A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Re­my Luthringer Min­er­va

A to­tal of 365 pa­tients with no oth­er psy­chi­atric con­di­tions were en­rolled in the study and ran­dom­ized in­to five groups: three dif­fer­ent dos­es of sel­torex­ant, place­bo, and Am­bi­en. Un­like the house­hold drug, which pro­motes sleep by ac­ti­vat­ing the GA­BA neu­ro­trans­mit­ter, Min­er­va’s drug is “de­signed to mim­ic the nat­ur­al sleep process by in­hibit­ing the brain mech­a­nisms that pro­mote ex­ces­sive wake­ful­ness,” CEO Re­my Luthringer said in a state­ment.

The drug scored a clear win in im­prov­ing la­ten­cy to per­sis­tent sleep (LPS) com­pared to place­bo, as re­searchers tracked es­ca­lat­ing least squares mean on changes from base­line on Night 1: 16.4 min­utes (5 mg), 32.2 min­utes (10 mg) and 36.6 min­utes (20 mg), with p ≤0.001 on the two high­er dos­es. “Ad­van­tages over place­bo were al­so ob­served at Night 13: 5.2 min­utes for the 5 mg, 28.6 min­utes for the 10 mg (p ≤0.001), and 21.0 min­utes for the 20 mg (p ≤0.001),” the com­pa­ny added.

But per­haps more in­ter­est­ing were the sec­ondary analy­sis in which sel­torex­ant seems to work bet­ter than Am­bi­en in terms of LPS as well as WA­SO-6, a mea­sure­ment of dis­turbed sleep through­out the night. That was true on Night 13 on both scores, no­table be­cause Am­bi­en did not show su­pe­ri­or­i­ty over place­bo on the same night, like­ly due to a known, wan­ing ef­fect of the stan­dard-of-care drug.

Min­er­va had much less to say about safe­ty — a big deal on sleep drugs — oth­er than that it’s well tol­er­at­ed, with treat­ment-emer­gent ad­verse events (TEAEs) tak­ing place in 33.8% of pa­tients across the three drug arms com­pared to 49.3% in place­bo group and 42.5% in the Am­bi­en co­hort. The FDA sets a high bar on safe­ty for sleep drugs, cre­at­ing a chal­lenge that has kept most small play­ers out of a dif­fi­cult field. Mar­ket­ing is al­so a big chal­lenge, even for the ma­jor bio­phar­mas.

The sub­se­quent surge on share price $NERV — up 51.93% and reach­ing $6.43 — helped Min­er­va re­cov­er some lost grounds from the con­tro­ver­sial read­out in May. At one point pre-mar­ket trad­ing brought the stock over $7 but the en­thu­si­asm has sub­sided as in­vestors pon­der on the mar­ket­ing chal­lenges ly­ing ahead.

That tri­al saw a de­crease in the Mont­gomery-As­berg De­pres­sion Rat­ing Scale among the 20 mg group, where pa­tients were treat­ed with the oral pill along­side stan­dard an­ti­de­pres­sant ther­a­pies.

Ven­tur­ing in­to a field most biotechs have steered clear of, Min­er­va’s over­all propo­si­tion with sel­torex­ant is to treat in­som­nia and re­lat­ed mood dis­or­ders by tin­ker­ing with the orex­in sys­tem, which is as­so­ci­at­ed with feed­ing, home­osta­sis, arousal, mod­u­la­tion of sleep-wake cy­cles and mo­ti­va­tion. J&J signed on as a part­ner to the ORX2 in­hibitor on two in­di­ca­tions in 2014, but re­turned the rights for in­som­nia three years lat­er.

Pa­tients with de­pres­sion who al­so strug­gle to sleep — around 105 to­tal be­tween the drug and place­bo arms — showed a big­ger im­prove­ment in the MADRS than the over­all tri­al pop­u­la­tion, the com­pa­ny had re­port­ed.

So­cial im­age: Shut­ter­stock

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Ocular Therapeutix $OCUL has had its ups and downs in the 7 years since it went public. Friday was one of those down days.

The Bedford, MA-based biotech reported that its lead experimental eye drug, OTX-CSI (cyclosporine intracanalicular insert), failed a Phase II trial for dry eye disease. And the stock experienced one of its periodic meltdowns, dropping more than 30% ahead of the bell.

The therapy flat failed the primary endpoint: increased tear production at 12 weeks as measured by the Schirmer’s Test compared to the vehicle control group. And while investigators called out an improvement from baseline in “signs of dry eye disease as measured by total corneal fluorescein staining (CFS) and symptoms of dry eye disease as measured by the visual analogue scale (VAS) eye dryness in subjects treated with the OTX-CSI insert,” it wasn’t statistically significant.

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Sanofi and Regeneron can boast of another inflammatory disease where Dupixent has proven effective.

The best-selling drug, which targets both IL-4 and IL-13, has delivered a clean sweep in a Phase III trial for prurigo nodularis, a chronic disease characterized by itch so intense that it can affect patients’ sleep and psychology. Thick skin lesions can cover most of the body.

On the primary endpoint, 37% of patients taking Dupixent saw a clinically meaningful reduction in itch compared to 22% of those on placebo (p=0.0216) at week 12. All secondary endpoints were also met, including clearance of skin lesions and improvement in quality of life.