Eliem says earlier drug exposure issues have been resolved, drops one epilepsy indication
After being forced to delay two Phase IIa trials and blaming CMC issues on a Phase Ib miss, Eliem Therapeutics believes it’s now in the clear.
The Seattle and UK-based biotech put out word Wednesday morning about how it conducted new early-stage studies to confirm why low exposure issues arose during the Phase Ib. After researchers compared the results of the studies, Eliem found “no meaningful difference” between them and ruled out CMC as the reason for the foiled Phase Ib study, the company said in a press release.
Though the company still plans to move forward in major depressive disorder, it will no longer pursue photosensitive epilepsy — the condition where the low exposure was first observed — as an indication. It will continue to look at focal onset seizures, however.
“We believe we are now well positioned to evaluate the efficacy and safety of ETX-155 in patients with MDD,” CEO Bob Azelby said in the release, referring to the program’s name.
Eliem’s update didn’t do much to persuade investors, as company shares $ELYM fell about 2% in early Wednesday trading.
The biotech had been aiming to start the Phase IIa trials sometime this year, but after the Phase Ib trial came in with lower exposure than expected in patients with photosensitive epilepsy, execs were forced to delay. That happened back in April, and Eliem blamed CMC concerns over the summer following an initial review.
In order to move forward, the biotech says it will still need to conduct a couple more Phase I studies to confirm the pharmacokinetic findings. Eliem plans to run a healthy volunteer study at a higher dose (75 mg) than used in the epilepsy trial (60 mg). If everything goes well, it will take the 75 mg dose into the Phase IIa MDD trial.
A start date isn’t set in stone yet, but Eliem says it hopes to launch in the first quarter of 2023, after which a topline readout would follow in mid-2024.
Eliem has a lot riding on ETX-155 after it scrapped its former lead program a few months ago. In April, the biotech revealed a non-opioid pain drug failed a Phase II, and it made the decision to punt in August.