHNOSPHERE and AFREZZA are registered trademarks of MannKind Corporation.

FAQ

What does the recent study on Technosphere Insulin (MNKD) indicate about its effectiveness?

The study shows that a simplified 2x dose of Technosphere Insulin (TI) significantly improves post-prandial glucose excursions by a mean difference of 52 mg/dL at 120 minutes compared to standard dosing.

Were there any safety concerns reported in MannKind's Technosphere Insulin study?

No new safety concerns were reported during the study, suggesting the higher dose is well-tolerated by participants.

What conference did MannKind present its findings on Technosphere Insulin?

MannKind presented its findings at the 15th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2022) held from April 27-30, 2022.

How many participants were involved in the MannKind study on Technosphere Insulin?

The study involved 20 adult participants with type 1 or type 2 diabetes.