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Text |Amino observations.No one will doubt that ** medicine will continue to create myths.
In 2023, the semaglutide weight loss version Wegovy, sales of 45US$4.8 billion, a year-on-year increase of 407%; The weight-loss version, Saxenda, liraglutide, also achieved sales of 14$9.3 billion.
With the gradual alleviation of the production capacity problem, the sales of "* medicine" will continue to rise.
The public's desire for beauty has created a trend of first-class medicine, and it has also given birth to a number of biotech that hope to become subversives. Overseas, Fractyl Health, the third biotechnology company to IPO this year, is a careerist who hopes to become a disruptor in the field of first-class drugs.
However, Fractyl Health looked unlucky, with its stock price plummeting 1433%, becoming the first stock to be issued on the first day of listing in the biotechnology field in 2024.
This does not mean that the *** of Fractyl Health is not promising. However, whether the ideal can be turned into reality is a question that all biotech needs to answer.
From an objective point of view, the R&D of innovative drugs is a concept of "mystery and mystery", and there are many uncertainties. Perhaps, the example of Fractyl Health is also reminding the market that while chasing the best drug outlet, the industry and the market also need to remain rational.
Founded in 2010, Fractyl Health is focused on pioneering new solutions for metabolic diseases, including diabetes and obesity.
Fractyl Health believes that the current hot ** drug market is in an era of potency but not persistence.
Indeed, the fiery GLP-1RAS drugs have a "** effect" in obesity**, and once the drug is stopped, weight loss cannot be maintained for a long time.
In the Step 4 withdrawal trial of semaglutide, some participants switched to placebo and some continued semaglutide after 20 weeks of receiving semaglutide**
The results showed that participants in the semaglutide group who continued to use semaglutide had an estimated mean weight change of -7 from week 20 to week 689% compared to +6 for participants using placebo9%。
In July 2023, Eli Lilly's surmount test results, tirzepatide also showed a similar "** effect".
This means that there is a large economic burden on the society. After all, neither semaglutide nor tirzepatide is cheap. In the U.S., the former's monthly** cost is more than $1,000.
not long-lasting", due to the fact that these drugs do not fundamentally solve the pathology of metabolism, so drugs that may need to be administered for a long time may be required.
Based on this, Fractyl Health believes that there are two things that need to be met in the future
First, the weight is maintained for a long time, at least more than one year; Second, it does not need to be sustained**, whether it is medication or surgery.
With this goal in mind, Fractyl Health has launched a combo.
Fractyl Health's first pipeline is a surgical** device, Revita, which aims to permanently alter duodenal dysfunction.
The duodenum is the first segment of the small intestine and the first part of the body where nutrients are absorbed. In general, the duodenal mucosa regulates the body's metabolic response to food intake.
However, due to long-term exposure to a modern diet high in fat and sugar, it leads to dysadaptation of duodenal stem cells and leads to dysfunctional hyperplasia of the duodenal mucosa.
In this case, the duodenal mucosa structure and function are altered, disrupting physiological nutrient perception and signaling mechanisms from the gut to the brain, leading to alterations in systemic metabolic activity, affecting glycemic control and satiety through multiple downstream organ systems.
To put it simply, duodenal dysfunction will enter a "negative feedback loop": high sugar and high oil affect the body's function, resulting in getting fatter and fatter; Getting fatter and fatter, further affecting the function.
There is currently no ** for the regeneration and renewal of the duodenal mucosa. So, Fractyl Health wants to solve this problem.
In the procedure, Revita first isolates the mucosa from the deep muscle layer of the duodenum and then performs a hydrothermal ablation of the superficial layer of the duodenal lining using a proprietary balloon catheter and console.
Within a few days after the ablation procedure, the duodenal mucosa regenerates and then rejuvenates the duodenal lining to better coordinate the intestinal metabolic signaling mechanisms.
In other words, Revita hopes to use thermal energy to ablate the dysfunctional duodenal mucosa, allowing the duodenum to regenerate and renew for long-lasting and reproducible metabolic improvements.
The second pipeline of Fractyl Health is the gene that targets the gen.
As mentioned above, although the GLP-1 drug currently on the market has a strong weight loss effect, it needs to be used continuously, and there may be a "** risk" once the drug is stopped, while gene ** has the potential to solve the problem of obesity more effectively and durably through a single dose.
Fractyl Health has developed GLP-1 PGTX, a gene candidate for GLP-1 based on the Rejuva platform.
This drug helps patients permanently produce their own GLP-1 agonists by using an inactivated adeno-associated virus to deliver a gene that stimulates GLP-1 expression in pancreatic cells, which leads to insulin release.
In preclinical trials, GLP-1 PGTX has also shown preliminary results superior to semaglutide. On October 4 last year, at the annual meeting of the European Association for the Study of Diabetes, Fractyl Health presented the results of the preclinical study of Rejuva.
The results showed that in a rodent model of diet-induced obesity, GLP-1 PGTX resulted in a 27% reduction in total body weight after a single dose of 28 days, compared with only a 21% reduction in body weight in the control group treated with a GLP-1 receptor agonist.
Moreover, GLP-1 PGTX has also shown long-lasting results. On the 29th day, both the experimental group and the control group were discontinued, and the body weight was continued to be measured on the 57th day.
The results showed that the weight of the animals in the GLP-1 receptor agonist group basically returned to normal; However, the GLP-1 PGTX group still maintained a similar weight loss level for 28 days. That is, the GLP-1 PGTX is more competitive.
Of course, winning in preclinical trials doesn't tell the story, and more time and data will be needed to prove itself in the future.
Although the weight loss story is perfect, Fractyl Health did not perform a miracle, but became the first stock to break on the first day of listing in the biotech field in 2024.
The core reasons lie in two points: first, Revita looks good, but it is still unknown whether it can be successfully launched and accepted by doctors and patients; Second, the gene is still in the preclinical stage, and the risk is very high.
Because of this, secondary market investors are more cautious. For innovative pharmaceutical companies, the only goal is to prove themselves through clinical data and sales performance. There's still a long way to go for Fractyl Health.