Ionis announces AstraZeneca’s initiation of the Phase 2b clinical study of its antisense medicine targeting PCSK9 to lower LDL-cholesterol

CARLSBAD, Calif., Nov. 30, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that the biopharmaceutical company AstraZeneca has initiated a Phase 2b clinical trial of ION449 (AZD8233), an investigational antisense medicine designed to reduce blood cholesterol levels in patients with dyslipidemia by targeting proprotein convertase subtilisin/kexin type 9 (PCSK9), an important regulator of low-density lipoprotein cholesterol (LDL-C). PCSK9 is an enzyme that controls the number of LDL receptors on the surface of cells. People with genetic variations that reduce PCSK9 function have lower LDL-C levels in the blood and a lower risk for major cardiovascular events. ION449 is a LIgand Conjugated Antisense (LICA) medicine being developed by AstraZeneca as part of a collaboration between Ionis and AstraZeneca.


(PRNewsfoto/Ionis Pharmaceuticals, Inc.)

The Phase 2b, randomized, double-blind, placebo-controlled trial will enroll approximately 108 participants, aged 18-75, who have LDL-C levels between 70 and 190 mg/dL and are receiving moderate- or high-intensity statin therapy as defined by the American College of Cardiology/American Heart Association (ACC/AHA) guidelines on blood cholesterol management. The primary objective is to assess the effect of different doses of ION449 on LDL-C compared to placebo at Week 12 in patients taking baseline statin therapy.  The study will evaluate three dose levels of ION449 versus placebo, all administered once a month by subcutaneous injection. Safety and tolerability will be evaluated along with a number of secondary endpoints. Learn more about the trial at: https://clinicaltrials.gov/ct2/show/NCT04641299. 

In a Phase 1 study reported at the American Heart Association (AHA) Scientific Sessions on November 13, single subcutaneous doses of ION449 (AZD8233) demonstrated dose-dependent mean reductions in circulating plasma PCSK9 and LDL-C levels of >90 percent and up to 70 percent, respectively, in subjects who had a baseline LDL-C between 100 and 190 mg/dL without concomitant statin therapy.Doses up to 120 mg were evaluated. ION449 was observed to be safe and well-tolerated at all dose levels. 

“Results from the Phase 1 study showed that ION449 potently reduces PCSK9 and LDL cholesterol. ION449 demonstrated best-in-class potential for PCSK9 inhibition and LDL-C reduction, supporting larger clinical trials that are now underway to further evaluate efficacy and safety,” said Sotirios “Sam” Tsimikas, M.D., senior vice president, clinical development and cardiovascular franchise leader at Ionis. “The growing evidence supporting Ionis’ advanced LICA technology in cardiovascular disease holds promise for more effective approaches to lower LDL-C and to address cardiovascular disease, the leading cause of death worldwide.”

Dr. Tsimikas will provide an update on Ionis’ cardiovascular programs during Ionis’ Virtual Investor Day, Dec. 7, 2020, beginning at 12 p.m. EST.

Ionis earned a milestone payment of $20 million from AstraZeneca for the Phase 2b clinical trial initiation of ION449. Ionis and AstraZeneca are collaborating on potential treatments for kidney disease, cardiometabolic disease and cancer.

About Ionis Pharmaceuticals, Inc.

As the leader in RNA-targeted drug discovery and development, Ionis has created an efficient, broadly applicable, drug discovery platform called antisense technology that can treat diseases where no other therapeutic approaches have proven effective. Our drug

Read more

Bowflex Energizes Its Targeting To Reach New Audiences Hungry For Home Fitness

Becky Alseth, VP of marketing and direct at Nautilus

When gyms closed during the lockdowns, demand for at-home exercise equipment increased.

Nautilus, which owns a portfolio of home gym brands, including Bowflex and Schwinn Fitness, experienced a nearly 94% increase in net sales in Q2.

“It was one of our best quarters ever,” said Becky Alseth, VP of marketing and direct at Nautilus.

In August, the company launched a new bike called the Bowflex VeloCore which includes a leaning mode option that simulates the feeling of cycling outside. Built into the experience is a membership-only workout app called JRNY that creates personalized workouts based on a cyclist’s preferences, fitness level and even mood.

“We’ve started to pivot from a physical equipment company only into a hardware and software company,” Alseth said.

The launch campaign to promote the VeloCore featured ad spots shot in New Jersey with instructions shared remotely live over Zoom by Bowflex’s creative director from his home office in Vancouver, Washington.

AdExchanger spoke with Alseth, whose exercise routine includes a three-mile walk at 6 am around her neighborhood in Montana.

AdExchanger: What’s your targeting strategy for Bowflex?

BECKY ALSETH: Bowflex has been in home fitness for more than 30 years, and for the past 10 or so we’ve been very focused on people who are just starting out on their fitness journey, whether that’s to deal with a health problem, for example, or because they simply haven’t been very active in the past.

Although we’re going to stick with our current customers, we also recently did a segmentation study to learn about a new type of customer, which is people who already love working out.

What did you learn during the study?

The segmentation that we’ve done is attitudinal as opposed to demographic. People usually want to go to the gym or take fitness classes away from home for multiple reasons. Maybe they don’t have the space, they don’t have the motivation or they want to exercise with friends and be with a community.

We’re finding that people of all ages and demographics go to the gym, but when COVID happened, more and more people began seeking out home fitness as an alternative.

What are the main ingredients in your marketing mix?

Historically, we spent a lot of money on direct response TV. Over the past couple of years, though, we’ve been shifting to a more balanced mix. We still do TV for brand awareness, but now we also do a lot of search, social and digital, including video and pre-roll, and we especially focus on PR and product reviews.

Home fitness is a fairly complicated category to shop and people often don’t know what a good piece of equipment should cost or what they’re getting for their money. That’s why we’re really getting into reviews, because we want to stay in the consumer’s consideration set as they make their decision. It could be a 60-day cycle between when someone decides to buy home fitness equipment and when they actually make the purchase.

How do you approach

Read more