Linaprazan didn’t make much of a mark at As­traZeneca. De­spite show­ing promise in ear­ly-stage stud­ies, the potas­si­um com­pet­i­tive acid block­er, or PCA-B, failed to beat Nex­i­um, the phar­ma gi­ant’s block­buster pro­ton pump in­hibitor in treat­ing acid re­flux. The drug was then un­cer­e­mo­ni­ous­ly purged from the pipeline.

Kjell An­der­s­son

As the pre­clin­i­cal project leader in Möl­ndal, Swe­den, Kjell An­der­s­son wit­nessed the rise and fall of linaprazan. Hav­ing helped de­vel­op Nex­i­um, he al­so knew that about 40% of pa­tients still suf­fer from symp­toms, in­clud­ing heart­burn and chest pain, even if they’re on treat­ment. So to­geth­er with col­leagues Mikael Dahlström and Pe­ter Unge, he pur­chased rights to pro­drugs of linaprazan and launched his own start­up.

Cin­clus Phar­ma is now 6 years old and has just land­ed $26 mil­lion (SEK 250 mil­lion) to fund a Phase II tri­al of its lead drug, X842.

The rea­son why linaprazan didn’t work was that it was elim­i­nat­ed too quick­ly from the body, so goes the com­pa­ny’s the­o­ry, and the du­ra­tion of acid block­ing was thus too short. They point to Take­da’s vono­prazan, a fel­low PAC-B drug, and its ap­proval in Japan to high­light the po­ten­tial of the ap­proach.

Pe­ter Unge

Out­side of Japan, vono­prazan is now in the hands of Phath­om Phar­ma, the Take­da/Fra­zier spin­out ded­i­cat­ed to GI dis­eases.

With the help of Fourth Swedish Na­tion­al Pen­sion Fund as well as ex­ist­ing share­hold­ers in­clud­ing Bengt Ju­lan­der, Jonas Sjö­gren and Re­ci­pharm Ven­ture Fund, Cin­clus ex­pects to start a Phase II in gas­troe­sophageal re­flux dis­ease (GERD) lat­er this year.

“The in­tro­duc­tion of Losec and oth­er pro­ton pump in­hibitors in the 1980s and the 1990s was a ma­jor step for­ward in the treat­ment of GERD,” CEO An­der­s­son said in a state­ment, re­fer­ring to an­oth­er drug he was in­volved in steer­ing. “How­ev­er, there is po­ten­tial to help sig­nif­i­cant­ly more pa­tients to a bet­ter life by de­vel­op­ing even more ef­fi­cient drugs.”

As­traZeneca, mean­while, has moved on from the lega­cy field, sell­ing Losec and Nex­i­um off to a pair of Ger­man drug­mak­ers.

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.