Structure Therapeutics: Potential To Have Best-In-Class GLP-1 Agonist For Obesity Patients

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Positive 12-week data from phase 2a study of GSBR-1290 targeting obesity patients; significant placebo adjusted mean weight loss of 6.2% & 6.9% achieved for capsule and tablet respectively.One analyst...

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significant placebo adjusted mean weight loss of 6.2% & 6.9% achieved for capsule and tablet respectively.One analyst...</p>\n\n<a href=\"https://seekingalpha.com/article/4728366-structure-potential-best-glp1-agonist-for-obesity-patients\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://seekingalpha.com/article/4728366-structure-potential-best-glp1-agonist-for-obesity-patients","article_id":"2477392609","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2477392609","pubTimestamp":1729620432,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Positive 12-week data from phase 2a study of GSBR-1290 targeting obesity patients; significant placebo adjusted mean weight loss of 6.2% & 6.9% achieved for capsule and tablet respectively.One analyst","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","GPCR":"STRUCTURE THERAPEUTICS INC SPON ADS EACH REP 3 ORD"},"translate_title":"Structure Therapeutics：为肥胖患者提供同类最佳GLP-1激动剂的潜力","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GPCR":0.9},"content_text":"Positive 12-week data from phase 2a study of GSBR-1290 targeting obesity patients; significant placebo adjusted mean weight loss of 6.2% & 6.9% achieved for capsule and tablet respectively.One analyst believes that the market for obesity treatments could expand to $200 billion by 2031.The 36-week phase 2b study, using GSBR-1290 for the treatment of patients with obesity, expected to start in Q4 of 2024.LTSE-2578 is being developed in phase 1 study targeting patients with idiopathic pulmonary fibrosis; the global idiopathic pulmonary fibrosis market is expected to reach $11.7 billion by 2031.Structure Therapeutics Inc. (NASDAQ:GPCR) was able to report positive results from its phase 2a study using its GLP-1R agonist GSBR-1290 for the treatment of patients with obesity in June 2024. This is an important outcome because it now leads to another milestone for investors to look forward to, which is the initiation of the 36-week phase 2b study using this drug to treat these patients in Q4 of 2024. The scope of this biotech though is its ability to achieve rapid weight loss in a short amount of time as I will be going over below. However, another item to note is that it was able to switch from its capsule formulation to a tablet formulation and achieve substantial once-daily dosing weight loss for these patients. Beyond this, the company is not going to take the chance of only developing this drug alone to achieve weight loss for these patients, it is also going to combine this GLP-1R agonist with other drugs from its pipeline like an APJR agonist ANPA-0073, GIPR selective agonist and amylin receptor agonist. The promise of this company is its ability to use other drugs for other indications from what I can see. Consider that ANPA-0073 is not only being developed to treat patients with obesity, but may also be used in treating patients with idiopathic pulmonary fibrosis [IPF]. Speaking of which, there actually even is another shot on goal in being able to target this large multibillion-dollar market indication. This is in regard to the development of LPA1R agonist LTSE-2578 for the treatment of patients with IPF as well. A phase 1 randomized study for this program was initiated in June 2024 and is ongoing. The best part of all is that it has enough cash to get through several milestones because it states that it is well-funded to operate its business through 2027. The reason is that back in June 2024, it enacted an offering bringing in a large amount of cash on hand. With the ability to advance GSBR-1290 into many combinations for obesity, plus the ability to move some drugs in the pipeline towards the other large market indication of IPF, I believe that investors could benefit from any potential gains made here. GSBR-1290 For The Treatment Of Patients With Obesity As I have stated above, Structure Therapeutics was able to report positive results from its phase 2a study using its GLP-1R agonist GSBR-1290 for the treatment of patients with obesity. The goal of this company is to provide an alternative to currently available injectable drugs of the very same class. However, by improving safety and even possibly efficacy as well. Before going over the phase 2a results released from the completed study using this drug to treat these patients, it is first important to go over what obesity is and what the possible market opportunity for it could be. Obesity is a type of disorder characterized by an excessive amount of body fat. Consider that these patients have a body mass index [BMI] of 30 or higher. It is a type of chronic disease that sometimes can be managed with a change in food habits plus exercise, but lately, these drugs are also added into this mix to help these patients. The thing is that obesity just needs to be treated somehow. Why is that? That's because if left untreated, then it could lead to a host of other disorders such as the following:  Type 2 Diabetes [T2D]. Gallstones [stones that get stuck in the bile ducts and/or liver]. Fatty liver disease [Such as MASH or metabolic dysfunction-associated steatohepatitis]. Diseased kidney.  One analyst believes that the market for obesity treatments could expand to $200 billion by 2031. This is a very large market opportunity, but the thing is that GLP-1R agonists are expected to take a huge chunk of it. New drugs such as GSBR-1290 that is highly selective small molecule may offer an edge over them, but this remains to be seen in further clinical testing. It may be able to do this because the company's technology platform developed this drug to selectively activate the G-protein signaling pathway. In order to see if the company would be capable of being able to treat these patients with obesity, it ran the phase 2a study which recruited patients with obesity and type 2 diabetes [T2D]. This 12-week double-blind, randomized controlled study recruited a total of 64 healthy or overweight patients and were then randomized to one of the following dose treatment groups as follows:  37 patients were given 120 mg of GSBR-1290 once daily. 