DANBURY, Conn. and WESTLAKE VILLAGE, Calif. - MannKind (NASDAQ:MNKD) Corporation (NASDAQ: MNKD) has announced the completion of patient enrollment for its INHALE-1 study, which evaluates the efficacy and safety of inhaled insulin in children and adolescents with diabetes. The clinical trial has successfully enrolled 305 patients living with type 1 or type 2 diabetes, marking a significant step forward in the development of treatment options for the pediatric population.
The INHALE-1 study is a 26-week, open-label, randomized clinical trial with an additional 26-week extension period. Its primary goal is to measure the change in HbA1c levels, a key indicator of blood sugar control, after 26 weeks. Secondary endpoints of the study include changes in fasting plasma glucose and the rate of hypoglycemic events. Participants in the trial, aged between 4 and 17 years, are being assessed on the use of Afrezza, an inhaled insulin product, in combination with basal insulin compared to the traditional multiple daily injections (MDI) approach.
Dr. Lori Laffel, Chief of the Pediatric, Adolescent, and Young Adult Section at Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School, underscored the importance of expanding treatment options for young people living with diabetes, as managing glucose levels at mealtimes continues to be a challenge.
MannKind expects to complete the primary endpoint analysis in the fourth quarter of 2024. If the trial results are positive, data dissemination and submission to the U.S. Food and Drug Administration (FDA) for potential approval are anticipated in 2025.
Dr. Kevin Kaiserman, Senior Vice President of Clinical Development and Medical Affairs at MannKind, expressed enthusiasm about reaching this milestone and the possibility of offering Afrezza as a treatment for a younger demographic affected by diabetes.
The company is known for its focus on the development and commercialization of inhaled therapeutic products aimed at addressing serious medical needs in endocrine and orphan lung diseases. MannKind's signature technologies include dry-powder formulations and inhalation devices designed for rapid and convenient delivery of medicines to the deep lung.
This announcement is based on a press release statement from MannKind Corporation.
InvestingPro Insights
As MannKind Corporation (NASDAQ: MNKD) advances its INHALE-1 study, investors and stakeholders are closely monitoring the company's financial health and market performance. According to real-time data from InvestingPro, MannKind boasts a market capitalization of $970.47 million USD, reflecting investor confidence in the company's potential despite its challenges.
InvestingPro Data highlights a significant revenue growth of 131.61% in the last twelve months as of Q3 2023, indicating a robust expansion in sales which aligns with the analysts' anticipation of sales growth in the current year. This is particularly noteworthy as MannKind continues to invest in clinical trials and product development, such as the INHALE-1 study for pediatric diabetes treatment.
In terms of profitability, MannKind's P/E ratio stands at -30.30, with an adjusted figure slightly lower at -31.02 for the same period, suggesting that the company is not currently profitable. This aligns with one of the InvestingPro Tips, which points out that analysts do not anticipate the company will be profitable this year. However, the company's liquid assets surpassing short-term obligations is a positive sign of financial stability.
InvestingPro also provides additional insights, with 5 more tips available for MannKind on their platform. For readers interested in a deeper dive into MannKind's financial metrics and future outlook, they can explore these additional InvestingPro Tips by visiting InvestingPro's MNKD page. Those looking to subscribe for a more comprehensive analysis can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
As MannKind gears up for the completion of its INHALE-1 study, these financial metrics and insights from InvestingPro could be crucial for investors seeking to understand the company's potential in the evolving diabetes treatment market.
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