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Post by kite on Jul 31, 2019 8:01:43 GMT -5
www.globenewswire.com/news-release/2019/07/31/1894774/0/en/Afrezza-Safety-and-Pharmacokinetics-Study-in-Pediatric-Patients-Opens-Enrollment-for-Cohort-3.htmlWESTLAKE VILLAGE, Calif., July 31, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced today that the Afrezza® safety and pharmacokinetics study in pediatric patients is now enrolling children 4-7 years of age (Cohort 3) and nearing completion for Cohort 2 (8-12 years of age). An interim review of data from individuals participating in the second cohort shows that the single‑dose pharmacokinetic profile of insulin levels for this age group is consistent with the pattern seen in adults. In addition, dosing over one month demonstrated a safety profile that was also consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the third cohort of subjects. This third and final cohort will study Afrezza in children aged 4-7 years and will assess insulin levels, glucose changes, and the short-term safety and tolerability of multiple doses of Afrezza. “We are very pleased that we can extend the study to younger children who could benefit from the flexible dosing Afrezza provides and thankful for the families and investigators who have participated to date,” said David Kendall, M.D., Chief Medical Officer of MannKind. For additional information about the study, please contact John Krueger, Vice President, Clinical Development, MannKind Corporation at jkrueger@mannkindcorp.com.
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Post by peppy on Jul 31, 2019 8:15:31 GMT -5
www.globenewswire.com/news-release/2019/07/31/1894774/0/en/Afrezza-Safety-and-Pharmacokinetics-Study-in-Pediatric-Patients-Opens-Enrollment-for-Cohort-3.htmlWESTLAKE VILLAGE, Calif., July 31, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) announced today that the Afrezza® safety and pharmacokinetics study in pediatric patients is now enrolling children 4-7 years of age (Cohort 3) and nearing completion for Cohort 2 (8-12 years of age). An interim review of data from individuals participating in the second cohort shows that the single‑dose pharmacokinetic profile of insulin levels for this age group is consistent with the pattern seen in adults. In addition, dosing over one month demonstrated a safety profile that was also consistent with that observed in adults. As a result of these findings, MannKind and the study investigators are proceeding with enrollment of the third cohort of subjects. This third and final cohort will study Afrezza in children aged 4-7 years and will assess insulin levels, glucose changes, and the short-term safety and tolerability of multiple doses of Afrezza. “We are very pleased that we can extend the study to younger children who could benefit from the flexible dosing Afrezza provides and thankful for the families and investigators who have participated to date,” said David Kendall, M.D., Chief Medical Officer of MannKind. For additional information about the study, please contact John Krueger, Vice President, Clinical Development, MannKind Corporation at jkrueger@mannkindcorp.com. my understanding is this is still phase one the safety levels. 3rd cohort of the phase one. Afrezza Safety and Pharmacokinetics Study in Pediatric Patients clinicaltrials.gov/ct2/show/NCT02527265 |
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Post by myocat on Jul 31, 2019 8:37:30 GMT -5
It's P2.
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Post by Clement on Jul 31, 2019 8:46:09 GMT -5
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Post by longliner on Jul 31, 2019 9:05:53 GMT -5
The announcement could have been "we will NOT continue with the 3rd cohort safety study with the 4-7 year old demographic".
Even if expected, this announcement is huge news IMHO!
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Post by seanismorris on Jul 31, 2019 9:26:14 GMT -5
MannKind needed a talking point for the investor call.
Watch the left hand, ignore the right hand... (right hand = Afrezza marketing)
It took MannKind (Mike) inexplicably years to get this far with the Pediatric Study. Better laaaate than never... I guess.
I was once excited about the study, but then I had year after year of disappoint.
Kids same as adults, is pretty much “tell me something I didn’t already know”. What I want to know is how they will spin this to increase sales...
