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Post by sla55 on Mar 4, 2024 13:05:48 GMT -5
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-corporation-announces-participation-upcoming-0?_gl=1*1nvmyqx*_ga*NzE2OTk0OTAyLjE3MDk1NzU0NDk.*_ga_4PG70PBDQW*MTcwOTU3NTQ0OC4xLjEuMTcwOTU3NTQ1NS41My4wLjA. MannKind Corporation Announces Participation at Upcoming Conferences 03/04/24 WESTLAKE VILLAGE, Calif. and DANBURY, Conn., March 04, 2024 (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 be participating at upcoming conferences. Leerink Partners Global Biopharma Conference 2024 – Investor Meetings, Monday, March 11, 2024 Oppenheimer 34th Annual Healthcare MedTech & Services Conference – Corporate Presentation, Wednesday, March 13, 2024 at 9:20 am (ET) and Investor Meetings Interested parties can access a link to the live webcast of the presentation from the Events & Presentations section of the Company’s website at investors.mannkindcorp.com/events-and-presentations. The webcast replay may be accessed at the same location for 14 days following the live presentation.
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Post by neil36 on Mar 5, 2024 6:11:00 GMT -5
MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8
03/05/24
PDF Version
Dr. Hirsch to present meal challenge results when switching from multiple daily injections (MDI) or insulin pumps to inhaled insulin (Afrezza® (insulin human) Inhalation Powder)
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 05, 2024 (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 new clinical data from the INHALE-3 study first meal challenge will be presented at the upcoming 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 6-9. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
Dr. Irl B. Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington and the INHALE-3 Study Protocol Chair, will provide an oral presentation focused on findings from a standardized meal challenge, including:
Post-prandial glucose with inhaled insulin vs. subcutaneous rapid-acting analogue (RAA)
Glucose outcomes including AUC and time to peak during the first two hours and beyond
Frequency of post-meal hypoglycemia in both groups
“We are looking forward to the first slice of INHALE-3 data being presented here that builds upon findings from our pilot ABC study shared at last year’s ATTD Conference,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “With ABC and this trial, we used a higher initial conversion dose for inhaled insulin than in our current label. In the ABC study, this conversion dose produced significantly lowered post-prandial glucose levels that peaked 30 minutes sooner than standard of care. At ATTD, we are presenting INHALE-3’s meal challenge with a much larger comparator group across treatment regimens.”
Dr. Hirsch will deliver his oral presentation at 11:15 a.m. EST (5:15 p.m. CET) on Friday, March 8, 2024. Further data will be provided post-conference.
INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study randomly assigned participants over 18 years of age with T1D who are using MDI, an AID system, or a pump without automation to either continue their standard of care or adopt an insulin regimen of a daily basal injection plus Afrezza at mealtimes. Both arms utilized continuous glucose monitoring to assess mealtime control and A1c levels. More information on the study is available at: ClinicalTrials.gov(NCT05904743).
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 planned release of results from an ongoing clinical study 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 we may not achieve our projected development goals in the timeframes we expect, 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, 2023, 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.
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Post by neil36 on Mar 5, 2024 6:13:55 GMT -5
Cantor Fitzgerald biotech/biopharma analysts analyst/industry conference call Biopharma Analysts Chen & Leung, Biotech Analysts Kim & Brayer, along with Dr. Ruoss, Professor of Medicine at Stanford University, discuss new and emerging treatments for Nontuberculous Mycobacteria (NTM) (relevant companies INSM, SPRO, ANTX, MNKD) on an Analyst/Industry conference call to be held on March 5 at 11 am. [Webcast Link] cantor.zoom.us/webinar/register/WN_k2pBx61tTcSj9BAfn-1qrg?_x_zm_rtaid&#/registration |
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Post by celo on Mar 5, 2024 9:31:29 GMT -5
ir.unither.com/press-releases/2024/02-27-2024-110011346SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Michael Benkowitz, President and Chief Operating Officer, will provide an overview and update on the company’s operations during a fireside chat session at the TD Cowen 44th Annual Health Care Conference in Boston. The session will take place on Tuesday, March 5, 2024, from 12:50 p.m. to 1:20 p.m., Eastern Standard Time, and can be accessed via a live webcast on the United Therapeutics website at ir.unither.com/events-and-presentations. An archived, recorded version of the session will be available approximately 24 hours after the session ends and can be accessed for 90 days.
