Mar 15, 2021

Nicole DeFeudis Associate Editor As pres­sure ris­es to ad­dress the su­per­bug cri­sis, Melin­ta Ther­a­peu­tics says it now has a more con­ve­nient op­tion to treat those with an­tibi­ot­ic-re­sis­tant skin in­fec­tions. Chris­tine Ann Miller Melin­ta got the OK for a new-and-im­proved for­mu­la­tion of its an­tibi­ot­ic ori­ta­vancin in acute bac­te­r­i­al skin and skin struc­ture in­fec­tions (AB­SS­SI) caused by sus­cep­ti­ble iso­lates of Gram-pos­i­tive mi­croor­gan­isms, in­clud­ing MR­SA, the com­pa­ny an­nounced on Mon­day. The drug, mar­ket­ed as Kimyr­sa, can be ad­min­is­tered over one hour as op­posed to Melin­ta’s ear­li­er Or­bac­tiv, which takes three. “We have re­spond­ed to the re­quests of the med­ical com­mu­ni­ty to pro­vide an ori­ta­vancin prod­uct with a short­er in­fu­sion time,” CEO Chris­tine Ann Miller said in a state­ment. “We be­lieve that with the ap­proval of KIMYR­SA and prod­uct avail­abil­i­ty this sum­mer, physi­cians and pa­tients will now have a com­pelling new one-dose al­ter­na­tive to the cur­rent stan­dard of mul­ti-dose reg­i­mens for AB­SS­SI.” Ori­ta­vancin’s long jour­ney to ap­proval, be­gin­ning in Eli Lil­ly’s pipeline, is rep­re­sen­ta­tive of the state of af­fairs in an­tibi­otics, a high-risk field from which Big Phar­ma re­treat­ed years ago. Many an­tibi­otics fail in de­vel­op­ment, while oth­ers with­er on the vine due to a lack of avail­able fund­ing. And for the ones that do make it to mar­ket, it’s an up­hill bat­tle against cur­rent­ly ex­ist­ing op­tions and cheap gener­ics. Lil­ly sold the world­wide rights to ori­ta­vancin to In­ter­Mune in 2001. Four years lat­er, In­ter­Mune sold the drug to Tar­gan­ta Ther­a­peu­tics, which was on the hunt for “crit­i­cal­ly need­ed” an­tibi­otics to treat an­tibi­ot­ic-re­sis­tant in­fec­tions. In 2008, though, the FDA sent Tar­gan­ta back to the clin­ic, is­su­ing it a CRL for ori­ta­vancin in com­pli­cat­ed skin and skin struc­ture in­fec­tions. The fol­low­ing year, The Med­i­cines Com­pa­ny lined up a $42 mil­lion deal to buy out Tar­gan­ta and the Phase III drug. “We be­lieve that ori­ta­vancin can be­come an im­por­tant an­ti-in­fec­tive for se­ri­ous in­fec­tions in­volv­ing dif­fi­cult-to-treat bac­te­ria in dif­fi­cult-to-treat hos­pi­tal­ized pa­tients,” the com­pa­ny an­nounced. “Many of those crit­i­cal­ly ill pa­tients are the same pa­tients treat­ed with our ex­ist­ing prod­ucts.” The FDA ap­proved ori­ta­vancin in 2014 for AB­SS­SIs caused by sus­cep­ti­ble Gram-pos­i­tive bac­te­ria, based on two tri­als dubbed SO­LO I and SO­LO II. The SO­LO tri­als com­pared ori­ta­vancin to van­comycin, an­oth­er Lil­ly orig­i­nal that’s now in the hands of ANI Phar­ma­ceu­ti­cals. The stud­ies showed that one 1,200 mg dose of ori­ta­vancin worked just as well as sev­en to 10 days of twice-dai­ly van­comycin treat­ments, ac­cord­ing to Melin­ta. In 2017, Melin­ta ex­e­cut­ed a $270 mil­lion deal to buy out The Med­i­cines Com­pa­ny’s in­fec­tious dis­ease unit — in­clud­ing ori­ta­vancin. In ad­di­tion to the SO­LO tri­als, the FDA based its lat­est ap­proval for ori­ta­vancin on an open-la­bel phar­ma­co­ki­net­ics study, which com­pared a one-hour Kimyr­sa treat­ment to a three-hour Or­bac­tiv treat­ment. “Sin­gle-dose, long-act­ing an­tibi­otics, such as KIMYR­SA, may be es­pe­cial­ly ben­e­fi­cial for pa­tients who lack the sup­port or re­sources to ad­here to mul­ti­ple in­tra­venous ad­min­is­tra­tions,” An­drew Dold, an in­fec­tious dis­ease doc­tor in the Greater At­lanta re­gion, said in a state­ment. AUTHOR Jason Mast Editor Joan Butterton was sitting 30,000 feet above the Atlantic, flying to a conference in Europe, when the Merck scientist seated next to her started gushing about the HIV molecule the big pharma had just licensed from a small Japanese company. It was so potent in monkeys, the scientist said, that they couldn’t figure out what the lowest effective dose was and it stayed in the animals for an incredibly long time, far longer than the approved drugs HIV patients took daily. Keep reading Endpoints with a free subscription Unlock this story instantly and join 103,700+ biopharma pros reading Endpoints daily — and it's free. SIGN UP John Carroll Editor & Founder Back in the spring of 2014, Versant put together a tidy $25 million launch round for a small upstart with big dreams called CRISPR Therapeutics. They had an impressive brain trust, headed by CRISPR/Cas9 innovator — and now Nobel winner — Emmanuelle Charpentier. And that exclusive band of gene editing pioneers included Matt Porteus out of Stanford. CRISPR Therapeutics, of course, went on to become a leader in the gene editing field, now partnered with Vertex on a cutting-edge program for sickle cell disease. The biotech has a market cap brushing up against $10 billion — serious money in an era that’s turned its attention to biotech and the future of medicine. Premium subscription required Kyle Blankenship Managing Editor Despite immense clinical promise, small cell and gene therapy players have faced a chronic manufacturing bottleneck tied to limited cash and specialized expertise. Born from the idea of disrupting the manufacturing business model in that space, ElevateBio has scored its biggest fundraising round yet to clear the logjam. ElevateBio closed a massive $525 million Series C it will use to keep building its next-gen startup engine and one-stop-shop cell and gene therapy manufacturing “ecosystem,” the biotech said Monday. Keep reading Endpoints with a free subscription Unlock this story instantly and join 103,700+ biopharma pros reading Endpoints daily — and it's free. SIGN UP Associate Editor Galecto $GLTO is yanking the top dose of its IPF drug GB0139 in a clinical study after the safety monitoring board flagged an imbalance of adverse events in the study pointing to the therapy. Galecto expects to continue recruiting patients who are not taking nintedanib or pirfenidone at screening and who would be randomized to receive GB0139 3 mg or placebo. The DSMB recommended the patients randomized to the 10mg group and all those taking nintedanib or pirfenidone should be discontinued from the study. Based on these recommendations, the Company plans to work with both the study investigators and the appropriate regulatory authorities to implement these changes promptly. Read More