Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

De­spite hav­ing al­ready re­ceived an emer­gency use au­tho­riza­tion for its Covid-19 an­ti­body in non-hos­pi­tal­ized pa­tients last No­vem­ber, Re­gen­eron con­tin­ued to con­duct tri­als to eval­u­ate the cock­tail’s ef­fec­tive­ness. Now, the big biotech has re­ceived some good news from their IDMC.

George Yan­copou­los

On the IDMC’s rec­om­men­da­tion, Re­gen­eron will be shut­ting down en­roll­ment in the place­bo group of a Phase III out­pa­tient tri­al for their REGN-COV pro­gram — a mix of casiriv­imab with imde­vimab — af­ter in­ves­ti­ga­tors found “clear clin­i­cal ef­fi­ca­cy” in both dos­es com­pared to the con­trol, the com­pa­ny an­nounced Thurs­day. CSO George Yan­copou­los al­so said in a state­ment that the cock­tail can neu­tral­ize emerg­ing strains of the nov­el coro­n­avirus.

“Our cock­tail ap­proach us­ing two func­tion­al­ly-in­de­pen­dent an­ti­bod­ies safe­guards against vari­ants that may im­pact po­ten­cy to a sin­gle an­ti­body,” Yan­copou­los said.

Re­gen­eron still does not have ac­cess to the un­blind­ed da­ta, in­clud­ing the rel­a­tive treat­ment ben­e­fit of the 1,200mg and 2,400mg dos­es, and said they will re­lease re­sults next month. Re­searchers will con­tin­ue en­rolling pa­tients at both dosage lev­els.

This is not the on­ly tri­al Re­gen­eron is con­duct­ing for its ex­per­i­men­tal ther­a­py. Last month, the com­pa­ny re­leased in­ter­im da­ta from a sep­a­rate tri­al look­ing at whether it could pre­vent symp­to­matic in­fec­tions from oc­cur­ring in peo­ple ex­posed through a fam­i­ly con­nec­tion.

Those da­ta showed that ze­ro in­fec­tions man­i­fest­ed among 186 peo­ple treat­ed in the treat­ment arm, com­pared to eight of 223 in­fec­tions oc­cur­ring in the place­bo group. Ad­di­tion­al­ly, when adding asymp­to­matic in­fec­tions, there were 23 cas­es among the place­bo pa­tients com­pared to 10 in the cock­tail arm.

In that study, re­searchers al­so not­ed sig­nif­i­cant­ly low­er peak vi­ral loads and short­er pe­ri­ods of vi­ral load­ing for the drug arm. Full da­ta are ex­pect­ed ear­ly in the sec­ond quar­ter.

Fol­low­ing an EUA for the cock­tail last No­vem­ber, the US has been rapid­ly buy­ing up sup­ply of the ther­a­py. Last month, Re­gen­eron scored a $2.625 bil­lion sup­ply deal with the gov­ern­ment. The biotech’s best-case sce­nario for sup­ply is to de­liv­er 1.25 mil­lion dos­es by the end of June, but that may de­pend on the FDA’s stance on the low­er dose — cur­rent­ly, on­ly the 2,400mg cock­tail dose is au­tho­rized.

If reg­u­la­tors don’t soon ex­pand the EUA to cov­er the low­er-dose reg­i­men, which is still be­ing test­ed for the same pop­u­la­tion of non-hos­pi­tal­ized, mild to mod­er­ate Covid-19 pa­tients at high risk of pro­gres­sion, Re­gen­eron will on­ly be able to sup­ply around 750,000 fin­ished dos­es by that time.

In the com­pa­ny’s piv­otal out­pa­tient tri­al, on­ly the high­er dose helped new­ly di­ag­nosed pa­tients achieve sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in virus lev­els and re­quire few­er med­ical vis­its. The cock­tail is not au­tho­rized for hos­pi­tal­ized pa­tients or pa­tients re­quir­ing sup­ple­men­tal oxy­gen, ei­ther due to Covid-19 or those with a high-risk co­mor­bid­i­ty.

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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.