Viridian: Active TED Data Signifies Next Round Of Positive Data On The Way

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Viridian Therapeutics, Inc. reported that the primary endpoint was met for the phase 3 THRIVE study, using veligrotug for the treatment of patients with active thyroid eye disease.Data release for ...

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The Way\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-11 05:09 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4720284-viridian-active-ted-data-signifies-next-round-of-positive-data-on-the-way><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Viridian Therapeutics, Inc. reported that the primary endpoint was met for the phase 3 THRIVE study, using veligrotug for the treatment of patients with active thyroid eye disease.Data release for ...</p>\n\n<a href=\"https://seekingalpha.com/article/4720284-viridian-active-ted-data-signifies-next-round-of-positive-data-on-the-way\">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":"ARGX","symbol_name":"Argenx 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is expected that the 7 major thyroid eye disease markets will reach $4.13 billion by 2034.VRDN-006 and VRDN-008 are two anti-FcRn drugs being developed to treat patients with autoimmune disorders.   FG Trade/E+ via Getty Images The last time I wrote about Viridian Therapeutics, Inc. (VRDN) it was in a Seeking Alpha article entitled “Viridian: Despite Drop, Advancement Towards Phase 3 continues.” At that time, I noted that data from the THRIVE phase 3 study using veligrotug [VRDN-001] for the treatment of patients with active thyroid eye disease [TED], would be released around mid-2024. I'm happy to state that the company just released data showing that this drug was able to meet the primary endpoint of this late-stage study. Having said that, this bodes well for the other data readout expected from this very same program. It is expected that results from the other ongoing THRIVE-2 phase 3 study, using veligrotug for the treatment of patients with chronic thyroid eye disease [TED], will be released by the end of 2024. Besides this update, there is another timeline that is being kept. Viridian states that it is well on track to be in a position to file its Biologics License Application [BLA] of veligrotug for both of these TED indications by the 2nd half of 2025. The scope of this biotech goes beyond that of only targeting veligrotug for the treatment of these eye disorders. It has another product in the pipeline, whereby other companies have already established proof-of-concept. This would be regarding the advancement of VRDN-006 as an anti-neonatal Fc receptor [FcRn]-targeting Fc fragment to treat various types of autoimmune disorders. Going beyond this scope, there is another candidate known as VRDN-008 using the same mechanism of action [MOA] but incorporating a certain type of technology to have an extended half-life [keep drug in the body for a longer period of time]. There is an even a way to create such an extended half-life with veligrotug as well. With positive data from one phase 3 study out of the way, plus another one with an expected readout by the end of 2024, I believe that investors could benefit with any potential gains made. Data From Active Thyroid Eye Disease Study Leads To Highly Positive Data For Next Readout As I noted above, Viridian Therapeutics just released positive data from its phase 3 THRIVE study, which used its drug veligrotug for the treatment of patients with active thyroid eye disease [TED]. Before going over this particular late-stage trial, plus any catalysts to come out of this program, it is first important to note what thyroid eye disease is and what the possible market opportunity could be. Not only that, but to also address the fact that there are two different types of TED. Thyroid eye disease [TED] is a type of disorder characterized as tissue inflammation or damage around the eye. One of the main problems with it would be eye protrusion [eye bulging out], which as I will note below was the primary endpoint being explored for the phase 3 THRIVE study. That is, the efficacy measure referred to as proptosis, or eye bulging out from their normal position. Some symptoms that these patients with this disorder might experience are as follows:  Dry eye  Eyelid swelling  Eye protrusion [bulging as I noted above when eye pops out of socket]  Double vision.  One significant item to highlight about all of these symptoms that are present for these patients would be that they occur specifically because of the eye bulging out the way it does. It is expected that the 7 major thyroid eye disease markets will reach $4.13 billion by 2034. This is a huge market opportunity for sure, but it won't be easy. That's because its drug might be as good or slightly better than an already approved drug known as Tepezza from Amgen (AMGN), which is used to treat patients with TED. Honestly, it's really difficult to assess cross trial comparisons, thus until veligrotug reaches the market, it won't be easy to assess how well it will do. To see if veligrotug would be able to help treat patients with active TED, it ran the phase 3 THRIVE study. This particular study recruited a total of 154 patients who were randomized 1:1 to receive either one of the following doses:  10 mg/kg of veligrotug  Placebo.  