Replies to post #288 on Rezolute Inc. (RZLT)

[Whalatane]

EOT was the data they stopped taking the drug . Then there was a 2 wk follow up to see if there was any lingering benefit ....which they recorded for the 200 mg dose .
The problem is that they say there was probably full cell penetration at the 200 mg dose so there was no benefit from a larger dose ...however ...if there was full cell penetration at the 200 dose ...and the 400 dose ...those graphs should be the same or close .
But they aren't

Kiwi

[Whalatane]

RMB. In the CC the Co thought the difference between the 400 mg and 200 mg dose was that there were more with advanced DME in the 200 mg dose .
So those with limited DME ...more of them in the 400 mg cohort ...saw limited benefit as not a lot to improve on.

So the challenge is to recruit those with moderate DME who aren't yet taking the eye injections

Kiwi

[Whalatane]

Fierce Biotech article on DME trial

Roberts said improvements were more pronounced in patients who had a CST of more than 400 µm at baseline. There were more of those patients, who Roberts classed as having more severe CST, in the 200 mg arm than the other cohorts. While Roberts said baseline CST may explain the results, the biotech is continuing to analyze the data and is yet to settle on an answer.

There was no significant improvement in vision in the study but Rezolute attributed that to the length of the trial, rather than a limitation of the drug candidate. The biotech said the CST changes would predict vision benefits in a longer trial.

“Any drug that gets rid of ... the fluid and gets rid of the thickening of the retina is, almost by definition, going to have visual benefits for the patient. I think in a six-month study, a 12-month study, that would give enough time to the clinical trial to demonstrate effects on the visual acuity.”

Rezolute is now evaluating the next steps for the program. Nevan Charles Elam, the biotech’s CEO, said he will “definitely explore all viable options” but it is unlikely the company will advance into late-stage development independently. A larger partner could explore opportunities identified by Rezolute, such as the potential for a lower dose given over a longer period of time to be efficacious.

Kiwi