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Post by mango on Mar 5, 2024 11:46:58 GMT -5
MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8 03/05/24 PDF Version Dr. Hirsch to present meal challenge results when switching from multiple daily injections (MDI) or insulin pumps to inhaled insulin (Afrezza® (insulin human) Inhalation Powder) DANBURY, Conn. and WESTLAKE VILLAGE, Calif., March 05, 2024 (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 new clinical data from the INHALE-3 study first meal challenge will be presented at the upcoming 17th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence on March 6-9. INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care. Dr. Irl B. Hirsch, Professor of Medicine and Diabetes Treatment and Teaching Chair at the University of Washington and the INHALE-3 Study Protocol Chair, will provide an oral presentation focused on findings from a standardized meal challenge, including: Post-prandial glucose with inhaled insulin vs. subcutaneous rapid-acting analogue (RAA) Glucose outcomes including AUC and time to peak during the first two hours and beyond Frequency of post-meal hypoglycemia in both groups “We are looking forward to the first slice of INHALE-3 data being presented here that builds upon findings from our pilot ABC study shared at last year’s ATTD Conference,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “With ABC and this trial, we used a higher initial conversion dose for inhaled insulin than in our current label. In the ABC study, this conversion dose produced significantly lowered post-prandial glucose levels that peaked 30 minutes sooner than standard of care. At ATTD, we are presenting INHALE-3’s meal challenge with a much larger comparator group across treatment regimens.” Dr. Hirsch will deliver his oral presentation at 11:15 a.m. EST (5:15 p.m. CET) on Friday, March 8, 2024. Further data will be provided post-conference. INHALE-3 is a 17-week randomized controlled trial with a 13-week extension. The study randomly assigned participants over 18 years of age with T1D who are using MDI, an AID system, or a pump without automation to either continue their standard of care or adopt an insulin regimen of a daily basal injection plus Afrezza at mealtimes. Both arms utilized continuous glucose monitoring to assess mealtime control and A1c levels. More information on the study is available at: ClinicalTrials.gov(NCT05904743). 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 planned release of results from an ongoing clinical study 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 we may not achieve our projected development goals in the timeframes we expect, 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, 2023, 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. Remember several years ago when I had those email exchanges with Hirsch regarding a publication that had an error in it that I wanted them to correct? It might have had something to do with insulin derived amyloidosis, I don't recall exactly but I made a thread about it. Anyways, I had emailed Mike the email exchanges and the next thing you know Mike is on a plane to meet with Hirsch over lunch and brings him on to the Scientific Advisory Board. Now, Hirsch is presenting Afrezza data at a large diabetes conference. Incredible! If that isn't a go getter I don't know what is! Having Hirsch present the data seems a bit of an anomoly in my opinion. I suspect these data that Hirsch is presenting will be ground breaking. |
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Post by agedhippie on Mar 5, 2024 11:58:26 GMT -5
... Having Hirsch present the data seems a bit of an anomaly in my opinion. I suspect these data that Hirsch is presenting will be ground breaking. You are absolutely right. Having Irl Hirsch presenting this gives it serious credibility. |
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Post by mango on Mar 5, 2024 12:17:37 GMT -5
... Having Hirsch present the data seems a bit of an anomaly in my opinion. I suspect these data that Hirsch is presenting will be ground breaking. You are absolutely right. Having Irl Hirsch presenting this gives it serious credibility. Holy smokes. Could it be that serious credibility is warranted for presenting serious, ground breaking results? Could this in fact be the results we have all been waiting for? This is a huge anomaly to have someone like Hirsch present this data. |
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Post by prcgorman2 on Mar 5, 2024 12:23:28 GMT -5
I've only heard of Dr. Irl Hirsch through MNKD ProBoards. To learn more about him, instead of a Google search, I asked ChatGPT. I liked the answer. It helped me understand the endorsement from agedhippie. ChatGPT Dr. Irl Hirsch is a prominent figure in the field of diabetes research and treatment. He is a board-certified endocrinologist and a Professor of Medicine at the University of Washington School of Medicine in Seattle, where he also serves as the Diabetes Treatment and Teaching Chair. Dr. Hirsch is known for his expertise in diabetes management, particularly in the areas of insulin therapy and diabetes technology. Dr. Hirsch has made significant contributions to diabetes research and clinical practice through his work in several key areas: Insulin Therapy: Dr. Hirsch has conducted extensive research on insulin therapy, including the development and evaluation of new insulin formulations and delivery