Investigational New Drug for Arthritis
A small
pharmaceutical company has completed Phase II studies
with their investigational new drug for the treatment of
arthritis with exceptionally good results. Nine
clinical studies were completed in Phase II. The
studies showed good efficacy with extremely good safety
(very few adverse reactions were recorded). The End of
Phase II Report was favorably reviewed with the FDA
(copies available under confidentiality).
The
drug is a once a day oral administration. GMP
manufacturing is available and can make GMP product.
The drug effect in
the Phase III study was almost identical to the average
of the Phase II studies, however the placebo response
was at the rate of three times that of the Phase II
studies. There was still a positive drug minus placebo
effect but it was not sufficient to reach statistical
significance. Patient monitoring and control may have
been an issue.
The company does
not have the financial resources to repeat the Phase III
study, and is therefore seeking a partner to help
complete development of this drug.
There seems to two
possible options. Since there was a positive, but
statistically non-significant drug effect in the Phase
III study, performing a second study with the intent of
showing statistical significance in the combined results
is one option.
The second option
would be to consider changing the route of
administration. Review of the drugs pharmacodynamic
effects suggest that nasal administration should be more
efficacious that oral administration. Since systemic
oral toxicity has been completed it is thought that
changing administration would only require limited
safety/efficacy tests before being permitted to perform
a new Phase III study with nasal administration.
If you are
interested in partnering to complete development of this
drug, please contact JASRA.
