Adverum: Ixo-Vec Could Reduce Treatment Burden For Wet-AMD Patients

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Adverum Biotechnologies, Inc. achieved positive results from both the LUNA and OPTIC studies, using Ixo-vec for the treatment of patients with wet age-related macular degeneration.The phase 3 ARTEMIS ...

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About 10% of all AMD patients have wet age-related macular degeneration.The company had $153 million in cash as of September 30th of 2024; enough cash to fund its operations into the 2nd half of 2025.   Alessandro Biascioli  Adverum Biotechnologies, Inc. (NASDAQ:ADVM) just reported positive results from two of its studies using its gene therapy Ixo-vec for the treatment of patients with wet age-related macular degeneration [Wet-AMD]. Both of these studies prove that one intravitreal injection of this therapy given over an extended period of time was able to maintain visual and anatomic efficacy endpoints. Patients saw a considerable reduction in treatment burden. The premise here is that one intravitreal [IVT] injection of Ixo-vec reduced such burden for an extended period of time in both studies, with a considerably good safety profile. One phase 2 trial that was explored was the phase 2 randomized 52-week LUNA study, and then the other was the 5-year open-label OPTIC study. The premise for both of these studies was to explore the use of Ixo-vec for the treatment of these patients with Wet-AMD over an extended period of time. Both doses of this therapy performed well. However, the company was able to choose the higher 6E10 dose of Ixo-vec to move forward with in two pivotal registration studies. The first phase 3 study of which is to be known as ARTEMIS, which is going to use this gene therapy to treat these Wet-AMD patients over a 52-week/56-week period. That is, for 6E10 Ixo-vec to prove non-inferiority compared to that of 2 mg of EYLEA [aflibercept] given once every 8 weeks in terms of best-corrected visual acuity [BCVA], which will be the primary endpoint. Most importantly, beyond this therapy being able to preserve vision for these patients, it would be even better if it yet again proves to reduce injection burden for them. The phase 3 ARTEMIS trial is expected to begin in the 1st half of 2025, which is a catalyst opportunity that investors should keep an eye on. Ixo-vec For The Treatment Of Patients With Wet Age-Related Macular Degeneration As I noted above, the company was able to report positive results from two of its studies for its lead program, using Ixo-vec for the treatment of patients with wet age-related macular degeneration [Wet-AMD]. These two studies are the randomized, placebo controlled 52-week phase 2 LUNA study and the open-label 5-year extension OPIC study. Before going over the data from either of these studies, plus any catalysts to come out of this program, it is first important to understand what this disorder is and what the possible market opportunity for it could be. Macular degeneration is a disorder characterized as the loss of centralized vision. It is caused by old age where the macula over time becomes damaged and leads to some loss of vision. The macula is part of the retina [tissue in the back of the eye] and is responsible for being able to create vision for the person to see things in front of them. This disorder is broken up into two types of macular degeneration, and they are as follows:  Wet age-related macular degeneration [Wet-AMD]  Dry age-related macular degeneration [AMD].  For the purpose of Adverum, the goal is to go after Wet-AMD patients. However, one key thing I have noted with both studies that were completed, it has the chance to go after a large market segment of this subpopulation. It is looking at recruiting both treatment naive and treatment experienced Wet-AMD patients. The global age-related macular degeneration market is expected to reach $19.53 billion by 2032. Even though the focus is only to go after Wet-AMD patients, it would still be a pretty good opportunity regardless. It is said that roughly 10% of AMD patients are classified as having Wet-AMD. To see if Ixo-vec would be able to help treat these patients with Wet-AMD, the company ran the two studies I have noted above. The first of which is the 52-week phase 2 LUNA study, which explored the use of this gene therapy with multiple prophylactic regimens. Why were such regimens to be explored with Ixo-vec? It is because, as I will explain below, there is a balance of the therapy provided the ability for patients to maintain vision and reduce injection burden, along with prophylactic regimens being put in place. These reduce any type of inflammation that could possibly become present with such treatment over an extended period of time. Patients for this trial were given either one of the following doses below:  High dose 6E10 vg/eye  Low dose 2E11 vg/eye.  They were given these doses of gene therapy in combination with 1 or 4 corticosteroid treatments. The data released from this LUNA study showed treatment reduction burden and a percentage of patients who were injection free. This was shown in the study as follows:  6E10 vg/eye achieved treatment reduction burden of 88% & 54% of patients being injection free  2E11 vg/eye achieved treatment reduction burden of 92% & 69% of patients being injection free.  This accomplishes the two goals I highlighted at the beginning of this article, but this is not what will be needed to receive U.S. FDA approval of Ixo-vec for the treatment of these patients with Wet-AMD. Instead, what will be needed will be the ability to meet non-inferiority compared to that of EYLEA in terms of best corrected visual acuity [BCVA]. The non-inferiority measure of -4.5 letters is what is needed to meet this goal. Well, there is good news on this front, because of what has been shown with the release of the latest results. That is, BCVA change from baseline for patients given each dose of Ixo-vec was as follows:  6E10 dose of Ixo-vec : -2.1 letters  2E11 dose of Ixo-vec : -1.8 letters.  