Al­ler­gan dou­bles down on NM­DA de­pres­sion drug de­vel­op­ment ef­forts, bag­ging an op­tion to a small mol­e­cule fol­lowup drug

Close to three years af­ter Al­ler­gan $AGN swooped in to buy Nau­rex and its NM­DA drug for de­pres­sion for $560 mil­lion in cash, help­ing spin out the orig­i­nal team in­to a new biotech dubbed Aptinyx, the two have fol­lowed up with an op­tion deal on a small mol­e­cule fol­low-up pro­gram.

Nor­bert Riedel

Al­ler­gan has so far clear­ly en­joyed its late-stage work on ra­pastinel, an IV drug which the FDA des­ig­nat­ed a break­through ther­a­py for ma­jor de­pres­sion. NM­DA has been a tar­get for years in the R&D crowd fo­cused on de­pres­sion, and Aptinyx CEO Nor­bert Riedel has steered a course to prov­ing that his re­searchers found the ther­a­peu­tic strat­e­gy for get­ting it right.

Just last fall Riedel scored a $70 mil­lion round for his spin­out, which put Bain’s Adam Kop­pel on the board.

There’s no im­me­di­ate word on ex­act­ly how much Al­ler­gan is pay­ing for the small mol­e­cule fol­low-up to the IV ther­a­py, which is called AGN-241751.

David Nichol­son, Al­ler­gan

Al­ler­gan’s ef­forts on de­pres­sion come as a va­ri­ety of biotechs are jock­ey­ing for po­si­tion in search of ap­provals. Alk­er­mes $ALKS was ini­tial­ly stiff-armed on its ap­pli­ca­tion af­ter its lead de­pres­sion drug went 1 for 3 in Phase III, un­der­scor­ing just how hard it is to il­lus­trate suc­cess against high place­bo re­spons­es. And J&J $JNJ is hop­ing to score soon with a pitch on es­ke­t­a­mine, its low dose ver­sion of a horse tran­quil­iz­er that is bet­ter known as Spe­cial K on the par­ty scene. Sage $SAGE, mean­while, has man­aged to at­tract con­sid­er­able at­ten­tion for its work on post­par­tum de­pres­sion, de­spite stick­ing with small study pop­u­la­tions.

Al­ler­gan CEO Brent Saun­ders be­lieves he has good odds in this race.

“Ra­pastinel is a great drug that we have at Phase III,” Saun­ders told Jim Cramer a few weeks ago. “We’ll get the da­ta [in the] ear­ly part of next year. It could be an ab­solute game-chang­er for de­pres­sion.”

“Through our pro­duc­tive re­search col­lab­o­ra­tion with Aptinyx and par­al­lel de­vel­op­ment of ra­pastinel, we have gained im­por­tant in­sights in­to NM­DA re­cep­tor mod­u­la­tion as a po­ten­tial ther­a­peu­tic ap­proach for de­pres­sion,” said David Nichol­son, the chief R&D of­fi­cer at Al­ler­gan. “We plan to ad­vance AGN-241751 for the treat­ment of MDD and be­lieve its phar­ma­co­log­i­cal pro­file will en­able it to be­come an oral com­ple­ment to ra­pastinel, fur­ther bol­ster­ing our pipeline of ther­a­peu­tics ad­dress­ing ar­eas of sig­nif­i­cant un­met med­ical need.”

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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David Marek, Myovant

My­ovant beefs up da­ta pack­age in NDA #3, boost­ing its case for longterm dos­ing of Pfiz­er-part­nered re­l­u­golix

When Pfizer handed over $650 million in cash to partner on Myovant’s relugolix, the pharma giant made clear that the deal — valued at $4.2 billion total — was just as much about the approved indication of prostate cancer as the two women’s health conditions the drug could treat.

A month later, the two companies are offering another glimpse of the therapy’s longterm potential in endometriosis.

Look­ing to win over some skep­ti­cal an­a­lysts, Rhythm beats the drum on in­ter­im da­ta in PhII bas­ket study for ad­di­tion­al in­di­ca­tions

Rhythm Pharmaceuticals has been working toward expanding the FDA approval they received just two months ago for three rare genetic disorders that result in obesity. In December, their Phase III cut of data saw mixed reactions from analysts, but new interim results released Tuesday may provide more excitement.

In an ongoing Phase II study for setmelanotide across individuals with one of three distinct rare genetic diseases of obesity, 65 patients had reached the Dec. 17 cutoff date for evaluation. Among patients who met the primary endpoint of at least 5% weight loss over three months, Rhythm saw an average reduction of no less than 7.1% in any of the groups.