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.

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.

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.