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  #1   ^
Old Fri, Jul-19-24, 08:10
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Default Roche Obesity Pill Achieves Positive Results in Early-Stage Trial

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Roche Obesity Pill Achieves Positive Results in Early-Stage Trial

The Swiss company said the drug showed clinically meaningful weight loss of 7.3% after four weeks of treatment


Roche Holding said a new weight-loss pill under development achieved positive results in an early-stage clinical trial, bolstering the company’s efforts to enter the booming obesity market after another of its drugs showed weight-loss efficacy in May.

The Swiss pharmaceutical company is trying to get a slice of the market for drugs to treat obesity and diabetes currently dominated by Novo Nordisk and Eli Lilly. It entered the race through its $3 billion-plus purchase of Carmot Therapeutics, which gave Roche access to both oral and injectable drug candidates.

Roche said one of the experimental drugs it acquired through the Carmot deal—an orally administered drug called CT-996 which is being developed to treat both type 2 diabetes and obesity—showed clinically meaningful weight loss after four weeks of treatment in a Phase 1 study.

The oral drug is a more cost effective option for the company to develop, but in an increasingly-crowded obesity market Roche is eyeing combination therapies that could see patients transition from an injectable treatment to an oral form which might help maintain weight-loss, Manu Chakravarthy, Roche’s Head of Product Development for Cardiovascular, Renal and Metabolic, said in an interview.

He said that by taking a broader approach to managing weight, the company hopes to appeal to a larger target population of overweight patients rather than by only addressing the needs of people with obesity.

Although Phase 1 trials are only early-stage tests, the data are encouraging and suggest a competitive profile, Jefferies analysts said in a note to clients. More details and data from a wider patient population will likely be needed, while gastrointestinal side effects will also be scrutinized, they said.

Still, investors are keen to reward companies that show even early potential in an obesity market that analysts say could be worth well north of $100 billion in annual sales. The blockbuster success of Novo Nordisk’s Wegovy weight-loss drug has seen demand far outstrip supply and sent the Danish firm’s valuation soaring to become Europe’s most valuable company with a stock market valuation above that of the GDP of Denmark.

Roche shares traded 6.7% higher in afternoon European trade. Bryan Garnier Research analyst Bruno Bulic said the price move showcases the potential of the obesity market, as similar share reactions are typically only seen with positive late-stage trial data in the pharmaceutical industry.

Like Novo Nordisk’s Wegovy, CT-996 works by mimicking a gut hormone known as GLP-1 to control blood sugar and suppress appetite. The safety and tolerability profile of the drug was consistent with other oral drugs of the same class and no unexpected safety signals were observed, the company said. The trial had only a few moderate nausea cases, no severe cases and no discontinuation of patients, Chakravarthy said.

The trial showed the once-daily drug helped patients lose 7.3% of their body weight within four weeks, versus weight loss of 1.2% in a placebo group, and results appeared unaffected by fasting or after high-fat meals—unlike some of its peers, Roche said.

At first look, the results are better than efficacy profiles reported by Novo Nordisk’s injectable Wegovy and Eli Lilly’s injectable Mounjaro, which both indicate 2%-4% weight loss at four weeks, Bryan Garnier Research analysts Bruno Bulic, Maria Vara and Oscar Haffen Lamm said in a note to clients.

A late stage trial by Novo Nordisk of its high-dose oral semaglutide drug last year showed weight loss of 15% after 68 weeks, but that was achieved alongside diet and physical activity.

Meanwhile, a Phase 1 trial of Novo Nordisk’s next generation amycretin weight-loss pill showed weight loss of around 13% after 12 weeks, better than the 6% weight loss patients experienced after 12 weeks in a trial of its blockbuster Wegovy drug.

Eli Lilly’s orforglipron obesity pill has shown weight loss of 15% after 36 weeks in a Phase 2 trial, with late-stage data expected next year.

Companies such as Pfizer, AstraZeneca and Viking Therapeutics are also developing oral GLP-1 weight-loss drugs but Roche’s Chakravarthy said the competition shouldn’t be viewed as a threat but as an indication of a vast unmet need to lower mortality rates. “Even if we have 10 drugs on the market, it would still not be enough,” he said.

