Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

Taking A Look At Adamas Pharmaceuticals Inc (ADMS)’s Upcoming Parkinson’s NDA

Adamas Pharmaceuticals Inc (NASDAQ:ADMS) just announced its intention to submit an NDA for its lead Parkinson’s candidate before the year draws to a close. Alongside the announcement came some updated data, so here’s a look at what the data offers in terms of chance-of-approval insight, and what an approval might mean for Adamas and its shareholders going forward.

As ever, let’s take a look at the science behind the drug before we get into the data. We mentioned it’s a Parkinson’s target, but that’s not strictly accurate. The drug aims to treat a condition called dyskinesia – specifically, a type of dyskinesia called Levodopa induced dyskinesia. Levodopa is a generic drug (although it’s sold in various branded forms) that is administered as a standard of care treatment for Parkinson’s disease sufferers. It’s an amino acid supplement, and it stimulates dopamine production post administration.

Parkinson’s is caused by a particular type of neuron in the brain dying – the neuron that is responsible for dopamine production. This lack of dopamine translates to the common movement related issues associated with the condition. Levodopa temporarily helps to replenish dopamine, but over a long course of treatment, can itself cause motor related issues. Specifically, the type of dyskinesia that Adamas is targeting with its development candidate, ADS-5102. The drug is an extended release, oral administration capsule, designed to impact plasma levels of what is called amantadine, a dopamine agonist.

pharmacist, store, shelves, drugs, chemist, profession, horizontal, adult, drugstore, one, female, medicine, health care, woman, showing, prescribing, indoors, doctor, prescribe, sell, white, medical, retail, occupation, caucasian, smile, holding, standing, person, lab coat, shop, pharmacy,

bikeriderlondon/Shutterstock.com

So what did the data from the trial show? Well, the clinical side of the study, and the element that supports the NDA, is rooted in three separate phase III trials – EASED, ID and EASELID 3. There is also an ongoing trial called EASELID 2, which is open as a continuation (primarily as a way to gather long term safety data) for any of the patients that took part in the initial trials to continue with their dosing regimen. All three trials measured the change in LID activity compared to a placebo arm using a special measurement system called the Unified Dyskinesia Rating Scale (UDysRS).

The EASED trial took the measurement at eight weeks, the EASELID at twelve and twenty-four weeks, and the EASELID 3 at twelve weeks. The data just released relates specifically to the EASELID trial, and reported a positive treatment response across all demographics. The trial hit its primary endpoint, registering a highly significant improvement from baseline in the above mentioned UDysRS in all patients that completed the trial. The drug also met 5 predefined secondary endpoints, and the incidence rate (as measured by comparing the rate of AEs to the already established safety profile of amantadine) was no cause for concern.

So that’s the data and the science, what are we looking for going forward from Adamas Pharmaceuticals Inc (NASDAQ:ADMS) as a potential upside catalyst? As mentioned, the company is looking to file an NDA based on the published results before the end of 2016, and this filing (as well as the FDA’s subsequent acceptance of the submission) will serve as the major upside driver heading into H2 2016. There are a few other things worth keeping an eye on, however. The ongoing safety trial (the EASELID 2 trial mentioned above) is set up so that Adamas can collect data on the long term safety profile of this oral administration version of an already approved formulation. As such, the company will want to ensure it maintains an AE rate that is consistent with its earlier phase trialing, and concurrently, that of its control arm.

This should be an issue, as there has been no indication to date that the drug causes any concerns outside of those normally regarded as acceptable. It’s worth keeping an eye on, however, as if something comes up then Adamas will have to report it to the FDA and it could impair the drug’s potential from a green light perspective. Cash is also worth watching. Adamas Pharmaceuticals Inc (NASDAQ:ADMS) has a few lead pipeline projects underway, and only around $98 million cash on hand (as of March 31, 2016). This should see it through to NDA submission with no issues, but commercialization can quickly burn cash, so it’s likely to require some level of financing before the close of next year.

Follow Adamas Pharmaceuticals Inc (NASDAQ:ADMS)
Trade (NASDAQ:ADMS) Now!

Note: This article is written by Roger Hannington and originally published at Market Exclusive.

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...
X

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!