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Post by therealisaching on Jun 7, 2018 8:08:39 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 kite on Jun 7, 2018 8:10:01 GMT -5
This is great news!
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Post by mnholdem on Jun 7, 2018 8:10:51 GMT -5
Where is sla55 and what have you done with her?  |
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Post by therealisaching on Jun 7, 2018 8:12:25 GMT -5
haha. Love Sla. Had to post 1st once
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Post by tw12 on Jun 7, 2018 8:12:45 GMT -5
Clutch in, shifter down, give it a little gas, release clutch, accelerate nice 'n smoothly into second gear...
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Post by mnholdem on Jun 7, 2018 8:15:31 GMT -5
Study achieved primary endpoint of safety and tolerability
- Progressive dosing of Treprostinil Technosphere (TreT) significantly exceeded the corresponding peak plasma and exposure levels of the maximum recommended dose of Tyvaso® Inhalation Solution
- Achieved a maximum tolerated dose with no serious adverse events reported
Source: investors.mannkindcorp.com/news-releases/news-release-details/mannkind-successfully-completes-phase-1-trial-treprostinil
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"Significantly exceeded" maximum recommended dose of Tyvaso® Inhalation Solution. It appears that MannKind CMO David Kendall MD understands the value of publishing comparisons against the competition.
“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.” - David Kendall, Chief Medical Officer of MannKind
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Post by centralcoastinvestor on Jun 7, 2018 8:16:58 GMT -5
This is fantastic news. This helps MannKind to be recognized as a multi drug company.
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Post by hellodolly on Jun 7, 2018 8:17:19 GMT -5
//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.//
Fingers are crossed.
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Post by kc on Jun 7, 2018 8:29:19 GMT -5
It takes time to turn a ship around. But Mike has done a great job of building a team to move mannkind towards the future.
The best is yet to come.
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Post by centralcoastinvestor on Jun 7, 2018 8:41:05 GMT -5
This event truly opens the door for a partnership for Trepostinil. This also opens a completely new front for the shorts to have to worry about. The MannKind story keeps getting better and better.
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Post by #NoMoreNeedles on Jun 7, 2018 8:43:26 GMT -5
Third trick pony show: Dronabinol (Andrea Leone-Bay with RLS)
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Post by gareaudan on Jun 7, 2018 8:57:32 GMT -5
do I remember correctly that when trepT suddenly replaced epi , some thought that it was because it was easier to partner or sale and that we might already have someone waiting to see if the product was safe. So, now that we proved that the product is safe, what are the chances that we sale the right instead of waiting the end of the studies and how much could it worth at this point?
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Post by uvula on Jun 7, 2018 9:02:59 GMT -5
The chances are better today than they were yesterday!
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Post by gareaudan on Jun 7, 2018 9:07:50 GMT -5
The chances are better today than they were yesterday! haha! Thanks uvula...Makes me feel happy 😀 |
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Post by boca1girl on Jun 7, 2018 9:09:12 GMT -5
do I remember correctly that when trepT suddenly replaced epi , some thought that it was because it was easier to partner or sale and that we might already have someone waiting to see if the product was safe. So, now that we proved that the product is safe, what are the chances that we sale the right instead of waiting the end of the studies and how much could it worth at this point? I believe we will have a “partner” on TrepT in the near future, before Phase 3 trials are completed, maybe even before they are started. |
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