In­ter­fer­on be­ta-1a can­di­date for COPD ad­vances to PhI­II to test its po­ten­tial against Covid-19

An­oth­er re­pur­posed drug is en­ter­ing Phase III to see if it pass­es the test against Covid-19.

In a small Phase II tri­al, Synair­gen says hos­pi­tal­ized Covid-19 pa­tients who took its in­hal­able in­ter­fer­on be­ta-1a for­mu­la­tion, SNG001, were twice as like­ly to re­cov­er with­in 14 days than pa­tients on a place­bo. CEO Richard Mars­den said the Southamp­ton, UK-based biotech is launch­ing the can­di­date — which was al­ready in de­vel­op­ment for COPD and asth­ma — in­to a 900-per­son Phase III study in the com­ing weeks.

Richard Mars­den

The Phase II tri­al be­gan in March and was car­ried out at 9 UK hos­pi­tals. A to­tal of 48 pa­tients were giv­en SNG001 and 50 a place­bo dai­ly for up to 14 days. Synair­gen fol­lowed up for a max­i­mum of 28 days af­ter start­ing treat­ment, and con­duct­ed sev­er­al analy­ses us­ing the World Health Or­ga­ni­za­tion’s Or­di­nal Scale for Clin­i­cal Im­prove­ment. While sta­tis­ti­cal sig­nif­i­cance was on­ly achieved in some of the analy­ses, Mars­den said the re­sults were enough to jus­ti­fy pro­gress­ing the can­di­date in­to Phase III.

“Some of them hap­pen so in­fre­quent­ly,” Mars­den said of the analy­ses. “So things like death — there were on­ly three deaths in the tri­al. They were all on place­bo, so we didn’t an­a­lyze that be­cause it’s too small to an­a­lyze. Go­ing on­to ven­ti­la­tors was quite a rare event, so that one didn’t reach sta­tis­ti­cal sig­nif­i­cance, al­though it was nu­mer­i­cal­ly in fa­vor of (the) drug.”

SNG001 achieved sta­tis­ti­cal sig­nif­i­cance in pre­vent­ing pa­tients from wors­en­ing to need non-in­va­sive ven­ti­la­tion or high-flow oxy­gen in a first analy­sis, but just missed the mark in a sec­ond more con­ser­v­a­tive analy­sis, Mars­den said. But what the com­pa­ny has be­come most in­ter­est­ed in is time to full re­cov­ery.

For the pur­pos­es of the study, Synair­gen de­fined “full re­cov­ery” as the point where a pa­tient no longer ex­pe­ri­ences lim­i­ta­tions in every­day ac­tiv­i­ties. By that mea­sure, 21 pa­tients (44%) in the treat­ment arm reached full re­cov­ery over the 14-day treat­ment course, ver­sus 11 (22%) in the place­bo group.

“The thing that we’re most ex­cit­ed about is get­ting peo­ple back to this lev­el of no lim­i­ta­tion of ac­tiv­i­ties, and you’re more than twice as like­ly — ap­proach­ing three times as like­ly in some of the analy­ses — of get­ting back to that lev­el if you’re on drug com­pared to place­bo,” Mars­den said.

Ac­cord­ing to re­sults pub­lished in the Lancet, 6 pa­tients on the in­ter­fer­on be­ta-1a for­mu­la­tion (13%) de­vel­oped se­vere dis­ease, com­pared to 11 (22%) in the place­bo group.

Nathan Peif­fer-Smad­ja, a lead au­thor who wasn’t in­volved in the study, wrote in a com­ment: “The num­ber of pa­tients en­rolled in this pi­lot clin­i­cal tri­al is of course small. In ad­di­tion, this study nei­ther showed any im­pact of the eval­u­at­ed treat­ment on time to dis­charge nor on mor­tal­i­ty, al­though the study was ob­vi­ous­ly not pow­ered to re­spond to the lat­ter ques­tion. Larg­er ran­domised clin­i­cal tri­als are there­fore need­ed to con­firm these re­sults.”

So why the small tri­al size? It’s what the WHO rec­om­mend­ed back in Jan­u­ary, Mars­den said. Plus, “we didn’t have enough drug to do more pa­tients,” he added.

“So, that was us putting … our chips on the ta­ble and see­ing if the drug could do some­thing help­ful. And I think what was very in­ter­est­ing (was) that dur­ing Q2 and Q3 this year, there’s been a mount­ing in lit­er­a­ture which sug­gests that this virus is sup­press­ing the pro­duc­tion of in­ter­fer­on be­ta as part of its strat­e­gy to evade the im­mune sys­tem,” he said.

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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

Endpoints Premium

Premium subscription required

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

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.