Bob Azelby, Eliem CEO

Weeks out from an $80M launch, a pain and CNS start­up is back with a fresh raise. Can an IPO be far be­hind?

Not two months af­ter launch­ing out of RA Cap­i­tal’s in­cu­ba­tor, Eliem Ther­a­peu­tics is re­turn­ing to the firm — and oth­ers — to raise an­oth­er heap of cash. And this time, an IPO could po­ten­tial­ly be in the works.

Eliem has put to­geth­er a $60 mil­lion Se­ries B round co-led by RA Cap­i­tal as it seeks to fur­ther ad­vance two lead clin­i­cal can­di­dates across four tri­als. The biotech de­clined an in­ter­view and fur­ther de­clined to com­ment on an emailed ques­tion re­gard­ing fi­nanc­ing plans, sug­gest­ing they may be hun­ker­ing down in prepa­ra­tion for an S-1 fil­ing with the SEC.

Though the Se­ries B proved to be small­er than the $80 mil­lion launch round in March, Eliem has an­nounced $140 mil­lion in funds be­tween the 60-day span of the two an­nounce­ments.

Eliem spawned out of con­ver­sa­tions from RA man­ag­ing di­rec­tor An­drew Levin and long­time pain re­searcher Va­lerie Moris­set, who had re­cent­ly re­tired from biotech to start a new chap­ter in the VC world. Dis­cus­sions re­volved around the pro­drug of an en­do­cannabi­noid known as palmi­toylethanolamide, or PEA, and af­ter ini­tial skep­ti­cism Moris­set agreed to hop on board as pres­i­dent and CSO.

The pro­drug, dubbed ETX-810, is the lead pro­gram in a pipeline of four neu­ro as­sets Eliem even­tu­al­ly hopes to bring to pa­tients. It’s part of a fam­i­ly of en­do­cannabi­noid hope­fuls that have thus far come up short for Big Phar­mas look­ing to in­vest in the area. Part of what drew Moris­set to the com­pa­ny, she told End­points News in March, was the sheer amount of clin­i­cal lit­er­a­ture show­ing how PEA could be used for chron­ic pain con­di­tions.

They’re hope­ful that the pro­drug ap­proach can lead to bet­ter re­sults. ETX-810 is cur­rent­ly in two Phase IIa stud­ies look­ing at di­a­bet­ic pe­riph­er­al neu­ro­path­ic pain and lum­bosacral radic­u­lar pain, and Eliem is now putting timeta­bles on the da­ta read­outs for the first half of 2022.

In ad­di­tion to the pain-re­lat­ed in­di­ca­tions, how­ev­er, Eliem is al­so work­ing on a host of oth­er CNS can­di­dates. Next up be­hind ETX-810 is a GA­BA-pos­i­tive al­losteric mod­u­la­tor, al­so from RA Cap­i­tal, which the com­pa­ny is call­ing ETX-155. Eliem plans to take this pro­gram in­to two Phase IIa stud­ies for ma­jor de­pres­sive dis­or­der and hor­mone-re­lat­ed de­pres­sive dis­or­ders, as well as a Phase Ib tri­al for epilep­sy.

Da­ta here are ex­pect­ed in the sec­ond half of 2022 and the first half of 2023, re­spec­tive­ly.

Fur­ther down the pipeline are two pre­clin­i­cal pro­grams: a Kv7.⅔ chan­nel open­er dis­cov­ered in-house, where Eliem hopes to go in­to pain and epilep­sy, and an­oth­er ear­ly-stage re­search pro­gram po­ten­tial­ly for gen­er­al­ized anx­i­ety and de­pres­sion.

In­ter­me­di­ate Cap­i­tal Group co-led the round with RA Cap­i­tal. Oth­er in­vestors in­clud­ed Ac­cess Biotech­nol­o­gy, Sam­lyn Cap­i­tal, Acorn Bioven­tures and LifeArc.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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