CHTP (6)
Chelsea Therapeutics is developing
Northera (Droxidopa)
for the treatment of
Neurogenic Orthostatic Hypotension,
with pivotal phase 3 trial results due in mid to late September.
Droxidopa has already been marketed in Japan since 1989 for this indication, by another company.
The Chelsea trials use/used an assessment called Orthostatic Hypotension Symptom Assesment (OHSA), which has the following
Questions:
1. Dizziness, lightheadedness, feeling faint, or feeling like you might blackout
2. Problems with vision (blurring, seeing spots, tunnel vision, etc.)
3. Weakness, 4. Fatigue, 5. Trouble concentrating, 6. Head/neck discomfort
As well as, Orthostatic Hypotension Daily Activities Scale (OHDAS):
1. Standing short time, 2. Standing long time, 3. Walking short time, 4. Walking long time
A prior completed phase III trial (study 302) used Q1 of OHSA (Dizziness) as the primary endpoint but included the remainder as secondary endpoint.
It failed on the primary but showed a benefit in most of the symptoms except for the one they had chosen as primary.
finance.yahoo.com
They had another phase III ongoing study completing at the time (study 301).
The company asked the FDA to allow them to use a composite score of OHSA and OHDAS as it's primary, due to what they noticed from (study 302).
They were permitted to change the Primary endpoint to the Composite score, they added more patients to increase statistical power, and this trial is now set to complete in Mid/Late Sept 2010.
finance.yahoo.com
The Stock fell from $7 to 2.70ish on them missing their primary endpoint in Sept 2009, yet has only recovered to 3 in the meantime.
They may run up some into results; but since you cannot be sure when in Sept that the results are being released, this would be a hold through trial results trade.
The risk reducing aspect is that the 'new' primary endpoint was already met in the prior study so the odds of them meeting it in this study should be good.
Also, the fact that is has been shown to be effective and safe for use in this indication in Japan for a some time now, improves my confidence.
Disclosure: I got me some shares Also trying some options
Other info.
There is a Pivotal (Study 306) that will have data 2nd quarter of 2011, and they expect to initiate NDA in 1st Half of 2011 under Fast Track Designation.
Chelsea has the following other indications in addition to NOH listed as potential indications for Northera, some of which they currently have ongoing or planned trials in:
Intradialytic Hypotension
Fibromyalgia
Adult ADHD
Freezing of Gait
Chronic Fatigue
An approved drug for NOH, Midodrine(ProAmatine) is being considered for removal from the market
reuters.com
Chelsea also has a Non-Metabolized Antifolates program which could address the following indications:
Rheumatoid Arthritis
Psoriasis
Crohn's Disease
Ankylosing Spondylitis
Uveitus
Oncology
I mention this since it is considered to be a potential blockbuster program to fall back on incase the Northera were to lose investment value to shareholders for negative trial results.
It is currently sidetracked while the FDA asks for more information regarding liver issues at the higher doses.
irconnect.com
Update - As of Aug-26, The CH-4051 Antifolate program is back on track.
irconnect.com
Last edited by Steven on Thu Sep 09, 2010 10:09 am, edited 1 time in total.
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