27 patients were given a placebo once daily.  The final data released was highly positive, especially when you consider that in a short amount of time [12 weeks] patients were able to lose a significant amount of weight. It was revealed that in patients who took 120 mg of GSBR-1290 once daily, they achieved a significant placebo-adjusted mean weight loss percentage of 6.2%. This average weight loss during this period of the drug compared to placebo was achieved in a statistically significant manner, with a p-value of p<0.0001. The thing is that the percentage of weight loss achieved is competitive compared to other GLP-1R agonists approved or in clinical development. Why on earth does this company have a shot at potentially becoming the best-in-class GLP-1R agonist as an obesity treatment? Besides that, after only 12 weeks of competitive weight loss percentage, the low amount of safety events means that this company can explore higher dosing of GSBR-1290 in the upcoming phase 2b study. Not only does it have the ability to move to higher dosing, with its start low and go slow titration strategy, but it may almost have the benefit of providing patients with an oral drug option. Why is this crucial? That's because currently approved drugs such as Zepbound from Eli Lilly and Company (LLY) have to be given once weekly as an injectable type. I believe that when possible, an oral drug alternative will always be more welcomed than that of an injectable. Speaking of an oral drug, the company also added another portion of this phase 2a study. It added a capsule to tablet Pharmacokinetic [PK] study to see if moving to this kind of oral drug would end up being better. This was a good idea to test out and believe it or not, but it actually ended up working out. It was shown that the patients given the tablet formulation of GSBR-1290 were able to achieve a slightly higher placebo-adjusted mean weight loss of 6.9%, which also beat the placebo with a statistically significant p-value of p<0.0001. The only thing to note is that Adverse Event [AE] treatment discontinuations from the phase 2a portion of the study were 5%, but in the tablet PK study, it went up a bit to 11%. Still, there were no elevated liver enzymes found, thus the ability for the company to move to higher GSBR-1290 dosing in the upcoming phase 2b study for this program. Moving From GLP-1R Agonism For Obesity Patients To Combination Therapies The thing is that despite Structure Therapeutics having already reported data from the phase 2a study, using GSBR-1290 for the treatment of patients with obesity, there are still several catalysts for investors to look forward to. The first of which is the initiation of the 36-week phase 2b dose-range finding study using this very same GLP-1R agonist to target these obesity patients. Such a mid-stage trial is expected to begin in Q4 of 2024 and from there, data from it will be released in Q4 of 2025. Even better, if the primary endpoint of this 36-week phase 2b study is met with statistical significance, then it would put the initiation of a phase 3 study in 2026. The thing is that there are a host of other types of catalysts for investors to look forward to. For instance, the company is also in the process of developing other drugs in its pipeline to be used in combination with GSBR-1290 as follows:  Oral small molecule Amylin drug program. Oral small molecule GIPR drug program. ANPA-0073 oral small molecule APJR program. Oral small molecule GCGR program.  The thing is that several of these candidates being developed are also expected to be advanced in the clinic. Should each program turn out to be good on its own, then the end-game goal is to combine them together with GLP-1R agonists to increase the amount of weight loss that can be achieved compared to a single drug alone. The most notable one to go over would be the development of the Amylin inhibitor program because a candidate is expected to be nominated in Q4 of 2024. Upon this achievement, would then mean the initiation of a phase 1 study targeting obesity patients using an Amylin agonist drug in the 2nd half of 2025. Pipeline Much More Than Just Developing Drugs For Obesity Patients The thing is that while there are going to be multiple shots on goal in being able to target patients with obesity, there might be a way to capitalize on another large multibillion-dollar market opportunity. This would be with respect to the development of LTSE-2578 as an oral LPA1R agonist drug being developed for the treatment of patients with idiopathic pulmonary fibrosis. Before going over the advancements made thus far with this program, plus any possible catalysts to come about from it, it is first important to understand what this disorder is and what the possible market opportunity for it could be. Pulmonary Fibrosis is a type of disorder characterized by the lungs becoming scarred and/or damaged. The reason is that there is some kind of damage that causes the walls in the lungs to become thick and stiff. In turn, this means that the lungs can't carry oxygen throughout the body as they normally would. There are several symptoms that these patients with pulmonary fibrosis experience as follows:  Extreme fatigue. Unexpected weight loss. Muscles that hurt. Shortness of breath. Dry coughing.  