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Post by myocat on Jul 31, 2019 9:29:30 GMT -5
The announcement could have been "we will NOT continue with the 3rd cohort safety study with the 4-7 year old demographic". Even if expected, this announcement is huge news IMHO! How about "P2 and P3 are terminated due to superior safety, tolerability and efficacy" ? |
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Post by awesomo on Jul 31, 2019 9:31:53 GMT -5
The pediatric angle could and should be amazing, but getting endos on their side will be doubly hard when children are involved. Management better have a plan to address this otherwise even if pediatric approval eventually comes, they are going to run into the exact same hurdles that they have yet to overcome as they are now.
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Post by theshiv on Jul 31, 2019 10:33:38 GMT -5
The pediatric angle could and should be amazing, but getting endos on their side will be doubly hard when children are involved. Management better have a plan to address this otherwise even if pediatric approval eventually comes, they are going to run into the exact same hurdles that they have yet to overcome as they are now. Parents compare notes over just about everything. If this works well for one kid, parents will share with many others with the potential for this information to be widely shared. Parents have demanded medication for their kids in more urgent situations. The key is going directly to parents. MNKD must emphasize that Afrezza works, is easy to use and NO needles. Potential here is big. |
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Post by peppy on Jul 31, 2019 10:43:51 GMT -5
The pediatric angle could and should be amazing, but getting endos on their side will be doubly hard when children are involved. Management better have a plan to address this otherwise even if pediatric approval eventually comes, they are going to run into the exact same hurdles that they have yet to overcome as they are now. If this works well for one kid, parents will share with many others with the potential for this information to be widely shared. Parents have demanded medication for their kids in more urgent situations. The key is going directly to parents. MNKD must emphasize that Afrezza works, is easy to use and NO needles. Potential here is big. agreed, it is the parent and the crying child that will count here. can you imagine being 11 years old and told you need to give yourself a shot 4 times a day? additionally, this is what you get?   |
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Post by joeypotsandpans on Jul 31, 2019 10:48:02 GMT -5
The pediatric angle could and should be amazing, but getting endos on their side will be doubly hard when children are involved. Management better have a plan to address this otherwise even if pediatric approval eventually comes, they are going to run into the exact same hurdles that they have yet to overcome as they are now. Respectfully disagree on both the bolded parts of your statement. If the FDA expands the label to include children ages 4 and older it will be a huge endorsement of safety to the endo's, pediatricians, and others in the medical arena. If the option is there for inhalable and all that comes with it from the Safety and Pharmacokinetics Study in Pediatric Patients, i would say that will continue to work on overcoming some of those "hurdles". |
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Post by mango on Jul 31, 2019 11:45:23 GMT -5
Cheap, effective and creative advertising. I'd say less than 150K, and get Rick or the Count to do it so it airs on national TV—Double Whammy.  |
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Post by wgreystone on Jul 31, 2019 12:43:04 GMT -5
The pediatric angle could and should be amazing, but getting endos on their side will be doubly hard when children are involved. Management better have a plan to address this otherwise even if pediatric approval eventually comes, they are going to run into the exact same hurdles that they have yet to overcome as they are now. Parents compare notes over just about everything. If this works well for one kid, parents will share with many others with the potential for this information to be widely shared. Parents have demanded medication for their kids in more urgent situations. The key is going directly to parents. MNKD must emphasize that Afrezza works, is easy to use and NO needles. Potential here is big. The key is for early adopters to show good results. Just not sure if kids would learn the usage better than adults. |
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Post by peppy on Jul 31, 2019 12:46:36 GMT -5
Parents compare notes over just about everything. If this works well for one kid, parents will share with many others with the potential for this information to be widely shared. Parents have demanded medication for their kids in more urgent situations. The key is going directly to parents. MNKD must emphasize that Afrezza works, is easy to use and NO needles. Potential here is big. The key is for early adopters to show good results. Just not sure if kids would learn the usage better than adults.The parents will. Unless their education level needs "upage." |
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Post by wgreystone on Jul 31, 2019 12:52:17 GMT -5
The key is for early adopters to show good results. Just not sure if kids would learn the usage better than adults.The parents will. Unless their education level needs "upage." That's a good point. Adults usually care more about their kids' health than their owns'. |
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