Jean-Pierre Sommadossi, Atea CEO

Covid-19 roundup: Atea Phar­ma­ceu­ti­cals launch­es an­tivi­ral in­to PhI­II tri­al; Cell­tri­on's an­ti­body shows promise against vari­ant

About a year af­ter jump­ing in­to the Covid-19 fight with its lead an­tivi­ral, Atea Phar­ma­ceu­ti­cals has launched a Phase III tri­al in mild to mod­er­ate pa­tients who are not hos­pi­tal­ized.

The drug (and com­pa­ny) come from Jean-Pierre Som­ma­dos­si, the founder of Idenix and a co-founder of Phar­mas­set. The com­pa­ny de­cid­ed to di­vert all their at­ten­tion to Covid-19 last Feb­ru­ary, then pulled in $215 mil­lion to launch a cross-coun­try Phase II tri­al in May.

“Hope­ful­ly we will not have a sec­ond wave,” Som­ma­dos­si told End­points News at the time. “But if we have a sec­ond wave, we need to be ready this time.”

In Oc­to­ber, Roche put down $350 mil­lion up­front plus undis­closed mile­stones and roy­al­ties for ex-US rights to the can­di­date, dubbed AT-527, as an oral an­tivi­ral treat­ment for Covid-19. The ther­a­py works by block­ing the vi­ral RNA poly­merase en­zyme need­ed for vi­ral repli­ca­tion, ac­cord­ing to Roche.

The Phase III MORN­INGSKY tri­al will en­roll 1,400 non-hos­pi­tal­ized pa­tients, in­clud­ing ado­les­cents, who are with­in five days of symp­tom on­set. The study’s pri­ma­ry end­point will eval­u­ate the time to im­prove­ment of symp­toms com­pared to a place­bo. Par­tic­i­pants will come from a va­ri­ety of clin­i­cal tri­al sites world­wide, in­clud­ing in Japan, ac­cord­ing to Atea.

In ad­di­tion to MORN­INGSKY, Roche and Atea are test­ing the can­di­date in a glob­al Phase II for hos­pi­tal­ized pa­tients with mod­er­ate Covid-19, and a Phase II vi­rol­o­gy study in out­pa­tients with mild to mod­er­ate sick­ness.

“As a di­rect-act­ing an­tivi­ral, AT-527 aims to pre­vent dis­ease pro­gres­sion by in­hibit­ing vi­ral repli­ca­tion and there­by re­duc­ing the sever­i­ty of dis­ease, pre­vent­ing or short­en­ing hos­pi­tal­iza­tion, and al­so po­ten­tial­ly pre­vent­ing trans­mis­sion of the virus to oth­ers,”  Som­ma­dos­si said in a state­ment. “This makes it well-suit­ed for po­ten­tial use in both pre- and post-ex­po­sure pro­phy­lac­tic set­tings and com­ple­men­tary to vac­cines.” — Nicole De­Feud­is 

Cell­tri­on’s mAb shows suc­cess against South African vari­ant

Pre-clin­i­cal tri­al re­sults from Cell­tri­on Group’s an­ti-Covid-19 mon­o­clon­al an­ti­body reg­dan­vimab showed neu­tral­iza­tion of the South African vari­ant, the com­pa­ny an­nounced Thurs­day.

Reg­dan­vimab proved ef­fec­tive in an in vi­vo mod­el by bind­ing against the re­cep­tor bind­ing do­main in three mu­ta­tions (K417N, E484K and N501Y) of the vari­ant, Cell­tri­on said in a re­lease. How­ev­er, it al­so showed re­duced sus­cep­ti­bil­i­ty against the South African vari­ant in a live virus and pseu­do-virus in vit­ro study though there was no sig­nif­i­cant dif­fer­ence be­tween the vari­ants and the wild type when ob­serv­ing vi­ral res­pi­ra­to­ry in­fec­tion.

In a state­ment, head of med­ical and mar­ket­ing Ho-Ung Kim said, “Faced with the rapid spread of COVID-19 vari­ants, glob­al ac­cess to ef­fec­tive an­ti­body treat­ment is fun­da­men­tal­ly im­por­tant to re­duce the dis­ease pro­gres­sion rate to se­vere COVID-19 and help out­pa­tients avoid hos­pi­tal­iza­tion and al­le­vi­ate the bur­den on the health care sys­tem. We have com­menced the de­vel­op­ment of a neu­tral­iz­ing an­ti­body cock­tail with CT-P59 against new emerg­ing strains in the UK and South Africa and we will con­tin­ue to fur­ther in­ves­ti­gate the neu­tral­iz­ing an­ti­bod­ies and oth­er re­spons­es to pro­tect against cur­rent SARS-CoV-2 strains and emerg­ing vari­ants.”

In March, the Eu­ro­pean Med­i­cines Agency an­nounced that the mAb could be used as treat­ment for adults who don’t re­quire sup­ple­men­tal oxy­gen and are at high risk of pro­gress­ing to se­vere Covid-19. The EMA said that most side ef­fects re­port­ed were mild or mod­er­ate, but re­sults weren’t ro­bust enough to reach a con­clu­sion on the med­i­cine’s ben­e­fits.

The com­pa­ny be­gan mass pro­duc­ing the mAb in Sep­tem­ber 2020 in hopes of get­ting emer­gency use au­tho­riza­tion. — Josh Sul­li­van

Pfiz­er/BioN­Tech could have vac­cine tri­al re­sults for younger chil­dren by Sep­tem­ber — re­port

BioN­Tech CEO Ugur Sahin says the com­pa­ny could have a look at how its Pfiz­er-part­nered Covid-19 vac­cine works in ba­bies as young as six months old by Sep­tem­ber, ac­cord­ing to Reuters. 

“In Ju­ly, the first re­sults could be avail­able for the five to 12 year olds, in Sep­tem­ber for the younger chil­dren,” he told the Ger­man mag­a­zine Der Spiegel, per Reuters.

Ear­li­er this month, Pfiz­er and BioN­Tech asked the FDA to ex­pand its EUA to in­clude ado­les­cents 12 to 15 years old.

A cou­ple weeks ago, Mod­er­na said its Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US. Mean­while, its Phase II/III Kid­COVE study was still re­cruit­ing chil­dren be­tween 6 months and 11 years old. — Nicole De­Feud­is

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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