Big pharma heads towards important readouts

Clinical data are expected soon from Novo Nordisk, Bayer and Sanofi, while Roche and Gilead take aim at ulcerative colitis.

Company events

As the battle against Covid-19 continues various clinical programmes have been disrupted, but big data readouts are still in play for some of those that started before the pandemic hit. Here, Evaluate Vantage delves into the important events due in the next couple of months for the major pharma players.

First up is Novo Nordisk’s semaglutide, which recently yielded encouraging mid-stage results in Nash. The group hopes to add another string to the GLP-1 agonist's bow, this time in obesity. Data from three late-stage studies in the Step programme are expected around the middle of the year.

A first look at efficacy, released last week, was impressive. In the Step 4 study patients achieved a total weight loss of 17.4% after 68 weeks. For comparison Novo's older GLP-1 agonist, marketed in obesity as Saxenda, is associated with 5-7% weight loss.

One of the company’s biggest hopes at increasing weight loss even further is AM833, an amylin analogue. A phase II dose-ranging study is expected to report soon, and Saxenda is used as an active comparator. According to the company a combination of AM833 with semaglutide could generate weight loss of at least 25%, and an early combination study will report later in the year.

Meanwhile, Bayer’s finerenone looks to be entering a narrowing opportunity in diabetic kidney disease. SGLT2 inhibitors are establishing a beneficial class effect in the setting, and Johnson & Johnson’s Invokana was the first drug of this class to win approval last year.

Topline data from finerenone’s first phase III study are due this quarter, while a second trial should read out early next year. Bayer hopes that finerenone can reduce patients’ risk of kidney failure and cardiovascular death versus placebo, but the results will also be held up against Invokana, which showed a 32% reduction in the risk of end-stage kidney disease and 20-30% reduction in various cardiovascular events.

Inflammatory disease

In ulcerative colitis Roche’s dual-action anti-integrin antibody etrolizumab is in five phase III trials. Etrolizumab’s pivotal programme will need to show differentiation from the competition, Takeda’s Entyvio, which acts on just one integrin.

Etrolizumab is not just up against placebo: two studies use Humira as control, and one Remicade. However, being pitted against older anti-TNF agents could be a backward step as newer mechanisms are expected to dominate the market in the coming years. Abbvie’s Rinvoq, a Jak 1 inhibitor, is forecast to lead the market by 2026, according to EvaluatePharma consensus.

In a phase IIb/III study Rinvoq itself showed a statistically significant clinical remission of 20%, per the adapted Mayo score, at its highest dose versus placebo. Data from the two other phase III trials that make up Rinvoq’s pivotal programme in ulcerative colitis are expected in 2021 and 2022.

Another Jak 1 inhibitor, filgotinib, from Gilead and Galapagos, will also have to compete with Rinvoq. Topline data from the Selection1 study are due this quarter.

Rare disease

Sanofi hopes to defend its place against Amicus in Pompe’s disease, and has a pivotal avalglucosidase alfa trial reading out soon. The study, in treatment-naive patients with late-onset disease, pits avalglucosidase against Sanofi’s own treatment Myozyme/Lumizyme.

Myozyme, an enzyme-replacement therapy, has been on the market since 2006 and is the only approved treatment for the rare disease. Forecasts for sales of this product reach $1.3bn by 2026, according to EvaluatePharma sellside consensus.

Forecasts for avalglucosidase alfa sit at $82m in 2026 but could rise if data impress. Myozyme’s own approval was based on two small trials where it showed improvement on ventilator-free survival in patients with infantile-onset disease versus an untreated historical control.

Competition is on the horizon in the form of Amicus's enzyme-replacement therapy AT-GAA. A rolling BLA submission for this project in late-onset Pompe’s disease is to begin in the second half of 2020. Phase III data from the Propel study, needed to support full approval, are expected next year; AT-GAA has 2026 forecasts of $637m.

The table below shows additional second-quarter events.

Selected Q2 clinical catalysts for big pharma (excludes Covid-19 data)
Project Company  Therapy area 2026e indication sales ($m) Q2 clinical catalyst Evaluate Vantage note/story link
Ozempic (semaglutide) Novo Nordisk Obesity 1,747

Step programme (Step 1, 2, 3, 4 reported). Phase II AM833 data NCT03856047

Will Novo’s big thinking in obesity pay off?
Etrolizumab Roche Ulcerative colitis 891 Phase III vs Humira (Hibiscis I, and II), vs Remicade (Gardenia), vs placebo (Laurel, Hickory) Roche’s test of novel gut target nears
Ipatasertib Roche mCRPC 476 Phase III Ipatential-150 (Zytiga combo vs Zytiga) Ipatasertib can cause diarrhoea, so clinical benefit gained will need to justify additional tox
Finerenone Bayer Diabetic kidney disease 380 Phase III Fidelio-DKD Bayer’s big kidney disease readout approaches
Filgotinib Gilead/ Galapagos Ulcerative colitis 127 Phase IIb/III Selection1 Upcoming events – Filgotinib's ulcerative colitis data and serlopitant takes on pruritus
Avalglucosidase alfa Sanofi Late-onset Pompe disease 82 Pivotal Comet See text
Rinvoq Abbvie Atopic dermatitis - Phase III Measure Up 1, NCT03607422 Data due mid year; Heads Up trial vs Dupixent has Sep primary completion date
mCRPC=metastatic castration-resistant prostate cancer. Source: EvaluatePharma sales by indication data; company releases; analyst notes;

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