Such patients were treated over a 15-week period and then evaluated for the primary endpoint of proptosis responder rate. The key thing to note is that in order for a patient to have been considered to achieve a response from treatment, they had to have a reduction of proptosis of ≥ 2 mm from baseline. The primary endpoint was met in that it was noted that patients who were given drug achieved a 70% proptosis responder rate [PRR] compared to only 5% of the patients that were given placebo. This primary endpoint was met with statistical significance, with a p-value of p<0.0001. The drug was not only able to help regarding such a high response rate, but it also reduced proptosis compared to placebo in a statistically significant manner as well. The patients who were infused with veligrotug achieved a proptosis mean reduction of 2.9 mm from baseline. Whereas on the other hand, those given placebo only achieved a 0.5 mm reduction instead. This is very impressive data for sure, and it will likely possibly be enough to obtain regulatory approval. If this is the case, then how does Viridian hope to go against Amgen's Tepezza? Truthfully, one factor would likely come down to marketing. However, since Amgen's drug has been on the market since 2020, that's not going to be easy. Again, I would rather not make cross-trial comparisons because each study is just designed differently. Plus, the data achieved for veligrotug is quite comparable to Tepezza. Then what possible competitive advantage could Viridian generate? It will be based on what I noted above in the expansion or move to a drug with a similar mechanism of action [MOA], but that has been enhanced. This drug is known as VRDN-003 and it is an anti-IGF-1R monoclonal antibody. Taking it one step further, this specific drug could have two advantages over Tepezza. The first would be the fact that VRDN-003 was developed to be given by patients via a self-administered subcutaneous injection that can be given once every 4 weeks or once every 8 weeks. The second competitive advantage would be the possibility of the drug working better simply because of the extended half-life that is incorporated into it. From what the company believes, this drug is the only anti-IGF-1R in clinical development to have such an extended half-life. Whether this advantage ends up helping the company surpass Tepezza in terms of sales remains to be seen, but it is important to track regardless. To see if VRDN-003 will be able to create both of the competitive advantages I noted above, it has already been able to initiate two phase 3 studies. These two late-stage studies are known as REVEAL-1 and REVEAL-2, and they were initiated in August 2024. However, if these phase 3 studies were just initiated in August 2024, then why should investors keep track of them at all? That's because they are not going to take a lot of time to complete. Matter of fact, it is said that topline data from both the REVEAL-1 and REVEAL-2 studies will be released in the 1st half of 2026. From there, if recruitment goes as expected, then a BLA filing of VRDN-003 for TED could happen by the end of 2026. Going back to the THRIVE program, the next important catalyst would be the release of data from THRIVE-2 which is using veligrotug for the treatment of patients with chronic TED, expected to happen by the end of 2024. Anti-FcRn Market Is Heating Up, But An Opportunity Might Exist With Differentiation Another focus for Viridian Therapeutics would be the use of anti-FcRn drug VRDN-006, which is being developed for the treatment of patients with a wide variety of autoimmune disorders. Specifically, the use of this drug is still considered to be in preclinical development because an IND filing to the FDA to initiate a phase 1 study for it is not expected until the end of 2024. The truth is that the anti-FcRn market in targeting autoimmune disorders is becoming crowded with multiple players. For starters, you have VYVGART HYTRULO, which has been approved to treat Myasthenia Gravis and chronic inflammatory demyelinating polyradiculoneuropathy. Then, you have several other anti-FcRns in clinical development for such patient populations. These would be the likes of IMVT-1402 and batoclimab from Immunovant (IMVT), nipocalimab from Johnson & Johnson (JNJ), and UCB (OTCPK:UCBJY) with rozanolixizumab with approved Rystiggo. The thing is that a lot of these types of drugs are obtaining regulatory approvals for similar indications. With this space being crowded, there has to be a way for Viridian and other players to find some type of competitive advantage. Where the company might be able to generate a competitive advantage would be in terms of treatment delivery. For instance, Rystiggo is given via subcutaneous administration but as an infusion over 15 minutes. VYVGART HYTRULO from argenx SE (ARGX) is given via subcutaneous injection as well. However, 30 minutes after receiving it, a person has to be monitored at a doctor's office. It can also be given at home by a trained Nurse as well. This