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 EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.