The process is grind­ing and of­ten ter­mi­nal, like a fine car with a trans­mis­sion patched up a dozen times but still jam­ming and in dire need of re­place­ment. Pa­tients with late-stage chron­ic liv­er dis­ease will de­com­pen­sate (lose or­gan func­tion) and though that in­stance can be treat­ed, each time is like an­oth­er jolt on the gears. Even­tu­al­ly, the car won’t dri­ve. There are trans­plants, but over half of the pa­tients die wait­ing for those.

Meri­am Kab­baj

A new method from Swiss biotech Ver­san­tis wouldn’t cure chron­ic liv­er dis­ease but it promis­es to give far bet­ter im­me­di­ate care and of­fer a treat­ment for a cou­ple rare forms of liv­er dis­ease that cur­rent­ly leave pa­tients with­out good op­tions short of a trans­plant. The com­pa­ny just took in $16 mil­lion in Se­ries B fund­ing to put its plat­form through first-in-hu­man and ef­fi­ca­cy tri­als in small sub­sets of a dis­ease that kills around 2 mil­lion world­wide very year.

“This is a very dis­rup­tive tech­nol­o­gy,” Ver­san­tis co-founder and COO Meri­am Kab­baj told End­points News. “Liv­er dis­ease is on­ly grow­ing and cause many deaths year af­ter year and so far there haven’t been any ef­fi­cient treat­ments.”

Vince Forster

Ver­san­tis’s plat­form works by tak­ing a pop­u­lar and well-re­searched drug de­liv­ery method called li­po­somes and turn­ing it on its head, to cre­ate what CEO Vince Forster called an “un­de­liv­ery mech­a­nism”: Rather than de­liv­er­ing drugs, it takes out tox­ins. Two liters of liq­uid filled with “mi­croscav­engers” — their VS-01 drug — would be ad­min­is­tered in­to a pa­tient’s bel­ly. The scav­engers would swoop up am­mo­nia and oth­er tox­ins the liv­er can no longer me­tab­o­lize, and then the so­lu­tion is sim­ply tak­en out.

“What we can pro­vide is the same ef­fi­cien­cy as dial­y­sis,” Kab­baj said, “but the main dif­fer­ence is that it’s much safer and it can be im­ple­ment­ed very ear­ly on.”

Al­though liv­er dis­ease is one of the most com­mon in the de­vel­oped world, Ver­san­tis cur­rent­ly fo­cus­es on niche ar­eas with­in it: de­com­pen­sat­ed liv­er cir­rho­sis that has caused a form of di­min­ished brain func­tion called he­pat­ic en­cephalopa­thy and acute-on-chron­ic liv­er fail­ure, the more se­vere dis­ease for which they’ve re­ceived FDA or­phan drug sta­tus in 2017. A Phase I tri­al they say promis­es some ef­fi­ca­cy da­ta is just un­der­way and the Se­ries B mon­ey will fund a Phase IIa tri­al.

Ver­san­tis is not the on­ly com­pa­ny get­ting in­to the rapid­ly grow­ing liv­er game. An­oth­er young Swiss biotech, Alen­tis, got near­ly as much in March for their Se­ries A fund­ing while Bel­gium’s Promethera Bio­sciences col­lect­ed $44 mil­lion in May for end-stage liv­er dis­ease, among oth­ers. The area can be a mine­field, though. Last year, Vi­tal Ther­a­pies saw its stock fall 88% to $0.70 af­ter its plat­form to treat acute liv­er dis­ease bombed a Phase III tri­al.

But Kab­baj ar­gued that Ver­san­tis had an edge be­cause un­like oth­er treat­ments, its mi­croscav­engers re­move not just am­mo­nia but oth­er tox­ic metabo­lites. And it’s not on­ly the liv­er. Oth­er parts of the body, in­clud­ing the brain and kid­neys, which al­so see tox­ic buildup from liv­er dis­ease, ben­e­fit as well.

Ver­san­tis is al­so look­ing at broad­er ap­pli­ca­tions for the drug, in­clud­ing for broad­er forms of liv­er dis­ease, for a con­di­tion in in­fants that caus­es po­ten­tial­ly fa­tal buildups in am­mo­nia and, fur­ther down, for treat­ing opi­od over­dos­es.

Swiss­canto In­vest by Zürcher Kan­ton­al­bank led the fi­nanc­ing , Es­per­ante Ven­tures and new pri­vate in­vestors. Redalpine HealthE­quity and Zürcher Kan­ton­al­bank Start-up Fi­nance, both ex­ist­ing in­vestors,  al­so par­tic­i­pat­ed in this round.

So­cial im­age left to right: Vince Forster, So­phie Biguenet, Rekha John­son, Meri­am Kab­baj (Ver­san­tis)

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.