Ambrilia Biopharma Inc announced that its board of directors has approved the termination of the phase-III clinical Study 303 as part of ongoing measures to effectively reduce costs. Study 303 involves clinical centres in both Europe and the USA and was designed to evaluate the 30mg, 20mg and 10mg dosage forms of Ambrilia's octreotide acetate (C2L) in acromegalic patients. All patients enrolled in Study 303 reached the 6-month visit and there were no adverse effect or safety concerns.
Ambrilia, through various partners, is continuing with its regulatory filings process and discussions, utilizing the results from earlier studies completed namely, 301 and 302. Top line results of Study 302, an open label extension of Study 301 in which all patients were administered C2L, were previously announced. Analysis following the 24-week extension treatment period provided longer term safety data (up to one year on C2L) as well as supportive efficacy data. A decision was recently taken not to collect further data in this group of patients.
Ambrilia Biopharma Inc is a biotechnology company focused on the discovery and development of novel treatments for viral diseases and cancer.