Stal­ler­genes Greer's dust mite al­ler­gy drug clears piv­otal study, edges clos­er to ap­proval

In a bid to tack­le one of the most com­mon al­ler­gens that asth­ma pa­tients are sen­si­tive to, Stal­ler­genes Greer’s house dust mite im­munother­a­py is one step clos­er to win­ning ap­proval af­ter re­port­ing suc­cess­ful late-stage da­ta on Tues­day.

The Lon­don-based al­ler­gy biotech said its sub­lin­gual tablet STA­GR320 pro­voked a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in house dust mite(HDM)-in­duced al­ler­gic rhini­tis symp­toms (p<0.0001) against a place­bo, meet­ing the main goal of the study.

Da­ta from the tri­al of 1,600 pa­tients aged 12-65 that had suf­fered symp­toms for at least one year are com­pelling enough for reg­u­la­to­ry sub­mis­sions in the Unit­ed States and Eu­rope, the com­pa­ny said. The ear­li­est the drug could hit the mar­ket in ei­ther ge­og­ra­phy is 2020, chief Fer­ey­doun Firouz told End­points News. 

House dust mites, which are too mi­nus­cule to be de­tect­ed by the naked eye, are close rel­a­tives of ticks and spi­ders and gorge on skin shed by hu­mans. An av­er­age adult hu­man may shed up to 1.5 grams of skin in a day — enough to feed one mil­lion dust mites, ac­cord­ing to the Asth­ma and Al­ler­gy Foun­da­tion of Amer­i­ca, which es­ti­mates HDM-in­duced al­ler­gies af­fect some 20 mil­lion Amer­i­cans.

Right now, many pa­tients who suf­fer from HDM-in­duced al­ler­gic rhini­tis go un­treat­ed or take med­ica­tions such as an­ti­his­t­a­mines that on­ly treat the symp­toms of the al­ler­gy, un­like  STA­GR320, which ad­dress­es the un­der­ly­ing cause of the dis­ease and can pro­vide long-last­ing re­duc­tion of al­ler­gy symp­toms, said Firouz, not­ing that most pa­tients seek re­lief through symp­to­matic med­ica­tions and on­ly rough­ly 10% of pa­tients with al­ler­gic rhini­tis are treat­ed with al­ler­gy im­munother­a­py.

Al­ler­gic rhini­tis af­fects more than half a bil­lion peo­ple glob­al­ly, and more than one-third of those are af­fect­ed as a re­sult of an al­ler­gy to house dust mites, added Firouz. The risk of de­vel­op­ing asth­ma is about six times high­er in pa­tients with an al­ler­gy to house dust mites than those al­ler­gic to pol­lens, ac­cord­ing to Stal­ler­genes Greer.

The im­munother­a­py, if ap­proved, will like­ly com­pete with Mer­ck’s $MRK Odac­tra, which was giv­en the FDA nod last year as an al­ter­na­tive to al­ler­gy shots ad­min­is­tered to man­age symp­toms. How­ev­er, Odac­tra’s ap­proval on­ly cov­ers adults, while STA­GR320 could po­ten­tial­ly win ap­proval for use in ado­les­cents in ad­di­tion to adults. In Eu­rope, STA­GR320 will po­ten­tial­ly be stacked up against ALK’s Acarizax.

UP­DAT­ED: Roche bags 'break­through' an­ti-fi­bro­sis drug in $1.4B biotech buy­out deal

Roche is snapping up a “breakthrough” anti-fibrotic drug in a $1.4 billion buyout.

The pharma giant announced Friday that it is acquiring Promedior, primarily to get its hands on PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that has nailed down mid-stage clinical data on idiopathic pulmonary fibrosis and demonstrating its potential for a range of fibrotic conditions.

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Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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No­var­tis spin­out’s first an­ti-ag­ing PhI­II is a flop, so now they’ll turn to Parkin­son’s chal­lenge as shares wilt

Novartis spinout resTORbio is grappling with the collapse of its lead clinical program this morning — an anti-aging R&D failure that will badly damage their rep in the field.