It is then important to note how the term \"idiopathic\" comes into play here. The term idiopathic, in essence, means a disease arising with no known cause. Thus, a patient who has idiopathic pulmonary fibrosis has scarring/damage to the lungs with no known root cause. In essence, it just comes about randomly. The global idiopathic pulmonary fibrosis market is expected to reach $11.7 billion by 2031. This is another large market opportunity. This company hopes to be in a position to target these IPF patients with an LPA1R agonist drug known as LTSE-2578. This particular drug is specifically being developed to target these patients. A phase 1 study for this program was initiated in June 2024 and then clinical data from it is expected to be released in the 2nd half of 2025. This program is highly important because it is believed that Lysophosphatidic Acid Receptor 1 [LPA1] receptor agonism might be implicated in removing excess collagen with respect to lung fibrosis injury. Having said that, or to take it one step further, Bristol Myers Squibb Company (BMY) has not only established a mechanism of action [MOA] in using LPA1R agonism against IPF, but it is in the process of running two phase 3 studies. This clinical candidate goes by the name of BMS-986278, and it is currently being evaluated in the phase 3 ALOFT program. One phase 3 study is targeting patients with IPF and has a primary completion date of October 26th, 2026. The second phase 3 study being done would be using BMS-986278 for the treatment of patients with Progressive Pulmonary Fibrosis [PPF]. This one has an estimated primary completion date of December 27th, 2027. This program for this big pharma is coming along well, as it received FDA Breakthrough Therapy Designation from the FDA for this drug back in October 2023. The point here is that with the MOA proven, plus the ability to possibly develop a best-in-class LPA1R agonist for IPF patients, I believe this is another solid long-term program. The truth is that this is not the only shot on goal in targeting these specific patients because ANPA-0073 as an APJR agonist inhibitor is also being developed for the treatment of patients with IPF. A phase 1 single-ascending and multiple-ascending dose study, testing this drug out, showed that the drug was well-tolerated with no serious adverse events [SAEs]. Again, it may also have been used as a muscle-sparing weight-loss drug. Financials According to the 10-Q SEC Filing, Structure Therapeutics had cash, cash equivalents and short-term investments of $927.1 million as of June 30th of 2024. The reason for the cash on hand is that the company was able to close an upsized underwritten public offering of 10,427,017 American Depositary Shares [ADSs], each representing three ordinary shares, including the full exercise of the underwriters' option to purchase up to 1,360,045 additional ADSs with a public offering price of $52.50 per ADS. The total aggregate gross proceeds from this offering were $547.4 million. The company is now well capitalized to reach through several key clinical catalysts. Why is that? That's because it believes that it has enough cash on hand to fund its operations through at least 2027. Risks To Business There are several risks that investors should be aware of before investing in Structure Therapeutics. The first risk to consider would be with respect to the development of GSBR-1290 for the treatment of patients with obesity. A phase 2b study is expected to begin in Q4 of 2024 and there is no assurance that the data to eventually be released from it will turn out to be positive. Nor, that the results to be released will be good enough to move forward toward phase 3 clinical testing. The second risk to consider would be in terms of the possible combination therapies using the other drugs in its pipeline for the treatment of patients with obesity. As I noted directly above, there is an amylin inhibitor, GIPR inhibitor, and APJR inhibitor being developed alone at first. Should they pan out in initial phase 1 testing, then the goal would be to combine them with GLP-1 agonist GSBR-1290 to treat patients with obesity. The third risk to consider would be in terms of competition in the obesity space. For instance, you have a lot of drugs either approved in clinical development to target the obesity market. One major competitor to beat would be Eli Lilly with Zepbound, which will not be an easy task. Especially, when you consider that the MOA of this drug is dual targeting of GLP-1 and GIP agonism. However, the downside with some drugs is that they are injectables. Thus, the company may compete well against this and many other drugs if it can achieve a competitive weight loss percentage, but at the same time also offer an oral route of administration instead. The risk here is that there is no assurance that GSBR-1290 will be shown to be superior to that of Zepbound or any other obesity drugs. The fourth and final risk to consider would be in terms of developing an LPA1 receptor [LPA1R] agonist drug for the treatment of patients with IPF in the ongoing phase 1 study. The risk here is that there is no assurance that positive data will be achieved from this study for starters. Nor, that the results to be released will be enough to warrant further testing of this drug for the treatment of this patient population. In addition, while Bristol-Myers Squibb did establish the MOA of an LPA1 drug working in being able to treat these patients, there is no assurance that LTSE-2578 from Structure Therapeutics will do the same. Plus, you have to consider that Bristol-Myers Squibb's drug BMS-986278 might end up being a highly competitive drug if it is ultimately approved by regulatory authorities. Conclusion Structure Therapeutics has done well in developing its GLP-1R drug for the treatment of patients through the phase 2a study. As I have shown above, it has been able to achieve a substantial amount of weight loss with both GSBR-1290 given as a capsule or tablet for obese patients. This company is trying to make GLP-1 inhibition a more convenient option for these patients by giving them an oral alternative. Not only that, but the company hopes that it can get the drug out faster to patients. How so? Well, this would be through a more convenient manufacturing process. It believes that it can bring its process to scale to help >120 million patients. Plus, the fact that there is a huge safety window means that it can test out higher dosing in the next few studies. Again, it has several other drugs it is advancing individually to see if it can eventually combine them together with GSBR-1290 to achieve a greater weight-loss percentage for obese patients. It is also developing a few drugs to target patients with IPF as well, which are LTSE-2578 and ANPA-0073.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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