UP­DAT­ED — Covid-19 roundup: WHO all but con­firms virus not man-made; Neu­roRx, Re­lief say they don't know if IV treat­ment works

The WHO has been work­ing on trac­ing the ori­gins of the Covid-19 pan­dem­ic in re­cent weeks, send­ing a field team to Wuhan, Chi­na, to in­ves­ti­gate. And Tues­day morn­ing, they all but ruled out the pos­si­bil­i­ty that the virus was man-made.

Re­searchers with the or­ga­ni­za­tion said the nov­el coro­n­avirus stem­ming from the re­sult of a lab ac­ci­dent was “ex­treme­ly un­like­ly,” con­firm­ing what most health ex­perts had said since it first emerged in late 2019. The ev­i­dence con­tin­ues to point to­ward the virus spread­ing from an­i­mals to hu­mans.

“All the work that has been done on the virus and try­ing to iden­ti­fy its ori­gin con­tin­ue to point to­ward a nat­ur­al reser­voir,” lead sci­en­tist Pe­ter Ben Em­barek said at a news con­fer­ence, per a New York Times re­port.

In speak­ing with re­porters, Em­barek swat­ted down the lab ac­ci­dent the­o­ry that had been pro­mot­ed at times by for­mer Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion, among oth­ers. “It was very un­like­ly that any­thing could es­cape from such a place,” he said, not­ing the heavy safe­ty pro­to­cols.

The WHO mis­sion comes af­ter months of crit­i­cism that the or­ga­ni­za­tion has gone out of its way to de­fer to the Chi­nese gov­ern­ment in its as­sess­ments of the pan­dem­ic. Chi­na had been re­luc­tant to al­low the sci­en­tists in­to the coun­try but ul­ti­mate­ly ac­qui­esced last month, let­ting the group of 14 con­duct their in­ves­ti­ga­tion.

The coun­try al­so used Tues­day’s news con­fer­ence to con­tin­ue as­sert­ing that the virus first ap­peared else­where, a the­o­ry that many health ex­perts dis­miss. WHO sci­en­tists have said they will in­ves­ti­gate these claims while al­so call­ing for more re­search in­to an­i­mals sold at a mar­ket in Wuhan where some of the first cas­es were re­port­ed.

Ef­fi­ca­cy for se­vere Covid-19 treat­ment still TBD, Neu­roRx and Re­lief say

Neu­roRx and Re­lief Ther­a­peu­tics have teamed up on de­vel­op­ing in­haled and IV for­mu­la­tions of an ex­per­i­men­tal drug for se­vere Covid-19 cas­es, and on Tues­day re­vealed that the ju­ry is still out on whether or not the IV pro­gram works as in­tend­ed.

The pair said they are still work­ing to de­ter­mine whether or not the can­di­date, dubbed Zye­sa­mi, met the pri­ma­ry end­point of re­cov­ery from res­pi­ra­to­ry fail­ure with­in 28 days in a Phase IIb/III study. Pa­tients are be­ing fol­lowed through 60 days.

The pair al­so re­vealed key sec­ondary end­point da­ta, in­clud­ing that re­searchers did not see dif­fer­ences in sur­vival ben­e­fit af­ter four weeks. Neu­roRx and Re­lief ap­peared to blame that on over­all ICU care im­prov­ing, say­ing in a re­lease “With the im­prove­ment in sur­vival since the start of the pan­dem­ic, dif­fer­ences in sur­vival were not seen at day 28.”

In­vestors in Re­lief were ap­par­ent­ly not pleased, send­ing shares of the Swiss pen­ny stock down more than 30%.

138 pa­tients out of a to­tal of 203 sur­vived in that time­frame, with 91 of those tak­ing Zye­sa­mi and 47 on stan­dard of care. Pa­tients were ran­dom­ized in­to the drug arm at a 2-to-1 ra­tio.

The com­pa­nies at­tempt­ed to high­light a small pos­i­tive in an­oth­er sec­ondary end­point, though, not­ing that pa­tients who were treat­ed with Zye­sa­mi on top of the max­i­mal stan­dard of care ben­e­fit­ed over place­bo. They mea­sured this out­put us­ing time to dis­charge from the hos­pi­tal, say­ing that in six of eight evalu­able cas­es pa­tients saw a three-day me­di­an dif­fer­ence in hos­pi­tal stay.

But by the com­pa­nies’ own ad­mis­sion, that find­ing may not end up mean­ing any­thing.

“The sec­ondary end­point da­ta re­port­ed to­day should not cre­ate an ex­pec­ta­tion that the pri­ma­ry end­point will be met over­all or for any sub­group,” the com­pa­nies said.

End­points News sent out a re­quest for com­ment on the news, and re­ceived this in an emailed re­sponse from CEO Jonathan Javitt:

“The end­point da­ta we re­port­ed are sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly mean­ing­ful to doc­tors, pa­tients, and fam­i­lies. Re­duced hos­pi­tal stay has been a key ba­sis for reg­u­la­to­ry de­ter­mi­na­tions dur­ing the COVID pan­dem­ic and the re­duced hos­pi­tal stay seen in this pop­u­la­tion was shown in a pop­u­la­tion that lacks ef­fec­tive ther­a­pies. These da­ta are there­fore ma­te­r­i­al.”

The can­di­date it­self is a for­mu­la­tion of va­soac­tive in­testi­nal polypep­tide, which is known to be high­ly con­cen­trat­ed in the lungs. Though Tues­day’s re­sults come from the IV ver­sion of the pro­gram, the in­haled for­mu­la is cur­rent­ly in a Phase II/III study.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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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).

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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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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