AutoImmune Disease Treatments
Based on discussions with the FDA, the results of the prior clinical trials, and discussions with the Company’s EU CRO partner that the next clinical trial will be a well-powered EU Pivotal Clinical Trial, due to the following factors:
Type 1 bovine collagen has been shown safe and efficacious in Phase I & IIa clinical trials.
There are no FDA-approved or EMEA-approved therapies for SSc, and the few treatment options available primarily focus on symptoms and palliative therapy. Current immunosuppressants are used with only mixed success.
SSc is a fatal disease with some patients living only three years post-diagnosis, and the median survival time of SSc patients is estimated at 11 years.
There are approximately 100,000 patients with SSc in the US, with 150,000 in Europe, though this number may be understated due to misdiagnosis. This has led to the grant of Orphan Drug Status for ARG201 in the US and the EU, with lower regulatory hurdles, detailed guidance from regulatory authorities in developing clinical trials and quicker development times due to smaller patient populations.
As an Orphan Drug, ARG201 can receive seven years market exclusivity in the US and ten years exclusivity in Europe, if approved for sale.
The FDA has designated ARG201 as a biologic. In the US a biologic has a 12 year market exclusivity period.
In the EU the company has positioned ARG201 to commence a pivotal clinical trail. arGentis in cooperation with a EU CRO has completed the following milestones toward commencing a pan European clinical trial: ·
Obtained Orphan Drug designation by the EMEA for ARG201. ·
Identified 8 major medical centers to participate in the clinical trial.
Identified 20 experienced investigators within these medical centers to conduct the clinical trial.
Identified a EU company to purify the CI for ARG201.
Determined that successful completion of this trial will position ARG201 for approval in the EU.
Determined the size of the trial population.
Determined the patient selection criteria.
Outlined the clinical trial protocol subject to discussion with the EU regulatory agencies.