Eliem delays a depression trial, indefinitely postpones another after blaming CMC issues for low drug exposure
In the drug R&D world, plans are not set in stone, as Eliem Therapeutics exhibited Monday with shifts to its depression strategy.
The Seattle-UK biotech originally wanted to start two mid-stage depression trials this year but will have to delay one — in major depressive disorder — until next year and indefinitely postpone the other in perimenopausal depression. Back in April, Eliem delayed the launches of both Phase IIa trials because the biotech was curious as to why the exposure was lower than expected in a Phase Ib study, which tried to prove out the concepts of ETX-155 in photosensitive epilepsy.
Now, with results from an initial review, the biotech thinks certain parts of the CMC are “most likely” to blame for the reduced exposure levels. The company thinks there might have been differences between the batches of drug used in Phase I trials and the Phase Ib PSE study.
With that info in hand, Eliem will take the GABAa positive allosteric modulator through another Phase I pharmacokinetic trial using the drug batches that were used in the PSE study. The biotech plans to find out which dose will provide a similar exposure to the 60 mg dose used in the 14-day repeat dose healthy volunteer study previously conducted.
Results from that trial are slated for the fourth quarter, and then a randomized, placebo-controlled Phase IIa in MDD patients will kick off the first quarter of the new year. The mid-stage trial will test the drug as a four-week treatment, with topline data to come through in mid-2024.
Meanwhile, the other depression trial is being postponed to “provide additional investment flexibility for the progression of Eliem’s pipeline,” the biotech said Monday. Eliem will consider resuming the Phase Ib PSE trial after the pharmacokinetic study later this year.
“We are encouraged by the precedent validation of the GABAA PAM class in multiple large depression trials and believe ETX-155 has the potential to be a clinically differentiated GABAA PAM product candidate,” Eliem CEO and president Bob Azelby said in a statement.
Eliem is among a crop of biopharmas attempting to get a new MDD drug across the finish line, with Axsome reporting its long-delayed shot is back up for labeling discussions at the FDA. Xenon, Praxis and Biogen and Sage are among others in the field. Praxis’s drug failed to pass muster in a Phase II/III study last month.
The depression news comes weeks, or a few months at most, before Eliem will provide an update on its other clinical-stage asset, ETX-810. The prodrug failed a mid-stage study in April in patients with diabetic peripheral neuropathic pain, but another Phase II study is slated to read out this quarter in patients with lumbosacral radicular pain, or sciatica.
