UK biotech rock­ets up on Covid-19 'break­through' for in­haled in­ter­fer­on be­ta — can its small study live up to the boast?

In­ter­fer­on be­ta, a cy­tokine ap­proved and wide­ly used in in­jectable forms, sur­faced very ear­ly on as a po­ten­tial treat­ment for Covid-19. A British biotech now says its in­haled for­mu­la­tion of the drug helped hos­pi­tal­ized pa­tients re­cov­er — and low­ered their risk of do­ing worse.

It’s a small study in­volv­ing on­ly 101 pa­tients and missed some end­points, but Synair­gen said the re­sults could sig­nal a “ma­jor break­through.” If true, that would al­so mark se­ri­ous val­i­da­tion for a drug that As­traZeneca once li­censed but even­tu­al­ly aban­doned as an asth­ma ther­a­py.

First, the pos­i­tives:

  • Pa­tients in the SNG001 arm saw their risk of re­quir­ing ven­ti­la­tion or dy­ing re­duced by 79% com­pared to those who re­ceived place­bo, with a mar­gin­al­ly pos­i­tive p-val­ue of 0.046.
  • They were al­so “more than twice as like­ly to re­cov­er” — to the point where they can go about their dai­ly lives de­spite the in­fec­tion — al­though the dif­fer­ence here wasn’t spelled out (p=0.043).
Stephen Hol­gate

Al­though the com­pa­ny didn’t use the ex­act word­ing, these out­comes ap­pear to align with the pri­ma­ry end­point list­ed on a tri­al post­ing, which mea­sures clin­i­cal im­prove­ment dur­ing the 16-day dos­ing pe­ri­od on an 8-point scale. No fur­ther de­tails on how pa­tients im­proved or wors­ened along that scale were pro­vid­ed.

Shares shot up 173.97% up­on the news, reach­ing 100 GBX on the Lon­don Stock Ex­change.

One oth­er sec­ondary end­point stood out, while oth­ers fell short.

Breath­less­ness, a se­vere symp­tom de­signed to be as­sessed along­side cough and spu­tum, was “marked­ly re­duced” for pa­tients who got the drug (p=0.007). The num­bers for cough and spu­tum weren’t avail­able.

More­over, Synair­gen not­ed, three par­tic­i­pants died af­ter be­ing ran­dom­ized to place­bo, com­pared to ze­ro deaths in the SNG001 group — not that they can draw any con­clu­sion from it.

SNG001 works by send­ing high lo­cal con­cen­tra­tions of in­ter­fer­on be­ta, a “nat­u­ral­ly oc­cur­ring an­tivi­ral pro­tein,” to re­store the lung’s de­fense against the virus, ac­cord­ing to Stephen Hol­gate, a Uni­ver­si­ty of Southamp­ton pro­fes­sor who co-found­ed Synair­gen.

Richard Mars­den

But the tri­al, which was con­duct­ed across 9 sites in the UK, found that pa­tients who al­ready re­quired oxy­gen at ad­mis­sion didn’t seem to ben­e­fit as much. The “nu­mer­i­cal ad­van­tage” in the like­li­hood of hos­pi­tal dis­charge didn’t trans­late to a sta­tis­ti­cal­ly sig­nif­i­cant gain, with me­di­an time to dis­charge in the SNG001 group at 6 days and the place­bo group, 9 days (p=0.096).

Synair­gen al­so want­ed to high­light that pa­tients ap­peared to be more like­ly to have re­cov­ered by the end of treat­ment if they were on the drug, though it was again not sta­tis­ti­cal­ly sig­nif­i­cant.

What does this all mean? The com­pa­ny is con­duct­ing fur­ther analy­sis and it has pre­vi­ous­ly said a piv­otal tri­al would be need­ed. Mars­den said they are now work­ing with reg­u­la­tors and oth­er groups to “progress this po­ten­tial COVID-19 treat­ment as rapid­ly as pos­si­ble.”

It’s un­clear how the da­ta and those from a fol­low-up tri­al would be squared against in­ter­fer­on be­ta ad­min­is­tered in more tra­di­tion­al, com­mer­cial­ly avail­able forms. These are be­ing test­ed in com­bi­na­tion with the HIV drug Kale­tra in both the UK’s RE­COV­ERY tri­al and the WHO-led SOL­I­DAR­I­TY study, two of the largest mas­ter pro­to­cols or­ga­nized to weed out a ros­ter of po­ten­tial Covid-19 drugs.

A study out of Is­rael, pub­lished days ago, con­clud­ed that al­though in­ter­fer­on be­ta “did not change time to reach the clin­i­cal re­sponse, adding to the stan­dard of care sig­nif­i­cant­ly in­creased dis­charge rate on day 14 and de­creased 28-day mor­tal­i­ty.”

Be­fore the pan­dem­ic swept it up, Synair­gen had been test­ing SNG001 in pa­tients with chron­ic ob­struc­tive pul­monary dis­ease. Back in 2014 As­traZeneca in-li­censed the drug for asth­ma and kicked off a study, on­ly to halt it ear­ly in 2016 af­ter de­ter­min­ing that an over­all low num­ber of ex­ac­er­ba­tions among the asth­ma pa­tients re­cruit­ed in that cold sea­son would make it dif­fi­cult to see if they could ac­tu­al­ly hit the pri­ma­ry end­point that had been laid out.

“When we’ve col­lect­ed cells from pa­tients with COPD and asth­ma and old­er peo­ple…we find that their lung cells don’t re­spond very well to virus­es,” Mars­den told End­points News in a pre­vi­ous in­ter­view. “We have al­so along the way al­ways rec­og­nized that with an emerg­ing virus, the drug could be used.”

Whether it will be adopt­ed is a whole oth­er ques­tion like­ly won’t take long to an­swer in the fran­tic R&D race for treat­ments.

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

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

Cure­Vac touts old­er adult da­ta for GSK-part­nered Covid-19, flu can­di­dates

Germany’s CureVac reported data Monday on older patients to beef up plans to advance vaccines for Covid-19 and seasonal flu.

In short, the Covid-19 data reveal the vaccine candidate, known as CV0501 targeting Omicron’s BA.1 variant, boosted titers of neutralizing antibodies by 13.3-fold after four weeks at the lowest 12 µg dose level. The data in these cohorts are still small, with 10 patients enrolled per dose. Some patients also received 25 and 50 µg doses.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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