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Post by mango on Jun 7, 2018 9:13:06 GMT -5
investors.mannkindcorp.com/news-releases/news-release-details/mannkind-successfully-completes-phase-1-trial-treprostinil
WESTLAKE VILLAGE, Calif., June 07, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation(Nasdaq:MNKD) today announced that it has completed a Phase 1 clinical study of Treprostinil Technosphere (TreT) under an Investigational New Drug application filed with the Food and Drug Administration. The key highlights of this study are: Ability to deliver TreT within 1-2 inhalations in <10 seconds Maximum tolerated dose is expected to be able to deliver higher plasma concentrations above the reported data for the current commercially available inhaled treprostinil Based on these data, MannKind is preparing the next phase of development to evaluate the safety and tolerability of TreT in patients with PAH Data will be submitted to be presented at an upcoming conference “We are pleased to have completed the TreT Phase 1 trial, which met the study’s safety, tolerability and pharmacokinetics objectives,” stated David Kendall, Chief Medical Officer of MannKind. “We are excited to utilize our existing technology platform and device capabilities to create an easy-to-use and tolerable formulation of treprostinil to help unmet patient needs in a serious chronic disease such as PAH.” TreT is proposed as a drug-device combination product for the treatment of patients with pulmonary arterial hypertension (PAH), utilizing a small, portable, breath-powered inhaler that is intended to simplify drug dosing. The regulatory and development pathway is expected to be capital efficient, using existing safety data of the component API to reduce Phase 3 requirements to a pivotal safety and efficacy trial and a pivotal bioequivalency trial. The regulatory submission in the United States is expected to utilize the 505(b)(2) pathway. “People living with PAH need more convenient and tolerable treprostinil treatment options to help them live a less intrusive lifestyle. I am excited to see that MannKind was safely able to achieve higher plasma levels than reported for the current standard of care using Technosphere-based treprostinil,” stated Lewis Rubin, MD, Emeritus Professor of Medicine at the University of California, San Diego School of Medicine. This was a single site study with 48 healthy, normal subjects enrolled in 8 cohorts of 6 subjects each. The treatments were intended to establish the maximum tolerated dose, starting at 30 mcg. Each subject received one dose of TreT by oral inhalation during the treatment period. A total of 12 pharmacokinetic blood samples were collected from each subject. Plasma pharmacokinetic samples were analyzed for treprostinil. The primary objective of the Phase 1 clinical study was to investigate the safety, tolerability, and pharmacokinetics of TreT in healthy volunteers after dosing by oral inhalation. Secondary endpoints include the evaluation of systemic exposure and pharmacokinetics of TreT, including dose proportionality. For more information about the study, please visit www.ClinicalTrials.gov. 🎊🎉💥☀️🕺🏻
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Post by mango on Jun 7, 2018 9:19:59 GMT -5
MannKind's trepostinil is headed toward the Standard of Care.
🏆😀🙃
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Post by uvula on Jun 7, 2018 9:26:25 GMT -5
Once the drug gets into the bloodstream the technosphere is done doing its job. They already proved that the drug does get into the bloodstream. The drug itself is the same as the drug that is currently used. The upcoming clinical trials are as close to a sure thing as you can get.
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Post by gareaudan on Jun 7, 2018 9:37:17 GMT -5
Ok, here is a more specific question than my last one. what would you prefer between selling trepT for 50 M$ to 100M$ ( these numbers are based on nothing and are for the sole purpose of discussion) to help financing afrezza or keep it and have the possibilities to make more after 2020. At this point, I would prefer have enough money to push afrezza than another product in the pipeline.
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Post by barnstormer on Jun 7, 2018 9:42:29 GMT -5
Mike said at ASM he wanted a partner for TrepT. Passing P 1 was probably a contigency of the term sheets he spoke of. Partner = cash non dilutive.
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Post by ilovekauai on Jun 7, 2018 9:44:36 GMT -5
Yay! What a nice surprise to awaken to as I sip my morning tea and contemplate my day. Onwards!
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Post by dg1111 on Jun 7, 2018 9:47:57 GMT -5
investors.mannkindcorp.com/static-files/68db8814-e4f3-46f4-ab26-d31b6a7fb0bd Slide 25 of the linked presentation provides a schedule for "TreT Development Program." The schedule does not explicitly state a completion for phase 1. It shows "Anticipated Readout" being 2Q-3Q. Is it fair to say that we are ahead of schedule on completion of phase 1? I wish sales were picking up faster, but this management team does a much better job at delivering when they say they will.
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Post by Deleted on Jun 7, 2018 9:48:55 GMT -5
Mike said at ASM he wanted a partner for TrepT. Passing P 1 was probably a contigency of the term sheets he spoke of. Partner = cash non dilutive. Assume that a separate production line would be installed in Danbury for this product? How many different dosages would need to be made? Correct me if my memory is wrong: Existing product requires 8-12 daily doses from a large device and annual cost is around $125K. Lastly, is there some orphan status to this therapeutic class and if so, what are the ramifications?
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Post by bill on Jun 7, 2018 9:49:30 GMT -5
Ok, here is a more specific question than my last one. what would you prefer between selling trepT for 50 M$ to 100M$ ( these numbers are based on nothing and are for the sole purpose of discussion) to help financing afrezza or keep it and have the possibilities to make more after 2020. At this point, I would prefer have enough money to push afrezza than another product in the pipeline. gareaudan - Maybe MNKD can have both; a trepT partner with enough up-front cash to fund Afrezza and a cut of the downstream revenue if it becomes wildly successful. After all, won't MNKD still be the manufacturer even if they "sell" it to someone else?
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Post by mango on Jun 7, 2018 9:58:08 GMT -5
“People living with PAH need more convenient and tolerable treprostinil treatment options to help them live a less intrusive lifestyle. I am excited to see that MannKind was safely able to achieve higher plasma levels than reported for the current standard of care using Technosphere-based treprostinil,” stated Lewis Rubin, MD, Emeritus Professor of Medicine at the University of California, San Diego School of Medicine.
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Post by mike0475 on Jun 7, 2018 10:15:17 GMT -5
Employee plan stock plan announced first then this study update Cleaning house and clearing the way...
Will we see more stock dilution if these trends and developments continue w Brazil soon, India, who else?
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Post by babaoriley on Jun 7, 2018 10:15:21 GMT -5
Once the drug gets into the bloodstream the technosphere is done doing its job. They already proved that the drug does get into the bloodstream. The drug itself is the same as the drug that is currently used. The upcoming clinical trials are as close to a sure thing as you can get. Hey, J, I'm going to try as hard as I can to imagine you did not say that!
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Post by therealisaching on Jun 7, 2018 10:16:23 GMT -5
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Post by babaoriley on Jun 7, 2018 10:18:27 GMT -5
“People living with PAH need more convenient and tolerable treprostinil treatment options to help them live a less intrusive lifestyle. I am excited to see that MannKind was safely able to achieve higher plasma levels than reported for the current standard of care using Technosphere-based treprostinil,” stated Lewis Rubin, MD, Emeritus Professor of Medicine at the University of California, San Diego School of Medicine. San Diego School of Medicine? Hmmm, too close to Mexico for my taste!
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Post by babaoriley on Jun 7, 2018 10:20:00 GMT -5
Oh, perhaps you weren't aware that Mike and David recruited a bunch of test subjects at the Annual Meeting - shareholders were falling over each other to volunteer!
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