Pathalys Phar­ma, a pri­vate biotech co-found­ed by Japan­ese VC Catalys Pa­cif­ic and DaVi­ta Ven­ture Group in late 2020 to fo­cus on chron­ic kid­ney dis­ease, an­nounced Wednes­day morn­ing it reached a deal with Launch Ther­a­peu­tics to ad­vance two Phase III tri­als for a drug de­signed to treat a parathy­roid con­di­tion for he­modial­y­sis pa­tients. The drug is called upaci­cal­cet, al­so known as PLS240.

As part of the deal, Pathalys al­so raised $150 mil­lion in se­cured prod­uct fi­nanc­ing and eq­ui­ty to push upaci­cal­cet through Phase III and to sup­port a po­ten­tial launch if it’s ap­proved. Abing­worth led the round, while Car­lyle and Or­biMed joined in, as did Catalys Pa­cif­ic and DaVi­ta Ven­ture Group.

In re­turn for the in­vest­ment, Pathalys re­tains world­wide com­mer­cial rights to upaci­cal­cet out­side Japan and Asia. The prod­uct fi­nanc­ing fund­ing gets paid back out of rev­enues of the drug.

The drug, so far Pathalys’ on­ly drug in its pipeline, is a cal­cimimet­ic — a type of drug that mim­ics the ac­tion of cal­ci­um on tis­sues. Oth­er cal­cimimet­ics al­ready ap­proved in the US come from Big Phar­ma Am­gen, with its brand drugs Sen­si­par and Parsabiv in­di­cat­ed to treat hy­per­parathy­roidism.

Pathalys’ drug was ap­proved as Up­a­sita in Japan back in 2021 for sec­ondary hy­per­parathy­roidism in dial­y­sis pa­tients — the same con­di­tion it’s shoot­ing for in the US. The drug was de­vel­oped by EA Phar­ma, which kicked off in 2016 as a gas­troin­testi­nal dis­ease biotech formed by Ei­sai Group and Aji­nomo­to Group.

Pathalys got the li­cense to de­vel­op the drug in US and Eu­rope in 2021, CEO Neal Fowler told End­points News.

Launch Ther­a­peu­tics, which kicked off in 2022, is es­sen­tial­ly the drug de­vel­op­ment arm of Car­lyle and its-now life sci­ence sub­sidiary Abing­worth. Fowler said that while the com­pa­ny was in dis­cus­sions with in­vestors to find cap­i­tal for Phase III tri­als, Pathalys be­came fa­mil­iar with Launch af­ter start­ing dis­cus­sions with Abing­worth.

Car­lyle, the pri­vate eq­ui­ty gi­ant, leapt in­to the biotech in­vest­ment scene last year when it bought out Abing­worth. At the time of the deal, Abing­worth and Car­lyle brought Launch Ther­a­peu­tics in­to the fold — which takes on clin­i­cal tri­al risk in ex­change for a share of the prof­its.

Launch Ther­a­peu­tics will have the lead role in ex­e­cut­ing and man­ag­ing the clin­i­cal tri­als, while Pathalys will be re­spon­si­ble for man­u­fac­tur­ing, com­mer­cial­iza­tion and work­ing with the FDA. The two iden­ti­cal tri­als, ex­pect­ed to launch in the first half of this year, will en­roll 375 pa­tients each and last for 20 months. Fowler said by that time­line, da­ta will read out in ear­ly 2025.

Fowler said that while the com­pa­ny is ex­cit­ed to get its first clin­i­cal tri­al un­der­way, Pathalys has big­ger am­bi­tions — and wants to ex­pand in­to mul­ti­ple as­sets in chron­ic kid­ney dis­ease.

“It’s just the be­gin­ning, and we’re ea­ger to get mov­ing,” Fowler added.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.