Eliem in Hot Water Following Disappointing Trial Data
Bob Azelby, Eliem Therapeutics CEO /Doug Pensinger via Getty Images
Eliem Therapeutics could be in trouble following the announcement that its drug candidate ETX-810, intended to treat diabetic peripheral neuropathic pain, did not meet its primary endpoint. Following the news, the company’s stock dropped 54% in just a few hours.
Eliem emerged from stealth mode in March 2021 with $80 million in investments, which was later bolstered by an additional $60 million in May 2021. The company intended to use some of the funds in the development of ETX-810, a non-opioid new chemical entity that was hopeful of treating diabetic peripheral neuropathic pain and pain resulting from sciatica. More broadly, the drug was intended to address the shortfalls of other pain therapies across a variety of chronic pain conditions.
The science of ETX-810 is based on an endogenous bioactive lipid known as palmitoylethanolamide (PEA). PEA has been frequently evaluated in clinical studies hoping to provide new treatments for chronic pain because it is able to modulate neuroinflammation and pain signaling. Although PEA has been widely studied as a treatment for pain patients, there are currently no approved PEA-based therapeutics, and the drug is only available as a dietary supplement, which has overall poor drug-like properties.
Eliem was hopeful about bringing the first PEA-based therapeutic to the market and hosted a virtual investor event in February 2022, which provided an in-depth review of ETX-810 and its promise to meet unmet needs in chronic pain treatment. The company proffered ETX-810’s potential commercial opportunity and touted existing data that supported the mechanism of the drug. In its year-end 2021 financial results, Eliem reported that its research and development expenses were $23.3 million for the year.
Unfortunately, ETX-810 did not pan out in its clinical trials. In the Phase IIa trial which enrolled 79 patients with diabetic peripheral neuropathic pain, the drug failed to outperform the placebo in its primary endpoint of improving daily pain.
“We are obviously disappointed with the results of this proof-of-concept trial of ETX-810,” Bob Azelby, president and CEO of Eliem said in a press release. “We believe all aspects of this trial were well-executed, with appropriate patient selection, well-balanced study arms, and placebo effect in line with expectations, so we are confident that the results are unambiguous and that there is not currently a development path forward in DPNP for ETX-810.”
Azelby is still hopeful that the drug may meet its primary endpoint in trials evaluating its effectiveness in patients with sciatica pain, and results are anticipated to be shared from that trial in the third quarter of 2022.
However, with its lead asset down and stock dropping, Eliem may be in for a turbulent future. The company has already chosen to delay enrollment in its clinical trial evaluating ETX-155 in the treatment of major depressive disorder, perimenopausal depression and focal onset seizures. Eliem previously submitted an Investigational New Drug Application to the U.S. Food and Drug Administration and was geared up to complete a Phase IIa trial. The decision to delay comes after a review of interim data from the ongoing Phase Ib trial of the drug in photosensitive epilepsy, which was inconclusive.
With investments hinging on a drug no longer in play in one of its indications and a delayed trial in its other lead asset, Eliem might get to work on developing some of its candidates that are in preclinical phases. The company is developing a Kv7 channel opener for the treatment of pain, epilepsy and depression and a next-generation anxiolytic intended to treat generalized anxiety disorder. Information about both preclinical programs is limited.