The company aims to release further data on its weight loss pill candidate in patients with obesity and type 2 diabetes in the next months and targets a phase 2 trial next year, Chakravarthy said.

Roche’s CT-996 is the second experimental obesity drug to achieve positive results in an early-stage trial. In May, the company said another drug candidate, CT-388, which is administered via an injection, demonstrated efficacy in a Phase 1 study, by leading to significant weight loss in healthy adults with obesity compared to placebo.


https://www.wsj.com/health/pharma/r...ealth_lead_pos2
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  #2   ^
Old Sat, Jul-20-24, 12:09
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Calianna Calianna is offline
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The trial showed the once-daily drug helped patients lose 7.3% of their body weight within four weeks, versus weight loss of 1.2% in a placebo group, and results appeared unaffected by fasting or after high-fat meals—unlike some of its peers, Roche said.

At first look, the results are better than efficacy profiles reported by Novo Nordisk’s injectable Wegovy and Eli Lilly’s injectable Mounjaro, which both indicate 2%-4% weight loss at four weeks, Bryan Garnier Research analysts Bruno Bulic, Maria Vara and Oscar Haffen Lamm said in a note to clients.

A late stage trial by Novo Nordisk of its high-dose oral semaglutide drug last year showed weight loss of 15% after 68 weeks, but that was achieved alongside diet and physical activity.

Meanwhile, a Phase 1 trial of Novo Nordisk’s next generation amycretin weight-loss pill showed weight loss of around 13% after 12 weeks, better than the 6% weight loss patients experienced after 12 weeks in a trial of its blockbuster Wegovy drug.

Eli Lilly’s orforglipron obesity pill has shown weight loss of 15% after 36 weeks in a Phase 2 trial, with late-stage data expected next year.


At first glance, I thought the 7.3% weight loss in 4 weeks sounded dangerously fast. But then I thought about how people new to LC/Keto can lose that much the first week or two - most of it fluid of course.

The question is whether or not the people on those drugs are losing mostly excess fluid those first few weeks, or if it's primarily fat loss.

How much muscle and bone mass is being lost during those few weeks? Is anyone even questioning that?

The rest of those stats are not all that much different from the losses you'd get from most diets. Since we're taking about obese individuals taking these drugs, lets use a hypothetical starting weight of 200 lbs:

4 weeks on oral drug (Roche):
7.3% would be 200-14.6=185.4 lbs or average of 3.65 lbs/week

4 weeks on injected drug (Novo Nordisk and Eli Lilly):
2 % would be 200-4=196 or average of 1 lb/week
4% would be 200-8=192 or average of 2 lbs/week

_______

12 weeks on oral drug (Novo Nordisk):
13% would be 200-26=174 or average of 2.16 lbs/week

12 weeks on injected drug (Novo Nordisk):
6% would be 200-12 = 188 or average of 1 lb/week

_________

36 weeks on oral drug (Eli Lilly):
15% would be 200-30=170 or average of 0.83 lbs/week

________

68 weeks on oral drug, plus exercise and modified diet (Novo Nordisk):
15% would be 200-30=170 or average of 0.44 lbs/week

I separated them by number of weeks so that it's easier to see the comparison between different drugs.

When you break it down like that, other than the 2% and 4% stats after 4 weeks on the injected drugs, it doesn't look all that different from the average weight loss expected from most calorie based plans after the indicated number of weeks. Weight loss on most diets will start out fast, and as your body adjusts to the reduced caloric intake, weight loss slows down to 1/2 to 1-1/2 lb/week on average.

Even on LC there's generally a quick loss of excess fluid the first week or two, then it also slows down to an average of about 1/2 to 1-1/2 lb/week.

It would be interesting to see the stats for each brand of drug at the same number of weeks - all of them at 4 weeks, 12 weeks, 36 weeks and 68 weeks.

But if the 68 week stats on the Eli Lilly oral drug is anything to go by, chances are the Roche and Novo Nordisk oral drugs will slow down considerably and have similar results after that many weeks.

So the real concern is still what these drugs are actually doing to the ones who use them.... and of course once they reach a goal weight, are they going to be able to maintain their weight loss without the drug?
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  #3   ^
Old Sat, Jul-20-24, 15:50
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We never see body fat composition in these obesity drug studies.
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  #4   ^
Old Sat, Jul-20-24, 18:33
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Calianna Calianna is offline
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Originally Posted by WereBear
We never see body fat composition in these obesity drug studies.


