ELIEM THERAPEUTICS, INC. Item 8.01 Other Items.
On
Update on ETX-810
In the Phase 2a clinical trial in DPNP, ETX-810 did not achieve statistically significant separation from placebo on the trial's primary endpoint, which assessed the change from baseline to week 4 in the weekly average of the daily pain score measured with the Pain Intensity Numerical Rating Scale (PI-NRS).
The multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluated the efficacy and safety of ETX-810 in 159 subjects with DPNP over four weeks of dosing. 78 patients received 1,000 mg of ETX-810 twice daily, and 81 patients received placebo. ETX-810 was well tolerated in the study, with an encouraging safety profile. However, the primary endpoint of the study was not achieved, and separation from placebo on the PI-NRS was not observed during the 4 weeks of dosing. As a result, Eliem does not currently plan to further develop ETX-810 as a potential treatment for DPNP.
The Company has also fully enrolled its Phase 2a proof-of-concept trial evaluating ETX-810 in patients with LSRP. The LSRP study has enrolled 149 patients and has a similar design to the Phase 2a DPNP study. The LSRP study is expected to report topline data in the third quarter of 2022.
Update on ETX-155
ETX-155 is in an ongoing Phase 1b proof-of-concept trial in photosensitive
epilepsy (PSE). Last month, the Company received clearance from
Eliem has reviewed interim results from the Phase 1b PSE study and has elected to delay enrollment of its Phase 2a clinical trials of ETX-155 in major depressive disorder (MDD) and perimenopausal depression (PMD). Three patients have been evaluated to date in the Phase 1b PSE study, and the results of ETX-155 on the photoparoxysmal response observed following intermittent photic stimuli were inconclusive. An analysis of the drug exposures in these patients indicated that drug levels were significantly lower than expected based on the pharmacokinetic profile observed in the two Phase 1 trials of ETX-155 in healthy subjects. The Company is currently investigating potential root causes of the observed difference in exposure from the prior studies, including evaluation of any differences between the lots of drug product used in this study and those of the prior Phase 1 trials. The Company will provide an update to timelines after the root cause is further investigated.
This Current Report on Form 8-K contains forward-looking statements, including,
without limitation, statements relating to: the continued development and
clinical and therapeutic potential ETX-155 and ETX-810; the progression of
Eliem's clinical trials of ETX-155 and the timing thereof; and the anticipated
data readouts of ETX-810 in LSRP and the timing thereof. Words such as
"expected," "plan," "potential," "will," or other similar expressions identify
forward-looking statements, but the absence of these words does not necessarily
mean that a statement is not forward-looking. In addition, any statements that
refer to expectations, projections or other characterizations of future events
or circumstances are forward-looking statements. The forward-looking statements
in this Current Report on Form 8-K are based upon Eliem's current plans,
assumptions, beliefs, expectations, estimates and projections, and involve
substantial risks and uncertainties. Actual results and the timing of events
could differ materially from those anticipated in the forward-looking statements
due to these risks and uncertainties as well as other factors, which include,
without limitation: the clinical, therapeutic and commercial value of ETX-810,
ETX-155 and Eliem's preclinical programs; risks related to the potential failure
of ETX-810 and ETX-155 to demonstrate safety and efficacy in clinical testing;
Eliem's ability to initiate and conduct clinical trials and studies of ETX-810
and ETX-155 sufficient to achieve a positive completion; the availability of
data at the expected times; Eliem's ability to obtain and protect intellectual
property rights, and operate without infringing on the intellectual property
rights of others; the uncertain timing and level of expenses associated with
Eliem's preclinical and clinical development activities; the sufficiency of
Eliem's capital and other resources; risks and uncertainties related to
regulatory application, review and approval processes and Eliem's compliance
with applicable legal and regulatory requirements; market competition; changes
in economic and business conditions; impacts on Eliem's business due to external
events, including health pandemics or other contagious outbreaks, such as the
current COVID-19 pandemic; and other factors discussed under the caption "Risk
Factors" in Eliem's Annual Report on Form 10-K for the year ended
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be set forth in Eliem's other reports and filings it will make with the
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