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.”

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

Roche ditch­es fi­nal PhI­II for can­cer hope­ful, re­ports set­back for key drug in $1.4B buy­out

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials.

Now, the last piece of the program is gone.

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