Yes- that's another thing. Losing excessive amounts of lean body mass is only going to make things worse.

We also don't see their starting weights - they could all be just barely into the obese category, or they could all be 500+ lbs. Or any random number of weights.

They could have all lost different percentages of their start weight and we're only seeing an average based on vastly different percentages lost. Or they could have all lost approximately the same percentage of their start weight, but vastly different poundage.
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  #5   ^
Old Sun, Jul-21-24, 06:31
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The race to develop the ‘holy grail’ of weight-loss drugs

Fear of jabs has companies scrambling to be the first to launch a mass-market obesity pill


When Ian Strachan first started informing patients of how to secure weight-loss drugs at his pharmacies, he quickly realised that demand was strongest among one particular group.

“It was basically 50 and 60-year old women,” says Strachan, who runs a cluster of pharmacies in the north of England.

“They’d heard about the obesity injections through shows like Loose Women so they had a general idea about how they worked.”

Many of them viewed the treatments as a lifeline after years of struggling to shift the pounds. “They had tried everything,” says Strachan. “What they needed was a magic bullet.”

There was, however, one obvious deterrent. Despite Novo Nordisk’s Wegovy or Eli Lilly’s Mounjaro helping people lose between 15pc and 22.5pc of their body weight, some patients were steering clear of the drugs out of fear of weekly injections.

Now, optimism is growing that this barrier will be removed by the introduction of once-daily weight-loss pills and the surging investment for developing them.

While Novo Nordisk and Eli Lilly have dominated the weight-loss drug market with their existing jabs, experts believe more lucrative opportunities lie ahead with pills.

Up until now there has been limited progress on oral options, with companies struggling with a shortage of ingredients such as semaglutide.

However, if executives are able to roll out the treatment more broadly, mass market demand is expected to soar.

“The orals will play a very significant role,” said Pfizer chief executive Dr Albert Bourla last September. “Not everybody likes injections.”

Estimates suggest around a 10th of people are afraid of needles, although drug bosses believe the introduction of pills will hoover up far more customers than that. According to AstraZeneca chief Sir Pascal Soriot, at least 75pc of people would prefer to take pills over injections.

The British drugmaker is among a flurry of businesses racing to seize a slice of the market, alongside global giants including Pfizer, Roche and Boehringer Ingelheim, as well as biotechs such as Viking Therapeutics.

According to figures from industry group Airfinity, around 230 weight-loss drugs are currently progressing through studies and trials. A substantial chunk of these are thought to be oral pills. While many of these trials are in the very early stages, some companies are within shooting distance of bringing their pills to market.

Eli Lilly is among the frontrunners, having recently moved its experimental weight-loss pill into the last stage of clinical tests. Findings suggest the pill – which could also be taken with food – could help people lose an average of 24pc of their body weight.

However, it will not just come down to who is quickest to market.

Emily Field, an analyst from Barclays, says rivals will still be able to gain traction despite the head start secured by Novo Nordisk and Eli Lilly.

“That doesn’t mean companies like Roche and AstraZeneca can’t also have multibillion-dollar products,” she says. “Because the numbers are just so big.”

Goldman Sachs estimates that the weight-loss treatment industry will be worth around $130bn (£100bn) a year by 2030.

Others suggest it could end up being a similar market to female contraception, where patients ultimately work out which treatment is best for them.

Investors seem to be hedging their bets, as they back a range of different companies.

For years, Eli Lilly and Novo Nordisk have enjoyed eye-watering rallies in their share price – up 157pc and 122pc respectively since mid-2022.

However, when Roche set out results from its early-stage clinical trial last week, showing its daily obesity pill led to weight loss of 7pc in four weeks, shares jumped to their highest level in the past year.

Field says there is a clear sense of “obesity momentum” in the markets.

“I was talking to investors and they were saying, ‘I don’t like Roche, I don’t think Roche is that good a stock, but you have to own it because you can’t fight this momentum’. You’ve just got to get on the train or you’ll get run over.”

There is, equally, the argument that companies are developing better and better drugs, ones that help treat more than just people’s weight but also other conditions.

