Fred­er­ick Bed­ding­field left Si­en­na Bio­phar­ma­ceu­ti­cals last De­cem­ber, a few months af­ter the strug­gling biotech filed for bank­rupt­cy. The for­mer CEO was plan­ning to take some time off, un­til he re­ceived a call from the Uni­ver­si­ty of Penn­syl­va­nia pro­fes­sor Wen­chao Song.

Song was look­ing for some­one to helm Ki­ra Phar­ma­ceu­ti­cals, a start­up he co-found­ed to de­vel­op a “new gen­er­a­tion” of com­ple­ment-tar­get­ed ther­a­pies for im­mune-me­di­at­ed dis­eases. The two got talk­ing, one thing led to an­oth­er, and “it just turned out to be a great fit,” Bed­ding­field said.

On Thurs­day, Ki­ra emerged from stealth mode with Bed­ding­field as CEO, $46 mil­lion from the ven­ture well, and a lead can­di­date ex­pect­ed to hit the clin­ic in the next three months.

“It’s the tip of the ice­berg for com­ple­ment dis­eases,” Bed­ding­field said.

While the com­pa­ny is in­ter­est­ed in im­prov­ing on the stan­dard of care for some dis­eases, “our big­ger goal is to treat dis­eases where there’s re­al­ly … a com­plete­ly un­met need, and there are no com­ple­ment drugs ap­proved,” he said.

The com­ple­ment cas­cade, a part of the in­nate im­mune sys­tem, is “great when it’s work­ing well,” Bed­ding­field said. But dys­reg­u­la­tion can lead to au­toim­mune dis­or­ders. De­pend­ing on that dys­reg­u­la­tion, block­ing cer­tain parts of the path­ways that ac­ti­vate the com­ple­ment sys­tem can be “quite ef­fec­tive” in con­trol­ling dis­ease, the CEO said.

“Some­times pa­tients have a ge­net­ic pre­dis­po­si­tion, some mu­ta­tion in … part of this com­ple­ment cas­cade that makes them have this ab­nor­mal re­sponse. Oth­er times, we don’t know ex­act­ly why it’s ex­ag­ger­at­ed, but it is. And in­ter­est­ing­ly, if you look at Covid pa­tients, many of them have (an) ex­ag­ger­at­ed com­ple­ment cas­cade re­sponse,” he said.

Ki­ra’s lead can­di­date, P014, is de­signed to in­hib­it both up­stream and down­stream com­ple­ment tar­gets. It’s en­gi­neered with an ex­tend­ed half-life and po­ten­cy, and has the po­ten­tial to be self-ad­min­is­tered at home. While Ki­ra has yet to an­nounce which in­di­ca­tions it’s go­ing af­ter, Bed­ding­field said the can­di­date should en­ter the clin­ic with­in the next three months. The pipeline al­so in­cludes two oth­er can­di­dates in IND-en­abling stages.

Cam­bridge, MA-based Ki­ra was found­ed in 2017. While in stealth, it bagged an $18 mil­lion Se­ries A and $28 mil­lion Se­ries B from a slate of in­vestors in­clud­ing Quan Cap­i­tal, 6 Di­men­sions Cap­i­tal, Qim­ing Ven­ture Part­ners, and Sinopharm Cap­i­tal. While its head­quar­ters is in the US, the com­pa­ny al­so boasts a Suzhou, Chi­na of­fice.

“I think we’re the on­ly com­ple­ment com­pa­ny that from the get-go has a cross-bor­der strat­e­gy to bring ther­a­pies … glob­al­ly to the US to Chi­na,” Bed­ding­field said. This will al­low the com­pa­ny to eas­i­ly con­duct clin­i­cal tri­als in both coun­tries.

Even so, the biotech may have some catch­ing up to do. Alex­ion, which made waves with the in­tro­duc­tion of its first an­ti-C5 an­ti­body, snagged its sec­ond ap­proval for the com­ple­ment ther­a­py Ul­tomiris last year. The drug, which blocks the C5 path­way, has the FDA’s OK to treat atyp­i­cal he­molyt­ic ure­mic syn­drome and parox­ys­mal noc­tur­nal he­mo­glo­bin­uria. It raked in $338.9 mil­lion in net sales last year.

Last Au­gust, Alex­ion was hit with a sur­prise in­ter partes re­view. The US Patent Tri­als Ap­peal Board ac­tion was stoked by Am­gen, which pushed to over­turn patents on the com­ple­ment in­hibitor Soliris to cre­ate a biosim­i­lar.

While Bed­ding­field once served as CMO of both Kythera and Al­ler­gan, his lat­est gig was at Si­en­na, which filed for a Chap­ter 11 last Sep­tem­ber. The biotech’s stock nev­er quite re­cov­ered from the fail­ure of its ex­per­i­men­tal ac­ne drug SNA-001, which flopped in two sep­a­rate tri­als test­ing its ef­fi­ca­cy when man­aged by laser tech. The com­pa­ny cut 20 jobs in a re­struc­tur­ing to re­fo­cus on pso­ri­a­sis and as­so­ci­at­ed pru­ri­tus, and 7 more in con­nec­tion with the bank­rupt­cy fil­ing.

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.