Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

Af­ter a more than 15-year run, a Cal­i­for­nia-based biotech is ex­plor­ing op­tions, in­clud­ing a sale, af­ter its lead ex­per­i­men­tal ther­a­py failed an ex­plorato­ry mid-stage study in pa­tients with mid­dle ear in­fec­tions char­ac­ter­ized by a build-up of flu­id be­hind the eardrum.

The com­pa­ny, ini­tial­ly called Tokai Phar­ma­ceu­ti­cals but which sub­se­quent­ly changed its name to Novus Ther­a­peu­tics in 2017, saw its shares more than halve on Mon­day af­ter the drug — OP0201— did not pass muster as an ad­junct ther­a­py to oral an­tibi­otics in in­fants and chil­dren aged 6 to 24 months with acute oti­tis me­dia (OM).

Oti­tis me­dia is of­ten caused by a block­age in the pas­sage­way that con­nects the mid­dle ear to the back of the nasal cav­i­ty called the Eu­stachi­an tube. Com­prised of a sur­fac­tant (di­palmi­toylphos­phatidyl­choline) and a spread­ing agent (cho­les­teryl palmi­tate) sus­pend­ed in a pro­pel­lant, OP0201 is ad­min­is­tered in­tranasal­ly via a pres­sur­ized me­tered-dose in­haler to “de-stick” the tube re­store ven­ti­la­tion in the mid­dle ear.

In the tri­al, pa­tients were treat­ed twice dai­ly for 10 days and fol­lowed up to one month. There were two main goals: the res­o­lu­tion of bulging tym­pan­ic mem­brane and res­o­lu­tion of mid­dle ear ef­fu­sion.

Source: Novus Ther­a­peu­tics, 2020

Click on the im­age to see the full-sized ver­sion

So far, there have been no ther­a­pies ap­proved to specif­i­cal­ly treat OM. An­tibi­otics are used to ad­dress bac­te­r­i­al in­fec­tions that may arise as a re­sult of the con­di­tion, but they have no im­pact on vi­ral in­fec­tions. In or­der to deal with re­cur­rent or chron­ic oti­tis me­dia,  surgery is rec­om­mend­ed in which the tym­pan­ic mem­brane is per­fo­rat­ed to im­prove drainage and ven­ti­la­tion of the mid­dle ear.

Af­ter the failed study, Novus’ stock closed down about 52% at 62 cents.

Gre­go­ry Flesh­er

“We rec­og­nize that con­tin­ued de­vel­op­ment of our sur­fac­tant-based nasal aerosol will re­quire sig­nif­i­cant time and cap­i­tal,” said com­pa­ny chief Gre­go­ry Flesh­er in a state­ment. “We must fund the com­pa­ny for sev­er­al years in or­der to com­plete ad­di­tion­al for­mu­la­tion and de­vice de­vel­op­ment, ini­ti­ate the next oti­tis me­dia clin­i­cal tri­al, and ul­ti­mate­ly de­liv­er clin­i­cal da­ta. Giv­en our cur­rent val­u­a­tion rel­a­tive to our cap­i­tal needs, and giv­en the op­er­a­tional chal­lenges with the on­go­ing COVID-19 pan­dem­ic, we be­lieve that ex­plo­ration of all op­tions is the ap­pro­pri­ate course of ac­tion.”

In Jan­u­ary, the com­pa­ny said it had enough in the cof­fers to keep the lights on un­til the fourth quar­ter of 2020.

There is now a crowd­ed pipeline ad­dress­ing ail­ments of the ear, giv­en that most prod­ucts such as hear­ing aids and cochlear im­plants ad­dress ear dam­age caused by ge­net­ics, noise, ag­ing, or drugs, but noth­ing quite cures or in­deed tar­gets the bi­o­log­i­cal un­der­pin­nings of hear­ing loss. Vy­ing to fill that gap, a pletho­ra of de­vel­op­ers is work­ing on ther­a­peu­tics in a bur­geon­ing field.

Boston-based Ak­ou­os is work­ing on a ther­a­py de­signed to help in­di­vid­u­als with sen­sorineur­al hear­ing loss due to mu­ta­tions in the otofer­lin (OTOF) gene. Al­so in Boston is Deci­bel Ther­a­peu­tics, which is work­ing on re­gen­er­a­tion by tar­get­ing tiny hairs that grow in the in­ner ear to ad­dress con­gen­i­tal hear­ing loss or age-re­lat­ed bal­ance dis­or­ders. Fre­quen­cy Ther­a­peu­tics has a mid-stage hair cell re­gen­er­a­tion pro­gram us­ing prog­en­i­tor cells.

Across the At­lantic, UK-based Rin­ri Ther­a­peu­tics is work­ing on treat­ing hear­ing loss by trans­plant­i­ng ot­ic neur­al prog­en­i­tor cells in­to the in­ner ear. Am­s­ter­dam-based Au­dion Ther­a­peu­tics has a com­pound in-li­censed from Eli Lil­ly, which is de­signed to turn on a chem­i­cal switch to pro­duce new sen­so­ry hair cells from oth­er cells in the in­ner ear to im­prove hear­ing.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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