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No­var­tis scores its lat­est FDA OK — this time for a new sick­le cell dis­ease drug picked up in a $665M deal

Novartis’ decision to buy Oklahoma-based biotech Selexys 3 years ago for up to $665 million has paid off with an FDA approval today.

Blessed with the FDA’s breakthrough drug designation for a speedy review, the pharma giant has pinned down an approval for crizanlizumab, a new therapy designed to reduce the frequency of painful incidents of vaso-occlusive crises among sickle cell disease patients 16 or older.

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As­traZeneca gains EU nod for di­a­betes triple; Am­gen and Duke launch re­al-world PC­SK9 ob­ser­va­tion­al study

→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.

Five drugs, in­clud­ing two No­var­tis ther­a­pies, win EMA en­dorse­ment

As is custom, an EMA panel on Friday issued its weekly recommendations on marketing applications submitted by drug developers. This week, the agency backed the use of five new therapies — including two Novartis drugs — but issued no negative reviews.

Novartis’ S1P drug for relapsing forms of multiple sclerosis (MS) drug, Mayzent (known chemically as siponimod), which was approved by the FDA in March — has been given the nod by the EMA. The Swiss drugmaker already sells its other MS drug, Gilenya, in both regions.

Atom­wise's X-37 spin­out gets $14.5 mil­lion to launch AI dis­cov­ery ef­forts

The folks behind Atomwise’s spinout X-37 like to think in cosmological metaphors, and you can think of their AI drug development model as probes sent into space from a central station. That station just got $14.5 million in Series A funding from DCVC Bio, Alpha Intelligence Capital and Hemi Ventures to back those missions.

X-37 uses Atomwise’s AI platform to identify drug targets and – unlike the parent company, which largely sticks to computers  – bring those into a wet lab and preclinical testing.  In addition to AI professionals, it’s led in by part by drug developers from Velocity Pharmaceutical Development.

Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

→ Abbott Laboratories has named a successor to CEO Miles White after he announced that he was stepping down in March after 21 years of service. Robert Ford, the company’s COO and president, will take the helm. Ford is known for his work in the $25 billion merger between St. Jude Medical into Abbott in January 2017. White will remain with the company as executive chairman of the board. 

→ After snapping up Novartis’ Swiss facility, Novartis Center of Excellence, in July, Lonza has announced that their CEO, Marc Funk, is hitting the exit for “personal reasons.” Funk has been the CEO of the company for less than a year — brought onto the company back in March. In the meantime, chairman Albert Baehny will serve as interim CEO. 

UCB adds on more pos­i­tive PhI­II da­ta for IL-17A/17F in­hibitor bimek­izum­ab, clear­ing a path to the FDA

A month after posting positive top-line data from their first Phase III trial of the IL-17A/17F inhibitor bimekizumab, Belgium’s UCB says they’ve added more upbeat results from their second late-stage test in moderate-to-severe plaque psoriasis.

That leaves the company on track for regulatory submissions in the middle of next year, says CMO Iris Loew-Friedrich.
Their drug beat out a placebo on the co-primaries — a 90% improvement in PASI 90 (the Psoriasis Area and Severity Index) and Investigator Global Assessment (IGA) response of clear or almost clear (IGA 0/1) at week 16, compared to placebo. Investigators also boasted of hitting some key secondaries.
UCB is angling to enter an increasingly crowded market space.
In their first of 3 Phase III studies for bimekizumab, researchers touted top-line wins on statistically significant results on clearing plaque psoriasis, including a victory over J&J’s IL-23 contender Stelara on key endpoints. The drug targets both IL-17A and IL-17F, a modification on the IL-17A strategy laid out for Taltz (Eli Lilly) and Cosentyx (Novartis). And the new group also includes J&J’s Tremfya and AbbVie’s Skyrizi.

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