As you can see, in both cases, the gene therapy was able to achieve this primary efficacy outcome measure. Thus, the hope is that this can once again be replicated in phase 3 clinical testing. Speaking of phase 3 testing, the plan is for Adverum to initiate two double-masked, randomized late-stage studies for this program. The first pivotal trial of which will be known as ARTEMIS and will enroll a total of 284 patients. The primary efficacy measure will be that of non-inferiority of BCVA between 6E10 vg/eye compared to that of 2 mg Q8W [once every 8 weeks] EYLEA [aflibercept]. Again, the margin of BCVA to be noted for such non-inferiority to be proven would be -4.5. One thing to note is that prophylactic treatment regimens will be deployed again with Ixo-vec. Not only that, but the company is likely to help give a boost in providing three monthly loading doses of EYLEA before being given Ixo-vec. This is where a catalyst opportunity comes into play in relation with the advancement of this program. It is expected that the phase 3 ARTEMIS study is expected to be initiated in the 1st half of 2025. Financials According to the 10-Q SEC Filing, Adverum Biotechnologies had cash, cash equivalents and short-term investments of $153 million as of September 30th of 2024. The reason for the cash on hand is that it enacted a private placement agreement with both new and existing investors back in February 2024. This fundraising activity helped to bring in approximately $127.5 million in net proceeds before deducting expenses. The company is likely going to need to raise cash in the coming months. Thus, I would anticipate a cash raising activity to happen soon. The belief is that it will have enough cash on hand to fund its operations, or a cash runway, into late 2025, but this doesn't include enough to complete the phase 3 ARTEMIS trial. Nor, does it entail the other pivotal registration study that will be needed to eventually obtain FDA approval of Ixo-vec for the treatment of Wet-AMD patients, either. The company's cash burn is roughly $30.2 million of cash per quarter. This is broken down into $20.4 million in R&D expenses and then $9.8 million in G&A expenses. Risks To Business There are several risks that investors should be aware of before investing in Adverum Biotechnologies. The first risk to consider would be in terms of the initiation of the phase 3 ARTEMIS study, which is expected to take place in the former half of 2025. The risk here is that there is no assurance that this late-stage study is going to meet the primary endpoint of non-inferiority with statistical significance over a 52-week/56-week period. Nor, that the other phase 3 study to be started under this very program will achieve a similar efficacy outcome. The second risk to consider would be in terms of the regulatory front. Even if the company can meet the primary endpoint of non-inferiority of Ixo-vec compared to that of EYLEA regarding BCVA, there is no assurance that the FDA will allow it to submit a Biologics License Application [BLA] of this gene therapy of approval for these patients with Wet-AMD. Even if this agency does accept such a regulatory application for Ixo-vec, there is no guarantee that the FDA will grant U.S. marketing approval for it to treat these patients. The third risk to consider would be in terms of the financial position that it is in. Despite having raised approximately $127.5 million in a private placement back in February 2024, this is still not enough cash to carry it forward. Again, the projection is that it only has enough to fund its operations into late 2025. Having said all of this, the risk here would be that the company is going to enact some type of cash raising activities in the coming months. The fourth and final risk to consider would be in terms of the competitors that the company might have to deal with in the Wet-AMD space. The two drugs in particular that Adverum may have to contend with are EYLEA HD from Regeneron Pharmaceuticals (REGN) and VABYSMO from Roche (OTCQX:RHHBY). The reason is that these drugs were designed in mind to offer fewer injections. That is, to go from 6 to 12 injections per year down to about 3 to 4 instead. The goal for Adverum is to use Ixo-vec to accomplish one single intravitreal injection that can have a long-lasting effect. Thus far, this has been proven over a 4 to 5-year period, as shown above. The risk here is that there is no assurance that even if the company can receive FDA approval of Ixo-vec that it will be able to generate superior sales to that of these or any other anti-VEGF competitors. One other item to note is that REGENXBIO (RGNX) is also working on a gene therapy for the treatment of patients with Wet-AMD, known as ABBV-RGX-314. This AAV8 gene therapy is being developed in collaboration with AbbVie (ABBV). Conclusion Adverum Biotechnologies has done well to develop the use of its AAV2.7m8 gene therapy Ixo-vec for the treatment of patients with Wet-AMD. It has been able to report positive results from its 52-week LUNA study, targeting these patients with prophylactic regimens. The thing is that this AAV2.7m8 vector is strong because it can achieve substantial transduction of the gene therapy to the retina via intravitreal [IVT] injection. However, its efficacy is profound, so much so that there is some inflammation that occurs as a result. In the OPTIC study, it was noted that there was inflammation present and that there was insufficient prophylaxis capable of stopping it. Well, definitely the lesson was learned because in LUNA it was noted that treatment with Ixo-vec in combination with prophylaxis regimens not only helped such patients to maintain vision, but to also have a considerably good safety profile. Thus, this is the reason the phase 3 ARTEMIS study is moving to use this gene therapy in combination with a specific prophylactic regimen. No patients in the LUNA study, after 52-weeks of treatment with Ixo-vec and local steroid prophylaxis, had any type of inflammation present. Despite the extended period of time in the OPTIC study of 4-years, there was still an 86% reduction of anti-VEGF treatment burden during this extended period. With positive results presented for Ixo-vec in treating Wet-AMD patients in both the LUNA & OPTIC studies, plus the phase 3 ARTEMIS expected to be initiated in the 1st half of 2025, I believe that investors could benefit with any potential gains made here.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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