Covid-19 roundup: Sh­iono­gi’s an­tivi­ral pill hits the mark; Ocu­gen strikes deal for in­tranasal vac­cine

Japan­ese phar­ma Sh­iono­gi’s Covid-19 an­tivi­ral against Omi­cron passed its Phase III tri­al in Asia, meet­ing its pri­ma­ry end­point.

The drug, a pro­tease in­hibitor known as en­sitrelvir, was ad­min­is­tered dai­ly for five days and led to a sig­nif­i­cant re­duc­tion in symp­toms such as stuffy or run­ny nose, sore throat, cough, feel­ing hot or fever­ish, and low en­er­gy or tired­ness with­in 72 hours of its on­set, the com­pa­ny an­nounced Wednes­day. A to­tal of 1,821 most­ly vac­ci­nat­ed pa­tients from Japan, South Ko­rea and Viet­nam were en­rolled in the study.

The me­di­an time for pa­tients to ex­pe­ri­ence re­lief in five Covid-19 symp­toms was sig­nif­i­cant­ly re­duced in the co­hort that was treat­ed with the low dose of en­sitrelvir (the dose lev­el sub­mit­ted for ap­proval in Japan) com­pared to place­bo: 167.9 hours ver­sus 192.2. No sig­nif­i­cant ad­verse ef­fects were not­ed, the com­pa­ny said.

Mean­while, the study al­so hit its sec­ondary end­point — re­duc­tion in vi­ral RNA on day 4 — fol­low­ing the third dose.

The com­pa­ny has sub­mit­ted the topline re­sults of the Phase III tri­al to Japan­ese drug reg­u­la­tors for re­view. Pre­vi­ous­ly, the reg­u­la­to­ry au­thor­i­ties in Japan de­nied emer­gency ap­proval for use of the pill, and asked for more da­ta on its ef­fec­tive­ness, Reuters re­port­ed.

If ap­proved, Sh­iono­gi’s drug could face stiff com­pe­ti­tion with Covid-19 pills from Pfiz­er and Mer­ck’s Covid-19 an­tivi­rals that have al­ready been ap­proved in Japan and in oth­er coun­tries.

Ocu­gen en­ters a deal to com­mer­cial­ize a ‘uni­ver­sal’ in­tranasal covid vac­cine

Penn­syl­va­nia-based Ocu­gen wants to com­mer­cial­ize an in­tranasal­ly de­liv­ered Covid-19 vac­cine in the US, Eu­rope, and Japan.

The com­pa­ny has en­tered a li­cens­ing deal with Wash­ing­ton Uni­ver­si­ty in St. Louis, which de­vel­oped the vac­cine along with In­di­an phar­ma­ceu­ti­cal Bharat Biotech. Ocu­gen claims that the in­tranasal shot could be ef­fec­tive against all vari­ants of Covid-19. This vac­cine is al­ready au­tho­rized for emer­gency use in In­dia, the com­pa­ny said.

“As the ef­fort to end the pan­dem­ic fo­cus­es on ef­fec­tive boost­er op­tions, Ocu­gen is ex­cit­ed about the po­ten­tial for this vac­cine to be a uni­ver­sal boost­er, re­gard­less of pre­vi­ous COVID-19 vac­ci­na­tion his­to­ry,” the com­pa­ny added in a press re­lease.

The vac­cine con­tains spike pro­tein of the SARS-CoV-2 virus, pack­aged in an ade­n­ovirus vec­tor.

Ac­cord­ing to the com­pa­ny, de­liv­er­ing the vac­cine through the nasal route cre­ates strong im­mu­ni­ty against the virus in the nose, mouth, up­per air­ways and lungs, where the virus tends to in­fect the most.

“Be­cause the vac­cine can be de­liv­ered di­rect­ly in­to the nose, it is specif­i­cal­ly de­signed to block in­fec­tion at the por­tal of virus en­try, and we be­lieve it may help pre­vent trans­mis­sion as well as pro­vide pro­tec­tion against new COVID-19 vari­ants,” said Michael Di­a­mond, in­ven­tor of the nasal vac­cine tech­nol­o­gy.

Re­vive’s Covid pill finds a stop sign at the FDA’s doorsteps

Re­vive Ther­a­peu­tics has hit a hilly road with its oral Covid-19 drug.

The FDA has re­ject­ed the pri­ma­ry end­point for the Phase III study of the com­pa­ny’s an­tivi­ral drug bu­cil­lamine. Re­vive is cur­rent­ly study­ing the drug’s an­ti-in­flam­ma­to­ry and an­tivi­ral prop­er­ties in pa­tients with mild to mod­er­ate Covid-19.

Reg­u­la­tors, how­ev­er, have asked the com­pa­ny to sub­mit a meet­ing re­quest to dis­cuss the “ap­pro­pri­ate end­points and jus­ti­fi­ca­tion of the rel­e­vance of the re­vised pri­ma­ry end­point,” the com­pa­ny said in a press re­lease.

Mean­while, the com­pa­ny has de­cid­ed to con­tin­ue with and re­view post-dose se­lec­tion da­ta in around 500 pa­tients.

“Re­gard­less of the out­come, the Com­pa­ny would pro­ceed to seek a meet­ing with the FDA to agree on a pro­posed plan for po­ten­tial reg­u­la­to­ry ap­proval,” Re­vive said in a press state­ment.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Senate health committee chair Bernie Sanders (D-VT) and Moderna CEO Stéphane Bancel (Tom Williams/CQ Roll Call via AP Images)

Mod­er­na CEO de­fends Covid-19 vac­cine price change at Sen­ate com­mit­tee grilling

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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