Cheap SS­RI drug proves suc­cess­ful in re­duc­ing Covid-re­lat­ed hos­pi­tal­iza­tion times in large tri­al

An­oth­er weapon against Covid-19 could be made more promi­nent as re­sults from a large, place­bo-con­trolled tri­al pub­lished in the Lancet on Wednes­day evening pro­vide com­pelling ev­i­dence that the cheap SS­RI flu­vox­am­ine may re­duce Covid-re­lat­ed hos­pi­tal­iza­tion times.

Of the 741 par­tic­i­pants who re­ceived flu­vox­am­ine in the tri­al in Brazil, 79, or 10.6%, re­quired an ex­tend­ed stay for more than six hours in an emer­gency set­ting or hos­pi­tal­iza­tion, com­pared to 119 out of the 756 (15.7%) par­tic­i­pants who re­ceived place­bo.

The cheap and read­i­ly avail­able se­lec­tive sero­tonin re­up­take in­hibitor, typ­i­cal­ly used to treat de­pres­sion or OCD, could quick­ly join the ranks of oth­er out­pa­tient treat­ments like mon­o­clon­al an­ti­bod­ies, or Mer­ck’s hot­ly an­tic­i­pat­ed an­tivi­ral mol­nupi­ravir.

The au­thors from Brazil­ian uni­ver­si­ties and Mc­Mas­ter Uni­ver­si­ty in On­tario wrote:

Our tri­al has found that flu­vox­am­ine, an in­ex­pen­sive ex­ist­ing drug, re­duces the need for ad­vanced dis­ease care in this high-risk pop­u­la­tion. A 10-day course of flu­vox­am­ine costs ap­prox­i­mate­ly US$4 even in well re­sourced set­tings. Our study com­pares favourably with the treat­ment ef­fects of more ex­pen­sive treat­ments in­clud­ing mon­o­clon­al an­ti­bod­ies for out­pa­tient treat­ment. The ab­solute num­ber of se­ri­ous ad­verse events as­so­ci­at­ed with flu­vox­am­ine was low­er than for place­bo and this might re­flect the mod­u­la­to­ry ef­fect of flu­vox­am­ine on sys­temic in­flam­ma­tion in these par­tic­i­pants.

David Boul­ware

David Boul­ware of the Uni­ver­si­ty of Min­neso­ta Med­ical School, who was un­af­fil­i­at­ed with the tri­al, told End­points News via email of the re­sults, “the out­comes were bet­ter among those who could tol­er­ate the med­i­cine, where the most com­mon side ef­fects were gas­troin­testi­nal in na­ture. Among those who took at least 80% of the flu­vox­am­ine, there was a two-thirds re­duc­tion in hos­pi­tal­iza­tions or ER vis­its – as well as deaths be­ing re­duced by 90% with on­ly one death in the flu­vox­am­ine [arm of the tri­al] ver­sus 12 with place­bo.”

The tri­al was de­signed and done in part­ner­ship with lo­cal pub­lic health au­thor­i­ties from 11 cities in Brazil to si­mul­ta­ne­ous­ly test po­ten­tial treat­ments for ear­ly dis­ease via a mas­ter pro­to­col. Mas­ter pro­to­cols have long been fa­vorites of top FDA and NIH lead­ers like Janet Wood­cock and Fran­cis Collins.

Pre­vi­ous­ly, a tri­al in the US of a high­er dose of flu­vox­am­ine (100 mg three times a day for 15 days) in­clud­ed a low­er risk group for the pri­ma­ry out­come but found no cas­es among 80 pa­tients re­ceiv­ing flu­vox­am­ine ver­sus six cas­es among 72 pa­tients re­ceiv­ing place­bo, ac­cord­ing to the Lancet pa­per. A large ob­ser­va­tion­al study from France al­so showed a re­duc­tion in the use of in­tu­ba­tion or death with the use of SS­RIs among 7,230 hos­pi­tal­ized Covid-19 pa­tients.

There are still two US tri­als in­ves­ti­gat­ing a low­er flu­vox­am­ine dose of 50 mg twice dai­ly which would have few­er side ef­fects and be more tol­er­a­ble, ac­cord­ing to Boul­ware.

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh’s Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy & Pre­scrib­ing and al­so un­af­fil­i­at­ed with the tri­al, told End­points that this is “a re­al­ly im­por­tant tri­al show­ing again the pow­er of these adap­tive plat­form tri­als. The big ques­tions were stat­ed at the end of the ed­i­to­r­i­al: what does this mean for vac­ci­nat­ed peo­ple, and how does this fit in terms of oth­er ther­a­pies we now have, like mon­o­clon­al an­ti­bod­ies and mol­nupi­ravir. The drug again high­lights the im­por­tance of ear­ly and quick di­ag­no­sis, which is re­quired to get peo­ple med­ica­tions as ear­ly as pos­si­ble.”

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

WHO rec­om­mends against the use of con­va­les­cent plas­ma for Covid-19

The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.

The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:

Bolt Bio CEO Randy Schatzman

Bolt Bio goes bust as in­vestors boo sin­gle re­sponse in ear­ly test against HER2-ex­press­ing tu­mors

Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech said Monday.

BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.

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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)

Bio­haven shakes up lead­er­ship team as it feels the heat from mi­graine com­peti­tors

As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.

Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.

Gilead re­calls 2 lots of Vek­lury af­ter in­ves­ti­ga­tion con­firms com­plaint of glass par­tic­u­lates

Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.

Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.