Zealand Pharma, which is working on weight-loss pills, said its focus is not purely on helping people shed more pounds.

Chief executive Adam Steensberg told the Financial Times that the plan was to design treatments with “similar degrees of weight loss but the potential to better address specific [illnesses that occur with] obesity”.

Meanwhile, AstraZeneca has suggested it is planning to use its weight-loss pill in combination with its other medicines to help people not just lose weight but also tackle things like cardiometabolic diseases.

A crucial aspect of this will be price. AstraZeneca’s Sir Pascal said the aim was to make weight-loss pills cheaper than injections.

Professor Naveed Sattar, who was appointed to helm Britain’s obesity-cutting programme last year, said this could be a game-changer.

He is expecting the next generation of weight-loss pills to be “substantially cheaper” after taking into account the lower cost of storing pills and the fact manufacturers would not require needles.

“We need to wait until we have the data but there could be an argument in using these to help prevent people from developing obesity in the first place,” Sattar says. “It’s becoming much harder for people to lead healthier lives without some conscious effort.

“There’s more food around and the opportunities to be physically active are less given we have cars – so people are struggling.”

He hopes at least one or two pills are approved in the next five years: “It would really widen how much they can be used.”

It is a view shared by Strachan, who says the pill version could send demand for weight-loss drugs into overdrive.

“People are generally frustrated with not being able to lose weight,” Strachan says. “We are only at the tip of the iceberg.”

https://www.telegraph.co.uk/busines...ight-loss-pill/
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  #6   ^
Old Sun, Jul-21-24, 07:02
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Calianna Calianna is offline
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There is, equally, the argument that companies are developing better and better drugs, ones that help treat more than just people’s weight but also other conditions.

Zealand Pharma, which is working on weight-loss pills, said its focus is not purely on helping people shed more pounds.

Chief executive Adam Steensberg told the Financial Times that the plan was to design treatments with “similar degrees of weight loss but the potential to better address specific [illnesses that occur with] obesity”.



The GLP-1 drugs were originally developed to help diabetics have more blood sugar control. Losing weight on it was one of those "happy accidents", or an unexpected surprise.

We've been harangued for decades about how obesity is killing us - it's related to heart disease, cancer, diabetes,sleep apnea, back problems, joint issues, and on and on and on. It only makes sense that if losing weight on your own is the panacea that helps improve these conditions, then losing weight with the help of a drug would very likely also help all of these obesity related conditions.

Why do they now suddenly act as if it's a big surprise that the drugs could be used for more than "just losing weight", that losing weight on these drugs might actually have some other unexpected health benefits: improving conditions related to obesity, simply because they're causing weight loss.
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  #7   ^
Old Sun, Jul-21-24, 09:27
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WereBear WereBear is online now
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Originally Posted by Calianna
Why do they now suddenly act as if it's a big surprise that the drugs could be used for more than "just losing weight", that losing weight on these drugs might actually have some other unexpected health benefits: improving conditions related to obesity, simply because they're causing weight loss.


Because they rely on busy people having a short attention span.
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  #8   ^
Old Sat, Sep-14-24, 06:33
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Calianna Calianna is offline
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Viking Therapeutics: A Bad Result for Roche's Weight-Management Pill Is Great News for Oral VK2735

Weight-management treatments are all the rage lately. According to Morgan Stanley, combined sales of injections that curb appetites and promote weight loss could reach an estimated $105 billion by 2030.

Viking Therapeutics (NASDAQ: VKTX) is still a clinical-stage drugmaker that's developing an anti-obesity candidate called VK2735 that appears competitive with a similar drug the U.S. Food and Drug Administration (FDA) approved in 2022 called tirzepatide. Marketed by Eli Lilly as Mounjaro for diabetes and Zepbound for weight management, tirzepatide sales have already exceeded $17.3 billion annually.

Many potential consumers of weight-management drugs are holding off because they don't want to jab themselves with a needle each week. Providing an easy-to-swallow solution for these patients could lead to billions in annual revenue, but clinical development of oral anti-obesity drugs has been more than a little challenging.

