- Aimmune shows up big in preventing peanut allergic reactions.
- Bristol-Myers lands their more favorable dosing schedule for nivolumab.
- Dermira bombs on phase 3 acne data.
Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.
Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.
Aimmune shows up big in preventing peanut allergic reactions
Company: Aimmune (AIMT)
Disease: Peanut allergy
News: AIMT presented full results of their phase 3 PALISADE trial, which examined the ability of AR101 to prevent allergic reactions in patients with peanut allergy who were exposed to varying doses of peanut protein. These findings were formally presented at the 2018 American Academy of Allergy, Asthma, and Immunology-World Allergy Organization Joint Congress. At the exit challenge, AR101 led to a massive increase over placebo in patients who were able to tolerate each dose of peanut protein.
Looking forward: I covered the top-line data announcement for this back in February, but it's still important to see that the full data were reported and can be scrutinized, and with some more detail. For example, AIMT also divulged the usage of adrenaline in the exit challenge. Only 9% of patients in the AR101 arm needed adrenaline, compared with 44% in the placebo arm. AR101 was also associated with a relatively small rate of treatment discontinuation due to gastrointestinal adverse events (6.7%). But overall, these findings highlight some serious promise for AR101 in patients with peanut allergies, and I won't be surprised if Aimmune pursues approval later this year on the basis of these data.
Overall, a great reminder of very good news for Aimmune that portend big, important things for the company in 2018.
Bristol-Myers lands their more favorable dosing schedule for nivolumab
Company: Bristol Myers-Squibb (BMY)
Disease: Various forms of cancer
News: BMY announced that the FDA has granted approval to their supplemental application for nivolumab, expanding its use to include dosing at twice the strength (480 mg vs 240 mg) half as frequently. So now patients have access to a once-every-four-week schedule, making it the most convenient of the immune checkpoint inhibitors at this time.
Looking forward: If you follow my new monthly column "PDUFA Watch List," then this news won't come as a shock to you, as the date for the application's action date was well publicized. As it stands, this potentially gives BMY a significant edge over competitors, since doctors will have to make treatment decisions for their patients who may live far away from an infusion center. Considering nivolumab is equal to other immune checkpoint inhibitors in terms of efficacy (where it's approved), this could actually make a very big difference for the drug.
I think this is underrated great news for BMY, which may give them a serious edge over competitors in a crowded, rather undifferentiated space.
Dermira bombs on phase 3 acne data
Company: Dermira Inc (DERM)
Therapy: Olumacostat glasaretil
Disease: Moderate-to-severe acne vulgaris
News: DERM announced top-line findings from their two pivotal phase 3 trials assessing the anti-acne activity of olumacostat glasaretil. Unfortunately, although there was a numeric reduction in the number of non-inflammatory and inflammatory lesions compared with placebo, this fell well short of significance. Luis Peña, the chief development officer for DERM, indicated that the program will likely be discontinued.
Looking forward: Definitely bad news for DERM. Although this wasn't the only program (or even the most important one, arguably), having a failure in phase 3 is a very expensive way to find out the drug does not work as intended. And now DERM will need to rely more heavily on the hopeful approval of their topical drug for hyperhidrosis.
Overall, it's bad news, but it's definitely not the end of the line for DERM.
Author's note: Thank you for taking some time out of your day to read some commentary on recent biotech happenings. I hope you'll consider leaving a comment or a question in the section below! This is one way in which Seeking Alpha is able to gauge the effectiveness of its writers and the platform. So if you want to keep seeing more editions of "3 Things," go ahead and participate!
As I mentioned above, I am now collaborating with Avisol Capital Partners on their Marketplace service known as the Total Pharma Tracker (TPT). Some of my work will be available to TPT subscribers either exclusively, or in advance. I will also collaborate in developing watchlists and other investment essentials. Please subscribe to TPT by clicking on this link - Total Pharma Tracker.
This article was written by
Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.