Recently, Johnson & Johnson (JNJ) announced results for the first two late-stage studies for its depression drug esketamine. One trial had succeeded, while another one had failed. However, I believe esketamine still has a good chance of reaching the market. Being that it is a different type of treatment, it may offer patients with a new way to treat their depression. For that reason, I believe that Johnson & Johnson is a buy.
There were two late-stage studies that were done. Each of these studies was evaluating treatment-resistant depression using J&J’s nasal spray esketamine. One thing to keep in mind was that both studies were done in patients who had gone through 2 or more currently available antidepressants.
The first study was done in adults with treatment-resistant depression (major depressive disorder). There were two study arms that were incorporated into this first late-stage study. Patients were treated with esketamine nasal spray (84 mg or 56 mg) added to a newly initiated oral antidepressant against a placebo nasal spray added to a newly initiated oral antidepressant. The primary endpoint was evaluated using the Montgomery-Asberg Depression Rating Scale (MADRS). It was shown that those given the treatment arm of esketamine achieved statistical significance over the placebo arm with a p-value of p = 0.010. Unfortunately, none of the secondary endpoints were met. The way I feel about these results is that it is good to see that the primary endpoint was met with respect to this study. That’s because these are patients with major depressive disorder (MDD) who go through two or more treatments without responding. The fact that they actually responded well with esketamine, a nasal spray for depression, is highly encouraging. Plus, the only thing that matters to the FDA is if the primary endpoint hits. The secondary endpoints being met would have been a bonus, but they are not necessary for regulatory approval.
The second late-stage study was done in elderly patients with treatment-resistant depression. This study design was almost the same as the first study above. Patients were given 28 mg, 56 mg, 84 mg plus a newly initiated oral antidepressant or placebo nasal spray plus a newly initiated oral antidepressant. Do you spot the difference here compared to the other study above? The difference being that this population was elderly and more vulnerable to depression. Therefore, J&J had to start off patients with a smaller 28 mg dose of esketamine. Unfortunately, this study did not meet the primary endpoint like the other one above in adult patients. The p-value was p = 0.029, which means the treatment arm was not statistically significant over the placebo arm. However, there is a positive that came out of this second study in elderly patients. I am inclined to say that it was very close to reaching statistical significance. Despite not reaching statistical significance, treatment was still highly in favor for the esketamine arm over placebo.
Analysis Of Both Studies
The end result was the one late-stage study in adult patients with treatment-resistant depression met the primary endpoint, while the other one did not (it was very close). However, there are positive takeaways from each of the studies. In the study with adults, it was the first time that an antidepressant was able to achieve superiority in a clinical study for MDD that added a newly initiated oral antidepressant. For the second study, it was one of the first large studies in treatment-resistant depression for this elderly population. Despite the second study in elderly patients not meeting the primary endpoint, it must be noted that it was noble for J&J to try and tackle such a difficult population to treat. Especially when you consider that depression trials are complicated. That’s because a high placebo response is always noted in a majority of depression trials. The best takeaway though is that there is a huge opportunity for J&J here. Simply because there are about 30% of patients with MDD who are treated with 2 or more therapies and don’t respond. In my opinion, that’s still a huge population to go after in MDD. Can J&J file for regulatory approval? Well, they can but here is the catch. These results were only from 2 of the total 5 treatment-resistant depression studies. That means J&J has 3 more studies to be readout in 2018, that can potentially sway more positive data in its favor.
Despite the initial mixed results from the first two studies, J&J will move on to file for U.S. regulatory approval soon. I think it’s a good move because it still has another 3 studies to be readout soon in 2018. I’m willing to bet that at least one out of the three remaining will be successful. Even looking at that as a worst-case scenario, it would still be bullish for FDA approval. From what I have seen, the FDA typically wants two positive late-stage studies in order to approve a drug for depression. A risk would be that if esketamine is approved by the FDA, it still won’t be an easy market to go after. That’s because some of the adverse events noted during the study mean that this drug will have to be given under clinical supervision. That may hinder the market opportunity a bit. Still, it is good to see that patients will have a new treatment option. Especially, in both of these populations that are difficult to treat. For that reason, J&J is a buy.
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical investment research service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to my Service, I’m currently offering a two-week free trial period for subscribers to take advantage of. My service offers deep-dive analysis of many pharmaceutical companies throughout the biotech sector. Come see for yourself if my service is right for you.
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