leads me to a place where Viridian might have an advantage to tout. This would be that veligrotug can be self-administered at home by the patient themselves. Immunovant is another company which can also tout this as well, because it may be able to offer self-administered subcutaneous administration. Another item to note would be that Viridian is also incorporating its extended half-life technology into another anti-FcRn drug in its pipeline, known as VRDN-008. It is believed that such an extended half-life may result in deeper IgG suppression and thus result in superior efficacy over other drugs of the same caliber. However, this still needs to be evaluated and tested in human clinical trials. Financials According to the 10-Q SEC Filing, Viridian Therapeutics had cash, cash equivalents and short-term investments of $571.4 million as of June 30th of 2024. The company does have cash for an extended period of time, especially with the cash runway guidance it had given in its filing. It stated that it believes it has enough cash on hand to fund its operations, or cash runway, into the 2nd half of 2026. This is going to get it past many of the milestones or catalysts that are on the way for the next few years. The thing is that it actually does have an option in place to raise funds if it chooses to use it. This would be regarding a Hercules Loan Agreement that was generated in April 2022. However, such an agreement was amended back in August 2023, whereby the company was able to extend the aggregate principal amount it could borrow to $150 million. The company's cash burn per quarter is $72.3 million. Risks To Business There are several risks that investors should consider before investing in Viridian Therapeutics. The first risk to consider would be in terms of the recent positive data achieved from the phase 3 THRIVE study, which used veligrotug for the treatment of patients with active TED. That's because there is the expected data from the other phase 3 THRIVE-2 study, using the very same drug to treat chronic TED patients, before the end of 2024. Even though the primary endpoint was met in using the drug to treat patients with active TED doesn't automatically mean that the primary endpoint will be achieved for the THRIVE-2 study targeting chronic TED patients. The second risk to consider would then be in terms to the regulatory front for veligrotug for the treatment of patients with TED. Being able to meet the primary endpoint of each respective phase 3 study is only one hurdle that the company needs to pass to garner for regulatory approval. Having said that, there is no assurance that the BLA submission of veligrotug will be accepted by the FDA. Nor, that Viridian will ultimately be successful in being able to obtain marketing approval of the drug in the United States or any other territory. The third risk to consider would be in terms of competition relating to veligrotug for the treatment of patients with TED. That's because, as I highlighted above, there is already an FDA-approved drug to treat these patients by the name of Tepezza. There is no assurance that veligrotug will do well once marketed, nor that it will be able to take market share away from this competing drug for the treatment of this patient population. The fourth and final risk to consider would be in terms of competition for the anti-FcRn drugs being developed in its pipeline, which are VRDN-006 and VRDN-008 for the treatment of patients with autoimmune disorders. First, the goal is to initiate phase 1 studies to get both of these clinical candidates going. There is no assurance that the FDA will allow it to initiate such early-stage studies, nor that they will eventually be successful. Not only that, but there is no guarantee that the competitive advantages of extended half-life or self-subcutaneous administration will be enough to counter the other companies developing the same type of drug in this particular space. Conclusion Viridian Therapeutics has come a long way since I last wrote about it. Matter of fact, it was able to release positive results from its phase 3 THRIVE study, which used veligrotug for the treatment of patients with active thyroid eye disease [TED]. The purpose of going over this particular late-stage trial is because it is also gearing up to report results from its phase 3 THRIVE-2 study, which is also using this very same drug to treat patients with chronic TED. It is expected that this specific data will be released by the end of 2024. If everything goes well with this other expected data readout, then the company should be on track to file its BLA of veligrotug for the treatment of patients with TED in the 2nd half of 2025. While this biotech has an uphill battle to go against competitors in the same space with veligrotug, VRDN-003, VRDN-006 and VRDN-008, it might be able to do well with its products upon reaching the market. This might end up being possible thanks to the two competitive advantages I went over above, which are self-administered subcutaneous injections of the drug and a few of the drugs having extended half-life.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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