Men­lo’s IPO hang­over be­gins with a failed PhII for an old Mer­ck castoff

Ste­va Bas­ta

Just a lit­tle more than two months af­ter Men­lo Ther­a­peu­tics went pub­lic $MN­LO, rais­ing $119 mil­lion from a suc­cess­ful IPO in the midst of a rol­lick­ing good time on Wall Street for high risk of­fer­ings, their one and on­ly drug in the clin­ic just de­ci­sive­ly failed a Phase II tri­al.

In­ves­ti­ga­tors say that ser­lop­i­tant failed to dis­tin­guish it­self from a place­bo in a pru­ri­tus study with 484 pa­tients, flunk­ing the pri­ma­ry and key sec­ondary end­points. Ex­ecs for the com­pa­ny, though, are vow­ing to hang on, not­ing some ear­li­er pos­i­tive mid-stage da­ta as well as a Phase III that is about to launch.

Many of the in­vestors, though, won’t be stay­ing for the next chap­ter. The biotech’s stock dropped more than 70% this morn­ing as a sav­age post-IPO hang­over set in.

Men­lo got the NK-1 re­cep­tor an­tag­o­nist from Mer­ck back in 2012 for on­ly $1 mil­lion up­front, an ear­ly ex­am­ple of a de­vel­op­er that bagged a drug from Big Phar­ma’s back shelves cheap. In this case the team felt that the drug could be re­pur­posed for itch as­so­ci­at­ed with der­ma­to­log­ic con­di­tions such as atopic der­mati­tis, pso­ri­a­sis and pruri­go nodu­laris. At Mer­ck this drug was known as MK0594, which was put through a cou­ple of tri­als for al­co­hol de­pen­dence (ter­mi­nat­ed) and over­ac­tive blad­der.

Men­lo based its IPO on two Phase II stud­ies that were re­port­ed out last Sep­tem­ber. In­ves­ti­ga­tors re­port­ed a bor­der­line suc­cess (p<0.05) on the re­duc­tion from base­line VAS pru­ri­tus score and a change from base­line in av­er­age-itch VAS score at 8 weeks (p<0.001).

Men­lo went pub­lic right along­side Sol­id Bio, which has seen its shares crash in the wake of an FDA hold on its Duchenne mus­cu­lar dy­s­tro­phy ther­a­py. The big ques­tion is how many nasty set­backs like this will have to oc­cur to new­ly pub­lic com­pa­nies be­fore in­vestors lose their ap­petite for high risk. And af­ter the Ax­o­vant im­plo­sion on Alzheimer’s with a cheap drug bagged from Glax­o­SmithK­line, oth­ers may be ques­tion­ing the Big Phar­ma bar­gain base­ment strat­e­gy.

Vi­vo Cap­i­tal owned the biggest chunk of shares ahead of the IPO, with 17.3% of the eq­ui­ty, fol­lowed by Remedi­tiex and Pre­sidio. Mer­ck owned 5.8% as part of its deal with the biotech, with ven­Bio and F-Prime in on the syn­di­cate.

“Re­duc­tion of pru­ri­tus has been demon­strat­ed in two pri­or Phase II stud­ies, one tri­al in pa­tients with chron­ic pru­ri­tus and one tri­al in pa­tients with pruri­go nodu­laris,” said Men­lo CEO Steve Bas­ta in a state­ment. “We are ini­ti­at­ing Phase III stud­ies in pruri­go nodu­laris this quar­ter, and we are look­ing for­ward to the Phase II re­sults in re­frac­to­ry chron­ic cough in the fourth quar­ter of this year, and the Phase II re­sults in pru­ri­tus as­so­ci­at­ed with pso­ri­a­sis by late 2018 or ear­ly 2019.”

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.