York establishes dosage of Sabarep for Ph IIb trial
UK-based specialty pharmaceutical firm York Pharma says that positive results generated in a human study have established the final dosage composition of its developmental eczema treatment Sabarep (YP001). The firm said that it is now finalizing plans to progress the drug into Phase IIb clinical development, and has initiated manufacture and product testing in preparation for these studies.
The Hitchin, Hertfordshire-headquartered firm also said that the simplified clinical trial program it has developed for Sabarep could be suitable for submission to US regulatory authorities. As a result, the company has asked the Food and Drug Administration for a pre-Investigational New Drug meeting to confirm the acceptability of its plans.
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