When Aard­vark Ther­a­peu­tics CEO Tien Lee start­ed his work on the biotech’s lead can­di­date, ap­petite sup­pres­sion was the goal for the small mol­e­cule.  Soon af­ter, his team start­ed to see added ben­e­fits with low­er blood glu­cose lev­els and an­ti-in­flam­ma­to­ry ac­tiv­i­ty. On the tail end of that, the com­pa­ny has emerged from stealth mode and an­nounced to­day that they’ve raised enough cash in the B round to cov­er mid-stage de­vel­op­ment work.

San Diego-based Aard­vark has se­cured $29 mil­lion in Se­ries B fi­nanc­ing. The mon­ey will be used to com­plete three Phase II tri­als of its lead com­pound ARD-101, a small mol­e­cule bit­ter taste re­cep­tor pan-ag­o­nist.  The funds will al­so be used to ad­vance ad­di­tion­al for­mu­la­tions for the can­di­date.

The fundrais­ing was led by Sor­ren­to Ther­a­peu­tics and fea­tured par­tic­i­pa­tion from Vick­ers Ven­ture Part­ners, Pre­mier Part­ners, BNH In­vest­ment, and Ko­rea Omega. The Foun­da­tion for Prad­er-Willi Re­search par­tic­i­pat­ed as well, which is key be­cause a Phase II tri­al in pa­tients with Prad­er-Willi Syn­drome is set to kick off lat­er this year. PWS is a ge­net­ic dis­or­der that leads pa­tients to be­come con­stant­ly hun­gry. That can of­ten lead to obe­si­ty and type 2 di­a­betes.

“I think we’re re­al­ly on to some­thing,” Lee said in a call with End­points News Wednes­day. “There are a few com­pa­nies that have looked in­to this space be­fore but no one has re­al­ly delved in and tried to ex­ploit this gut-brain path­way us­ing bit­ter taste re­cep­tors.”

ARD-101 has shown pos­i­tive ef­fects against obe­si­ty, hy­per­pha­gia, di­a­betes, hy­per­lipi­demia and in­flam­ma­tion in an­i­mal mod­els so far.

The drug uti­lizes bit­ter taste re­cep­tors, which Lee says are not on­ly in the mouth, but all over the body, and act as na­ture’s way of pro­tect­ing you against tox­ins. Over 99% of the drug is re­tained in the gut, which nor­mal­ly could be a bad thing for small mol­e­cules, but in this case, it ac­ti­vates en­teroen­docrine cells in the gut. When giv­en through an IV, the can­di­date doesn’t work the same, Lee said.

Aard­vark raised $10 mil­lion dur­ing its Se­ries A fundrais­ing two years ago, and that mon­ey was used to bring the can­di­date to in-hu­man tri­als. While the $29 mil­lion will more than cov­er the com­ple­tion of three Phase II tri­al, there is a lot more op­por­tu­ni­ty on the hori­zon, Lee said. The in­tent is to de­vel­op be­yond PWS in the long term, but for now it’s fo­cused on tak­ing a shot at an ac­cel­er­at­ed ap­proval for the ge­net­ic dis­ease — a goal that has elud­ed oth­ers.

“The main qual­i­ty of life im­pair­ment for Prad­er-Willi Syn­drome is an un­abat­ed ap­petite, says the CEO. “These kids, if giv­en un­re­strict­ed food ac­cess, they eat to the point of stom­ach rup­ture some­times. We have a lot of di­a­betes and obe­si­ty re­lat­ed com­pli­ca­tions in young adult­hood, and the fact that we’re hit­ting a va­ri­ety of hor­mones, we think we’re able to shut down ap­petite in a very unique way. We’ll see. Bi­ol­o­gy is hard and we’re not mak­ing any promis­es, but we’re def­i­nite­ly very hope­ful that we can see a dif­fer­ence for these kids.”

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.