Glax­o­SmithK­line’s Benlysta isn’t alone in the small cir­cle of ap­proved lu­pus nephri­tis drugs any­more.

Lit­tle Au­rinia Phar­ma­ceu­ti­cals has got­ten the green light from the FDA to start mar­ket­ing its first and on­ly pro­gram, vo­closporin, un­der the brand name Lup­ky­nis — some­thing CEO Pe­ter Green­leaf says it’s been ready to do since De­cem­ber.

Reg­u­la­tors went right down to the wire on the de­ci­sion, keep­ing the com­pa­ny and the en­tire sales­force it’s al­ready as­sem­bled on its toes.

Pe­ter Green­leaf

But they haven’t been idle. In an ear­li­er in­ter­view, Green­leaf told End­points News that the field team, which to­tals about 100 to 150 sales reps, has al­ready start­ed talk­ing to physi­cians about LN and go­ing to med­ical meet­ings to present da­ta on vo­closporin. By block­ing cal­cineurin, a sig­nal­ing pro­tein in­volved in T cell ac­ti­va­tion, the small mol­e­cule oral drug is de­signed to in­hib­it IL-2 and tamps down in­flam­ma­tion in the kid­ney.

The Phase III tri­al, AU­RO­RA, vo­closporin plus my­cophe­no­late mofetil and low-dose cor­ti­cos­teroids hit the pri­ma­ry end­point on re­nal re­sponse at 1-year. It al­so hit the bar for get­ting pro­tein­uria, a mea­sure­ment of ac­tive dis­ease, un­der con­trol.

“I mean, that’s the num­ber 1 treat­ment goal that physi­cians search for,” Green­leaf said.

First an­nounced in late 2019, those re­sults were sev­en years in the mak­ing for CMO Neil Solomons, who was part of a team at Vi­for Phar­ma that brought in vo­closporin from Isotech­ni­ka — it was be­ing de­vel­oped for kid­ney trans­plant re­jec­tion at that time — and spun out Au­rinia. Even though a pre­vi­ous study he was in­volved in had ce­ment­ed my­cophe­no­late mofetil, or MMF, among oth­er un­ap­proved meds as the stan­dard of care, there was re­al­ly no di­rect ev­i­dence of their treat­ment ef­fect (They were al­so “high­ly tox­ic,” ac­cord­ing to a tri­al in­ves­ti­ga­tor.)

Neil Solomons

“We’re the first com­pa­ny to do that,” Solomons said, “ran­dom­ized blind­ed con­trolled study with our Phase II tri­al back in 2016 to ac­tu­al­ly demon­strate that the drug ac­tu­al­ly tru­ly works in this area.“

Al­so among the firsts: a patent­ed dos­ing pro­to­col that al­lows pa­tients to titrate down the dose based on an es­ti­mate of re­nal func­tion known as eGFR, and re­duc­tion of cor­ti­cos­teroids re­quired in the reg­i­men.

All of those qual­i­ties, the com­pa­ny reck­ons, could give its reps plen­ty to con­vince doc­tors to take on their drug.

Green­leaf added that vo­closporin “works very very rapid­ly,” show­ing ben­e­fit at both the 6-month and 1-year time points that seems com­pa­ra­ble to — with the usu­al caveats about cross-tri­al com­par­isons — what Benlysta, a bi­o­log­ic, showed at 2 years.

“Who knows what that means for fu­ture treat­ment — how they’re used along­side of each oth­er, in con­cert or with­in the full treat­ment con­tin­u­um,” the CEO, who’s run a trio of oth­er biotechs af­ter leav­ing As­traZeneca’s Med­Im­mune, said. “But to­day as it ex­ists we think our drug stands very well on its own.”

By their count, the LN pa­tient pop­u­la­tion in the US is well north of 100,000. With $400 mil­lion in cash, Au­rinia’s $AUPH com­mer­cial team will have am­ple fund­ing for sev­er­al years. Ot­su­ka, its new part­ner, is tasked with scor­ing OKs and com­mer­cial­iz­ing in the EU, Japan and else­where.

Joseph Schwartz of SVB Leerink is a be­liev­er. While GSK may have the up­per hand at launch, he wrote, vo­closporin should even­tu­al­ly “come out on top, as it has su­pe­ri­or ef­fi­ca­cy as com­pared to Benlysta”: Au­rinia re­port­ed a re­nal re­sponse rate of 40.8% ver­sus 22.5% in the con­trol arm while Benlysta’s dif­fer­ence with con­trol was small­er (43% vs 32%).

For 2021, he’s mod­el­ing US sales at $87.6 mil­lion as­sum­ing a price of $35,000.

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.