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

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.