Urovan­t's over­ac­tive blad­der drug scores in mid-stage tri­al

Urovant Sci­ences said its ex­per­i­men­tal over­ac­tive blad­der drug vibegron im­proved symp­toms in a large mid-stage study, a wel­come sig­nal for the com­pa­ny as it eval­u­ates the drug fur­ther in a phase III ini­ti­at­ed ear­li­er this year.

The phase IIb two-stage tri­al en­rolled more than 1,300 pa­tients with OAB symp­toms. In the first stage, pa­tients ei­ther re­ceived once-dai­ly oral vibegron (3 mg, 15 mg, 50 mg or 100 mg), the uri­nary in­con­ti­nence drug toltero­dine (4 mg); or a place­bo for eight weeks. In the sec­ond stage, pa­tients were giv­en ei­ther vibegron (100 mg); toltero­dine (4 mg); a com­bi­na­tion vibegron (100 mg) and toltero­dine (4 mg); or place­bo for four weeks. The ob­jec­tive of the study was to eval­u­ate the safe­ty and ef­fi­ca­cy of vibegron as a once-dai­ly oral treat­ment for OAB pa­tients, re­gard­less of urge in­con­ti­nence.

Kei­th Katkin, Urovant CEO

Pa­tients giv­en the high­er dos­es of vibegron (50 mg and 100 mg) ex­pe­ri­enced sta­tis­ti­cal­ly sig­nif­i­cant de­creas­es in the dai­ly rate of uri­na­tion (p=0.007 and p<0.001 re­spec­tive­ly), ur­gency uri­nary in­con­ti­nence episodes (p<0.001 and p<0.001 re­spec­tive­ly), to­tal in­con­ti­nence episodes (p=0.005 and p=0.007) and ur­gency episodes (p=0.024 and p<0.001) at week 8. In the sec­ond tranche of the study, the ef­fi­ca­cy of vibegron monother­a­py on the pri­ma­ry end­point — re­duc­tion in uri­na­tion — was al­so sta­tis­ti­cal­ly sig­nif­i­cant, the com­pa­ny said.

Toltero­dine, sold as De­trol by Pfiz­er $PFE in the Unit­ed States, be­longs to a class of drugs called an­timus­carinics that are de­signed to in­hib­it mus­cle con­trac­ture and have been the on­ly avail­able treat­ments for decades. But they’re not de­signed specif­i­cal­ly for the blad­der and are as­so­ci­at­ed with a host of un­pleas­ant ad­verse-ef­fects, mak­ing them an un­pop­u­lar choice with pa­tients, es­pe­cial­ly in the el­der­ly.

Tri­al da­ta in­di­cat­ed that the mag­ni­tude of max­i­mal re­spons­es with the two high­er vibegron dos­es was of­ten nu­mer­i­cal­ly greater than toltero­dine, re­searchers wrote in the jour­nal Eu­ro­pean Urol­o­gy. “In ad­di­tion, these re­sults pro­vide the proof of con­cept that con­comi­tant dos­ing of vibegron and an an­timus­carinic can pro­duce mod­est symp­tom im­prove­ment ver­sus an an­timus­carinic alone”, they not­ed.

In the tri­al, all vibegron dos­es were well tol­er­at­ed. The in­ci­dence of dry mouth was high­er with pa­tients giv­en toltero­dine than those on vibegron monother­a­py, Urovant said.

The ex­act cause of OAB is un­known, which makes it dif­fi­cult to treat. More than 30 mil­lion over the age of 40 suf­fer symp­toms in the Unit­ed States ac­cord­ing to Urovant $UROV.

End­points News / Pharm­cube BI­IS18 Con­fer­ence in Shang­hai

Click on the im­age to see the full-sized ver­sion

Urovant is one of Vivek Ra­maswamy’s many “vants”, which are sub­sidiaries un­der the con­glom­er­ate Roivant Sci­ences brand. Last week Ra­maswamy told End­points News at the #BI­IS18 sum­mit that his strat­e­gy can be un­der­stood as an “Al­pha­bet for health­care”, a ref­er­ence to Google co-founder Lar­ry Page’s play­book of set­ting loose Google, YouTube, and even com­pa­nies like Cal­i­co and Ver­i­ly as se­mi-au­tonomous units that are led by the moth­er­ship. To date, Ra­maswamy has raised $3 bil­lion for his com­pa­nies and vibegron is one of 34 pro­grams in the “vant” clin­ic.

Urovant in-li­censed the glob­al rights, in­clud­ing Japan, to vibegron — an oral be­ta-3 adren­er­gic ag­o­nist — from Mer­ck $MRK. Vibegron is al­so be­ing test­ed for the treat­ment of OAB in men with be­nign pro­sta­t­ic hy­per­pla­sia and the treat­ment of pain as­so­ci­at­ed with ir­ri­ta­ble bow­el syn­drome. Mean­while, Urovant’s sec­ond ex­per­i­men­tal treat­ment, hMaxi-K, is a gene ther­a­py for pa­tients with OAB symp­toms who have failed oral phar­ma­co­log­ic ther­a­py.

Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.