Rac­ing to grab mar­ket share in di­a­betes, No­vo touts its oral semaglu­tide win over Jar­diance in PhI­I­Ia tri­al

No­vo Nordisk’s oral di­a­betes drug semaglu­tide is bear­ing down on one of its ri­vals — out­per­form­ing Jar­diance (em­pagliflozin) in a Phase II­Ia tri­al that could set No­vo up to snatch more of the type 2 di­a­betes mar­ket.

Semaglu­tide, first ap­proved as an in­jectable by the FDA late last year un­der the brand name Ozem­pic, falls in the block­buster class of drugs known as GLP-1s. This lat­est tri­al, called Pi­o­neer 2, put an oral ver­sion of the drug up against Boehringer In­gel­heim and Eli Lil­ly’s Jar­diance, an oral SGLT2-in­hibitor ap­proved back in late 2016. The study pri­mar­i­ly looked at how No­vo’s pill com­pared at in­flu­enc­ing lev­els of gly­cat­ed haemo­glo­bin (HbA1c), an im­por­tant mea­sure for drug­mak­ers hop­ing to low­er the risk of heart fail­ure and oth­er com­pli­ca­tions as­so­ci­at­ed with high blood sug­ar over time.

The 52-week, open la­bel tri­al test­ed 14 mg of No­vo’s drug semaglu­tide com­pared with 25 mg of em­pagliflozin in 816 peo­ple with type 2 di­a­betes. The tri­al nailed its pri­ma­ry end­point, with semaglu­tide demon­strat­ing a sta­tis­ti­cal­ly sig­nif­i­cant and su­pe­ri­or im­prove­ment in HbA1c com­pared to em­pagliflozin. No­vo made a point to note that they mea­sured the da­ta in two ways: (1) a pri­ma­ry sta­tis­ti­cal ap­proach (re­quired by reg­u­la­tors) that eval­u­at­ed the drug’s ef­fect re­gard­less of whether pa­tients dis­con­tin­ued the treat­ment or had to use “res­cue” med­ica­tions” dur­ing the tri­al; (2) de­scrib­ing the ef­fect while on treat­ment and with­out the use of res­cue meds.

When mea­sur­ing the da­ta the pri­ma­ry way, the drug failed to hit one of its sec­ondary out­comes: weight loss, a new mar­ket op­por­tu­ni­ty No­vo hoped to tap. But when ap­ply­ing their sec­ondary ap­proach to analy­sis, No­vo re­port­ed the 14 mg dose demon­strat­ed weight loss of 4.7 kg at 52 weeks com­pared to 3.8 kg when on em­pagliflozin for the same pe­ri­od.

Mads Krogs­gaard Thom­sen

Al­so when ap­ply­ing the sec­ondary sta­tis­ti­cal ap­proach, 72% of peo­ple treat­ed with semaglu­tide hit the Amer­i­can Di­a­betes As­so­ci­a­tion tar­get of HbA1c be­low 7% , while on­ly 47% of pa­tients on em­pagliflozin hit this tar­get.

In the tri­al, oral semaglu­tide was well-tol­er­at­ed and had a safe­ty pro­file con­sis­tent with GLP-1-based ther­a­py. No­tably, though, the pro­por­tion of pa­tients who quit treat­ment due to ad­verse events was 11% on semaglu­tide, com­pared with on­ly 4% on em­pagliflozin.

“Pi­o­neer 2 is an im­por­tant mile­stone in the clin­i­cal de­vel­op­ment of oral semaglu­tide and we look for­ward to fur­ther un­der­stand­ing the clin­i­cal pro­file of oral semaglu­tide in the re­main­ing Pi­o­neer tri­als,” Mads Krogs­gaard Thom­sen, No­vo’s chief sci­ence of­fi­cer, said in a state­ment.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

FDA pan­el large­ly op­pos­es ex­pand­ing use of Lil­ly, Boehringer's SGLT2 in­hibitor to type 1 di­a­bet­ics

Last week, Eli Lilly and partner Boehringer Ingelheim rejigged the terms of their 2011 diabetes pact that nurtured the development of their blockbuster Jardiance franchise. Akin to manufacturers of rival SGLT2 drugs, the companies are working to expanding the use of their type II diabetes drug to reach a broader group of patients. On Wednesday, an expert panel to the FDA resisted that effort by largely voting against their quest to market the drug in type 1 diabetics.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

Amir Nashat, World Medical Innovation Forum via Youtube

Bay­er bets up to $100M on ex­plor­ing new bio­mol­e­c­u­lar con­den­sate ter­rain with a biotech up­start

In the Indiana Jones warehouse of genomic oddities, the millions of units of so-called “junk DNA” that create nothing but play a hand in tons of things have grabbed most of the attention. But there are other arks and Templar crosses out there.

Among them: the code for intrinsically disordered regions. Floating like boundless clumps of boiling spaghetti throughout the cell, these regions first appeared in scientific sketches at the turn of the century before vanishing from most cell diagrams, such as those in a high school textbook. Most organelles were neatly bound in membranes. These loose molecules resisted characterization. Scientists largely ignored them.

“I’m honestly embarrassed I didn’t notice them,” Phil Sharp, a Nobel Prize-biologist at MIT who co-discovered RNA splicing, told Endpoints News. 

In 2009, two researchers at the Max Planck Institute re-sparked interest in these regions and their code with a Science paper identifying them as “condensates.” They started a chain of discoveries that began to show them as using a concept called phase transition and playing a vital role in gene transcription and a host of cell functions. Cell diseases too. Derek Lowe got interested. So did Merck’s Jason Imbriglio. Now the most prominent biotech trying to leverage the still-young research for research, Dewpoint Therapeutics, is getting a deal worth up to $100 million to collaborate with Bayer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

In­vestors could emerge from Neil Wood­ford de­ba­cle with £1B loss, in­ter­nal analy­sis re­veals

When Link Fund Solutions announced that it is closing Woodford Equity Income Fund permanently and kicking out Neil Woodford, it was implied that investors probably won’t get back everything they entrusted to the fund manager. But nobody knew just how much they would lose.

An internal analysis commissioned by Link suggested that the collective loss could amount to £1 billion — out of a fund last valued at £3.1 billion — Citywire has revealed.

Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.
Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

FDA Vas­cepa re­view spot­lights new safe­ty sig­nals, pos­si­ble min­er­al oil spoil­er as Amarin hunts a block­buster ap­proval

An in-house FDA review of Amarin’s Vascepa raises a set of hurdles the biotech will have to clear if the biotech expects to get the long-awaited FDA approval that could set it on a path to superstar status. But it appears that Amarin has survived another potential setback without introducing a major new threat to its prospects.

The stakes don’t get much higher, with analysts saying a win this week for Amarin could lead to billions in new sales — provided the agency stamps it with an OK. And investors liked what they say in the FDA review this morning, bumping the stock $AMRN 17%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 65,400+ biopharma pros reading Endpoints daily — and it's free.

FDA slaps a hold on an AML tri­al as Mark­er scraps a fail­ing ovar­i­an can­cer pro­gram, sink­ing shares

The FDA has placed a hold on a Phase II AML trial from the small immuno-oncology biotech Marker Therapeutics. Marker disclosed the issue two weeks after responding to FDA concerns, adding it to the Q3 release Tuesday. The company also announced it was scrapping a Phase II ovarian cancer program it determined was unlikely to succeed.

The agency’s concern centers around two reagents used in manufacturing for their trial for acute myeloid leukemia patients who have received a stem cell transplant. The reagents are from third parties and not present in the final product, Marker said.