Why Roche's oral weight-management drug probably isn't going anywhere

In July, Roche (OTC: RHHBY), a global pharmaceutical giant, reported positive efficacy results from a placebo-controlled phase 1 study with its oral weight-management candidate CT-996. After four weeks of treatment, patients randomized to receive the highest dosage of CT-996 reduced their weight by 6.1%, compared to a placebo.

In March, Viking Therapeutics showed us that an oral version of its weight-management candidate VK2735 led to a weight loss of 3.3%, on average, versus a placebo after one month. This doesn't compare well to CT-996, but getting patients to lose weight isn't the biggest challenge with oral weight-management candidates. So far, safety issues have been a much bigger concern.

When it comes to tolerability, it looks like CT-996 has a problem. The phase 1 trial randomized 19 patients to receive three different dosages of CT-996, and 16 reported nausea. Among 13 patients given the highest doses, seven reported vomiting, and seven reported indigestion.

None of the treatment-emergent events caused by CT-996 were serious enough to require hospitalization, but anti-obesity treatments are intended for relatively healthy people. Even if it isn't quite as effective, oral VK2735 appears much easier to tolerate, which bodes well for its future. Phase 1 results show just 4 out of 16 patients treated with the two highest doses reported mild nausea after a month of treatment, and none vomited.

What's next for Viking Therapeutics

So far, we've only seen CT-996 and VK2735 tested on very small groups of patients. A larger study could improve CT-996's outlook, but for now, it looks like Viking's candidate is best in class.

We could soon learn a lot more about oral VK2735. Viking Therapeutics is expected to present phase 1 data for higher doses at a conference in November. If a higher dosage can close the efficacy gap with CT-996 without raising the frequency of reported side effects, the stock could soar.

Investors new to Viking Therapeutics will be glad to learn that oral VK2735 isn't the only new drug candidate progressing through its development pipeline. The injected version could begin a phase 3 trial designed to support an application by the end of 2024. The FDA will most likely insist on at least a year of follow-up data, which means the pivotal study won't produce meaningful data until at least the middle of 2026.

In early 2025, Viking Therapeutics will likely begin a phase 3 trial with VK2809, an experimental treatment for metabolic dysfunction-associated steatohepatitis (MASH). This condition impairs the liver function of millions of Americans, but the FDA didn't approve the first MASH treatment Rezdiffra until this March.

Sales of Rezdiffra from Madrigal Pharmaceuticals are still ramping up. With millions of potential patients and just one treatment option available, VK2809 still has a great chance to achieve more than $1 billion in annual sales if eventually approved.


Is Viking Therapeutics stock a buy now?

Roche's misfortune with CT-996 improves the outlook for oral VK2735, but it doesn't make Viking Therapeutics a safe stock to buy. For starters, it's going to be over a year before Viking can send an application for its first drug to the FDA. The company is a long way from having a drug to sell, but the stock has a sky-high market cap of $7.1 billion at recent prices.

Viking Therapeutics finished June with a healthy $942 million in cash after burning through $51.5 million in the first half of 2024. Running big phase 3 trials for two candidates will push operating expenses a lot higher next year.

Viking Therapeutics probably has enough cash in its coffers to keep operations humming along until its lead candidates produce phase 3 data. If phase 3 results for VK2735 are anything but a rousing success, though, investors who buy at recent prices could get wiped out.

While I do expect success from VK2735, clinical-trial outcomes are never as predictable as investors want them to be. This stock is a buy for folks with a sky-high risk tolerance, but others should watch from a safe distance.
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https://finance.yahoo.com/news/viki...-075100849.html

I only included the investment related information to confirm just how much the development of weight loss drugs is linked to $$$$$$ - for the pharm companies as well as investors wanting to get in on something that could make them filthy rich.
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  #9   ^
Old Tue, Sep-17-24, 08:08
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WereBear WereBear is online now
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Originally Posted by Calianna
I only included the investment related information to confirm just how much the development of weight loss drugs is linked to $$$$$$ - for the pharm companies as well as investors wanting to get in on something that could make them filthy rich.


Who is going to admit there are ten giant food companies making addictive substances?

If everyone ate the way we do, the economy would crash. Because it's dependent on fads and idiocy, not actual "worth," seems to me.

The tobacco companies revamped themselves. They bought cookie companies and did the same things. That is what we are dealing with.
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