methods. He has studied the pharmacokinetics and pharmacodynamics of different types of insulin and their effects on blood glucose control in individuals with diabetes. Diabetes Technology: Dr. Hirsch has been involved in the evaluation and implementation of diabetes technology, including continuous glucose monitoring (CGM) systems, insulin pumps, and closed-loop insulin delivery systems (artificial pancreas). He has conducted clinical trials to assess the safety, efficacy, and usability of these technologies in people with diabetes. Clinical Practice Guidelines: Dr. Hirsch has played a role in developing clinical practice guidelines for the management of diabetes. He has served on expert panels and advisory boards for professional organizations such as the American Diabetes Association (ADA) and the Endocrine Society, contributing to the development of evidence-based recommendations for diabetes care. Education and Advocacy: Dr. Hirsch is actively involved in medical education and advocacy efforts aimed at improving diabetes care. He lectures nationally and internationally on topics related to diabetes management and serves as a mentor to medical students, residents, and fellows interested in endocrinology. Overall, Dr. Irl Hirsch is recognized as a leader in the field of diabetes research and treatment, with a focus on advancing insulin therapy, diabetes technology, and clinical practice guidelines to improve outcomes for individuals living with diabetes. His contributions have had a significant impact on the understanding and management of diabetes worldwide. |
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Post by prcgorman2 on Mar 5, 2024 12:28:28 GMT -5
Maybe Dr. Hirsch will do for MannKind what Dr. Kendall couldn't. Nothing against Dr. Kendall. Could just be a matter of right person, right place, right time. We will see.
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Post by akemp3000 on Mar 5, 2024 14:40:08 GMT -5
And right words. Dr. Hirsch may have the opportunity to make a ground breaking announcement if he chooses to do so. IMO, depending on the results and the words he chooses, it has the potential to be a shot heard round the diabetes world. If so, this might be a big milestone in the long history of Afrezza.
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Post by mango on Mar 5, 2024 15:18:49 GMT -5
I have to suspect that something big, perhaps really big, is going to be presented this Friday. March 8 by Irl Hirsch. Hirsch is the “real mccoy.” Read his patient reviews online, he has impeccable patient satisfaction and is tremendous diabetes thought leader.
He is the former chair of the Professional Practice Committee for the American Diabetes Association, and a member of the American Board of Internal Medicine. He has authored over 170 papers, numerous book chapters and six books both for patients and physicians and is section editor for UptoDate. He received the American Diabetes Association’s Josiah K. Lilly Sr. Distinguished Service Award and was elected to a Mastership by the American College of Physicians.
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Post by agedhippie on Mar 5, 2024 15:52:04 GMT -5
Found it! That was hard work and mildly disappointing. This the same as last year, a 10 minute presentation on a standardized meal test covering the two hours post-prandial which Afrezza should hit out of the park. Basically nothing new and just a larger data set. However, since it's Irl Hirsch rather than the Vice President - Medical Affairs and Safety at Mannkind delivering the results I expect more people will pay attention this time (it avoids the appearance of being biased.)
The Results section says just for the first two hours (main outcomes include peak glucose during the first 2 hours), but the Methods section says 2-6 hours following ingestion of the meal, and hopefully the talk will include details on beyond the two hour mark as that is important.
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POSTPRANDIAL GLUCOSE FOLLOWING A BOLUS WITH INHALED INSULIN VERSUS USUAL CARE (ID 442)
Presenter
Irl B. Hirsch (United States of America)
Lecture Time
17:15 - 17:25
Abstract
Background and Aims
Technosphere Insulin is an ultra-rapid-acting inhaled insulin. This study evaluates the efficacy and safety during the postprandial period following a bolus with inhaled insulin compared to usual care. This study builds on the oral presentation delivered at ATTD 2023 in Berlin with a larger sample size and longer analysis window following the meal.
Methods
120-140 adults with type 1 diabetes and using continuous glucose monitoring (CGM) at 19 investigational sites were randomized 1:1 to continue their current insulin therapy (MDI or CSII with or without automation) or to the study group using inhaled insulin. All subjects ingested a standardized meal and glucose was monitored with blinded CGM for 2-6 hours following ingestion of the meal. The inhaled insulin group took their inhaled insulin dose immediately prior the meal while the usual care group took their rapid-acting insulin analogue 10 +/- 5 minutes before the meal.
Results
The main outcomes include peak glucose during the first 2 hours, time to peak glucose, AUC 180 mg/dL, and safety events. As of September 12, 2023, 30 participants have completed the standardized meal. The remaining participants will complete the randomized meal challenge by December 2023. Complete results will be presented.
