Tim Dyer, Addex Therapeutics CEO

As Covid-re­lat­ed chal­lenges weigh on pa­tient re­cruit­ment, biotech scraps PhI­Ib/III Parkin­son's pro­gram

More than two years af­ter lit­tle Swiss biotech Ad­dex Ther­a­peu­tics post­poned a Phase IIb/III tri­al in­def­i­nite­ly due to the then-nascent Covid-19 pan­dem­ic, it’s throw­ing in the tow­el.

As with two years ago, Covid was to blame.

“We took this de­ci­sion be­cause it was not fea­si­ble to con­tin­ue the study at such a slow re­cruit­ment rate in the cur­rent en­vi­ron­ment. I’d like to em­pha­size that it was not dipraglu­rant re­lat­ed and we con­tin­ue to be­lieve in the po­ten­tial of this com­pound as a treat­ment for PD-LID,” CEO Tim Dy­er said in a state­ment.

Ad­dex shares $ADXN on Nas­daq sunk about 47.5% in pre-mar­ket trad­ing Fri­day.

The com­pa­ny had hoped to test dipraglu­rant, a neg­a­tive al­losteric mod­u­la­tor of mGlu5, as a po­ten­tial treat­ment for the un­con­trolled, in­vol­un­tary move­ment as­so­ci­at­ed with lev­odopa use in Parkin­son’s pa­tients. But these pa­tients were al­so at high risk for Covid-19, which led to con­cerns about par­tic­i­pa­tion in clin­i­cal stud­ies, ac­cord­ing to Ad­dex.

Cou­pled with staffing short­ages and turnover with­in study sites, the com­pa­ny said pa­tient re­cruit­ment took a big hit.

A clin­i­cal­tri­als.gov post­ing not­ed an ac­tu­al study start date last Au­gust, with a tar­get en­roll­ment of 140 pa­tients and es­ti­mat­ed com­ple­tion in Au­gust 2023.

Found­ed in 2002, Ad­dex is fo­cused on oral­ly avail­able small mol­e­cule drugs that al­loster­i­cal­ly mod­u­late tar­gets for neu­ro­log­i­cal dis­or­ders. While the dipraglu­rant pro­gram in Parkin­son’s had been among its most ad­vanced, it’s al­so de­vel­op­ing a mGlu2 pos­i­tive al­losteric mod­u­la­tor to treat epilep­sy in part­ner­ship with J&J’s Janssen, while In­di­v­ior li­censed its GABAB pos­i­tive al­losteric mod­u­la­tor for sub­stance use dis­or­der.

“We now plan to fo­cus on ad­vanc­ing our pre­clin­i­cal port­fo­lio to­wards the clin­ic and pur­su­ing strate­gic col­lab­o­ra­tions for se­lect­ed pro­grams, while we con­cur­rent­ly fo­cus on de­liv­er­ing un­der our strate­gic part­ner­ship with In­di­v­ior,” Dy­er added. “Our strate­gic part­ner, Janssen is al­so ex­pect­ed to de­liv­er da­ta from the Phase 2 study of ADX71149 in epilep­sy pa­tients in the fourth quar­ter of this year.”

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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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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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: Roche scraps one of two schiz­o­phre­nia PhII tri­als due to missed pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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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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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

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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