Por­to­la may not have had much suc­cess prov­ing the com­mer­cial val­ue of an an­ti-an­ti­co­ag­u­lant, but that’s not stop­ping Eu­ro­pean in­vestors from pour­ing $36.2 mil­lion (€32 mil­lion) in­to what they see as a su­pe­ri­or ap­proach put forth by a Dutch biotech.

Var­mX’s blood thin­ner re­ver­sal agent stems from re­search done by founder and CSO Pieter Re­its­ma at Lei­den Uni­ver­si­ty Med­ical Cen­ter. A mod­i­fied re­com­bi­nant form of fac­tor X, VMX-C001 “has an in­ser­tion of 16 amino acids that re­places a stretch of 7 amino acids in the so-called ser­ine pro­tease do­main” com­pared to the na­tive co­ag­u­la­tion fac­tor, CEO Alexan­der Vos told End­points News.

“This in­ser­tion leaves suf­fi­cient clot­ting ac­tiv­i­ty, whilst in­tro­duc­ing vir­tu­al­ly com­plete in­sen­si­tiv­i­ty to fac­tor Xa DOACS,” he added, re­fer­ring to oral fac­tor Xa in­hibitors.

Un­like Por­to­la’s An­dexxa — which is on­ly ap­proved to quick­ly dis­arm Eliquis and Xarel­to — Var­mX’s drug promis­es to counter the ef­fect of any DOAC. The biotech said it’s al­so eas­i­er to ad­min­is­ter and doesn’t lead to pro-throm­bot­ic risk.

Re­ports sug­gest that 2% to 3% of the 10 mil­lion pa­tients tak­ing FXa DOACs ex­pe­ri­ence spon­ta­neous se­vere bleed­ing, Vos said, which could be life-threat­en­ing. And there are al­ways pa­tients on an­ti­co­ag­u­lants who need to re­store some blood clot­ting func­tions for an emer­gency surgery.

The Se­ries B is de­signed to put the drug through clin­i­cal proof-of-con­cept, all the way up to the thresh­old of reg­is­tra­tional stud­ies for both se­vere bleed­ing and emer­gency surgery.

At that point — and there’s no guar­an­tee they will get there — Var­mX will find it­self fac­ing off with Alex­ion, which bagged Por­to­la and An­dexxa in a $1.4 bil­lion buy­out in May. The ac­qui­si­tion val­ued Por­to­la at $18 per share, a frac­tion of where it was at peak.

“The da­ta gen­er­at­ed so far sug­gests that VMX-C001 can be­come a dif­fer­en­ti­at­ed treat­ment so­lu­tion in an ever grow­ing mar­ket,” Guillem La­por­ta, whose Ys­ios Cap­i­tal co-led the fi­nanc­ing with INKEF Cap­i­tal, said in a state­ment.

Lund­beck­fonden Ven­tures joined the round, to­geth­er with ex­ist­ing in­vestors Bio­Gen­er­a­tion Ven­tures and In­no­va­tion­Quar­ter.

In ad­di­tion to the lead pro­gram, the lean team of 5 at Var­mX is de­vel­op­ing re­ver­sal agents for fu­ture class­es of an­ti­co­ag­u­lants, such as those tar­get­ing fac­tor XI(a).

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.