Fol­low­ing a suc­cess­ful Phase III study in April show­cas­ing the safe­ty and po­ten­tial of its new sleep drug, Idor­sia post­ed some mixed news in the sec­ond Phase III study, but that won’t stop a planned fil­ing aimed at reg­u­la­to­ry ap­proval.

The drug, a dual orex­in re­cep­tor an­tag­o­nist (DO­RA) called dari­dorex­ant, was found to sig­nif­i­cant­ly im­prove sleep main­te­nance and sub­jec­tive to­tal sleep time in 25 mg dos­es, repli­cat­ing re­sults from the first Phase III study. How­ev­er, im­prove­ments in sleep on­set and day­time func­tion­ing nar­row­ly missed sta­tis­ti­cal sig­nif­i­cance, de­spite nu­mer­i­cal con­sis­ten­cy with the April study.

Idor­sia al­so test­ed 10 mg dos­es of dari­dorex­ant in the study and found pos­i­tive re­sponse across all four ef­fi­ca­cy mea­sures, but all fell short of be­ing sta­tis­ti­cal­ly sig­nif­i­cant.

The new study mea­sured dari­dorex­ant’s ef­fects in 924 adult and el­der­ly pa­tients. Side ef­fects from the tests re­mained low, as with the first study, with se­ri­ous in­stances re­main­ing bal­anced across dosage amounts and place­bos, ac­cord­ing to the biotech.

Re­sults from the two stud­ies re­gard­ing the 25 mg dos­es and place­bos will now be pooled, and some an­a­lysts ex­pect this will of­fer a promis­ing pro­file to take to reg­u­la­tors. Ques­tions will like­ly re­main, how­ev­er, giv­en the cau­tion that reg­u­la­tors usu­al­ly take when ap­prov­ing in­som­nia treat­ments.

Pe­ter Welford at Jef­feries sees the poor re­sults for the low dose as a good thing, as it re­moves any temp­ta­tion the FDA may have to for­go the high dose and go with the less threat­en­ing low­er dose — as they did with Mer­ck. But its suc­cess is still no sure thing.

Im­por­tant­ly the low­er 10mg dose showed small­er non-sig­nif­i­cant ben­e­fits, re­mov­ing the risk reg­u­la­tors en­dorse a sub­op­ti­mal dose to err on the side of cau­tion, in our view. Com­mer­cial un­cer­tain­ties re­main.

In­som­nia drugs gen­er­al­ly are slow to be­come avail­able and are dif­fi­cult to pro­duce. The drugs are al­so heav­i­ly reg­u­lat­ed, as the FDA demon­strat­ed when it im­posed black box warn­ings last year on a slew of more com­mon­ly-known drugs like Lunes­ta, Am­bi­en and Sonata.

Where DO­RAs dif­fer from tra­di­tion­al in­som­nia drugs is in the in­hi­bi­tion of orex­in sig­nal­ing. Orex­ins, dis­cov­ered in 1998, are hor­mones pro­duced by the hy­po­thal­a­mus that reg­u­late sleep, arousal and ap­petite.

On­ly two DO­RAs have hit the mar­ket in the US, but they al­so faced up­hill climbs. Mer­ck’s Bel­som­ra (chem­i­cal­ly known as su­vorex­ant), re­leased in 2014, re­quired warn­ing la­bels re­gard­ing next-day resid­ual ef­fects and abuse po­ten­tial, among oth­er safe­ty risks.

Ad­di­tion­al­ly, Ei­sai’s DO­RA Dayvi­go (lem­borex­ant) scored an FDA ap­proval in De­cem­ber and launched last month but al­so need­ed sim­i­lar warn­ings.

Idor­sia spun off of Swiss phar­ma com­pa­ny Acte­lion af­ter a $30 bil­lion ac­qui­si­tion by John­son & John­son in ear­ly 2017. Idor­sia had been Acte­lion’s old re­search and de­vel­op­ment de­part­ment and is head­ed up by Acte­lion’s founder and CEO, Jean-Paul Clozel. Dari­dorex­ant is one of four de­vel­op­men­tal drugs cur­rent­ly in Idor­sia’s pipeline that has reached the Phase III stage.

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.