Pediatric INHALE-1 Trial

[myocat]

The data readout should be February/March 2022.  Hope it comes sooner.


"INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension.

The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events."

[oldfishtowner]

Nov 16, 2021 16:23:07 GMT -5 myocat said:

The data readout should be February/March 2022.  Hope it comes sooner.


"INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension.

The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events."

How so? MNKD announced the first participant enrollment early last month.    When there will be meaningful data to read out depends on how quickly MNKD completes enrollment. 

I did not hear Castagna mention anything at the earnings CC on how enrollment was progressing.  Surely when enrollment is complete MNKD will make an announcement.  Then maybe we can estimate when data from the trial will be available.

Also, since this is an open label study, results may leak out well before there is a formal data readout or any formal announcement of results.