Mer­ck falls short in PhI­II Covid-19 pro­phy­lax­is tri­al, join­ing Pfiz­er

Mer­ck took an­oth­er swing at bat to bol­ster its case for its Covid-19 an­tivi­ral — and that swing turned in­to yet an­oth­er miss.

The phar­ma gi­ant said Tues­day morn­ing that its an­tivi­ral mol­nupi­ravir, brand­ed as Lagevrio, failed to show “a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in the risk of COVID-19 fol­low­ing house­hold ex­po­sure to an­oth­er in­di­vid­ual with COVID-19” in a Phase III tri­al.

The study en­rolled more than 1,500 par­tic­i­pants — all who lived with some­one who was new­ly di­ag­nosed with Covid-19. That house­hold mem­ber was al­so show­ing at least one symp­tom or sign of the dis­ease, and had not had said symp­toms for more than five days.

In short, the group tak­ing Lagevrio was 23.6% less like­ly to be in­fect­ed with Covid-19 than those who re­ceived place­bo dur­ing the first 14 days of the study. How­ev­er, Mer­ck said that the pri­ma­ry end­point was not met.

Mer­ck now joins Pfiz­er af­ter the Paxlovid mak­er failed its 3,000-pa­tient tri­al in post-ex­po­sure pro­phy­lax­is last year. Pfiz­er saw risk re­duc­tions of 32% and 37%, de­pend­ing on the du­ra­tion a pa­tient was on Paxlovid to pre­vent in­fec­tion, but none of those num­bers were sta­tis­ti­cal­ly sig­nif­i­cant.

A Mer­ck spokesper­son told End­points News via email that the tri­al was test­ing the an­tivi­ral in adults who start­ed out the study with­out Covid-19, per a neg­a­tive test. The goal was to see how the an­tivi­ral would do in pre­vent­ing pa­tients on the an­tivi­ral treat­ment from con­tract­ing the dis­ease.

Mer­ck wrote that it plans to sub­mit the full re­sults from the study to be pre­sent­ed at an un­named sci­en­tif­ic meet­ing or for pub­li­ca­tion.

Lagevrio has been used far less than its com­peti­tor, Pfiz­er’s Paxlovid — Lagevrio was grant­ed EUA one day af­ter Paxlovid. How­ev­er, that De­cem­ber 2021 au­tho­riza­tion was on­ly for cas­es in which oth­er treat­ments were “not ac­ces­si­ble or clin­i­cal­ly ap­pro­pri­ate.”

While Paxlovid re­duced the risk of hos­pi­tal­iza­tion and death due to Covid-19 by al­most 90%, mol­nupi­ravir’s ef­fi­ca­cy has hov­ered around 30%.

De­spite the lat­est set­back, Mer­ck wrote that it will be do­ing fur­ther study on mol­nupi­ravir in po­ten­tial­ly in­di­ca­tions out­side of Covid-19, cit­ing the pos­si­bil­i­ty of oth­er in­fec­tious dis­eases such as RSV.

The FDA just re­cent­ly axed the re­quire­ment for a pos­i­tive test to get a pre­scrip­tion for ei­ther Paxlovid or Lagevrio — on­ly re­quir­ing a mild-to-mod­er­ate Covid-19 di­ag­no­sis.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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