Conclusions
Expected conclusion to include summary of results highlighting the efficacy and safety outcomes.
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Post by longliner on Mar 5, 2024 16:06:38 GMT -5
Found it! That was hard work and mildly disappointing. This the same as last year, a 10 minute presentation on a standardized meal test covering the two hours post-prandial which Afrezza should hit out of the park. Basically nothing new and just a larger data set. However, since it's Irl Hirsch rather than the Vice President - Medical Affairs and Safety at Mannkind delivering the results I expect more people will pay attention this time (it avoids the appearance of being biased.) The Results section says just for the first two hours ( main outcomes include peak glucose during the first 2 hours), but the Methods section says 2-6 hours following ingestion of the meal, and hopefully the talk will include details on beyond the two hour mark as that is important. ----- POSTPRANDIAL GLUCOSE FOLLOWING A BOLUS WITH INHALED INSULIN VERSUS USUAL CARE (ID 442) Presenter Irl B. Hirsch (United States of America) Lecture Time 17:15 - 17:25 Abstract Background and Aims Technosphere Insulin is an ultra-rapid-acting inhaled insulin. This study evaluates the efficacy and safety during the postprandial period following a bolus with inhaled insulin compared to usual care. This study builds on the oral presentation delivered at ATTD 2023 in Berlin with a larger sample size and longer analysis window following the meal. Methods 120-140 adults with type 1 diabetes and using continuous glucose monitoring (CGM) at 19 investigational sites were randomized 1:1 to continue their current insulin therapy (MDI or CSII with or without automation) or to the study group using inhaled insulin. All subjects ingested a standardized meal and glucose was monitored with blinded CGM for 2-6 hours following ingestion of the meal. The inhaled insulin group took their inhaled insulin dose immediately prior the meal while the usual care group took their rapid-acting insulin analogue 10 +/- 5 minutes before the meal. Results The main outcomes include peak glucose during the first 2 hours, time to peak glucose, AUC 180 mg/dL, and safety events. As of September 12, 2023, 30 participants have completed the standardized meal. The remaining participants will complete the randomized meal challenge by December 2023. Complete results will be presented. Conclusions Expected conclusion to include summary of results highlighting the efficacy and safety outcomes. Thanks for the hard work! It's only disappointing if you're on the sidelines! Or short.  |
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Post by mango on Mar 5, 2024 17:50:34 GMT -5
Found it! That was hard work and mildly disappointing. This the same as last year, a 10 minute presentation on a standardized meal test covering the two hours post-prandial which Afrezza should hit out of the park. Basically nothing new and just a larger data set. However, since it's Irl Hirsch rather than the Vice President - Medical Affairs and Safety at Mannkind delivering the results I expect more people will pay attention this time (it avoids the appearance of being biased.) The Results section says just for the first two hours ( main outcomes include peak glucose during the first 2 hours), but the Methods section says 2-6 hours following ingestion of the meal, and hopefully the talk will include details on beyond the two hour mark as that is important. ----- POSTPRANDIAL GLUCOSE FOLLOWING A BOLUS WITH INHALED INSULIN VERSUS USUAL CARE (ID 442) Presenter Irl B. Hirsch (United States of America) Lecture Time 17:15 - 17:25 Abstract Background and Aims Technosphere Insulin is an ultra-rapid-acting inhaled insulin. This study evaluates the efficacy and safety during the postprandial period following a bolus with inhaled insulin compared to usual care. This study builds on the oral presentation delivered at ATTD 2023 in Berlin with a larger sample size and longer analysis window following the meal. Methods 120-140 adults with type 1 diabetes and using continuous glucose monitoring (CGM) at 19 investigational sites were randomized 1:1 to continue their current insulin therapy (MDI or CSII with or without automation) or to the study group using inhaled insulin. All subjects ingested a standardized meal and glucose was monitored with blinded CGM for 2-6 hours following ingestion of the meal. The inhaled insulin group took their inhaled insulin dose immediately prior the meal while the usual care group took their rapid-acting insulin analogue 10 +/- 5 minutes before the meal. Results The main outcomes include peak glucose during the first 2 hours, time to peak glucose, AUC 180 mg/dL, and safety events. As of September 12, 2023, 30 participants have completed the standardized meal. The remaining participants will complete the randomized meal challenge by December 2023. Complete results will be presented. Conclusions Expected conclusion to include summary of results highlighting the efficacy and safety outcomes. Can you post the link to where you found this? |
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Post by mango on Mar 5, 2024 17:52:30 GMT -5
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