OXFORD, UK – 28 June 2016 – Glide Technologies today announced results from a successful clinical proof-of-concept study that demonstrated its novel solid formulation of the most widely-used dose of octreotide (100 mcg) achieved bioequivalence to the currently marketed immediate release liquid injectable product (Sandostatin®). Glide’s formulation was delivered using the company’s proprietary needle-free Solid Dose Injector (SDI®), which provides the potential for room temperature stability and patient-friendly administration. Octreotide is approved for use in the treatment of acromegaly and certain neuroendocrine tumours, with the estimated market for immediate release liquid formulations exceeding $150 million.
The clinical study compared the tolerability, pharmacokinetics and bioavailability of 100 mcg of Sandostatin® delivered by needle and syringe with Glide’s octreotide solid dose formulation delivered via SDI®. The results demonstrate that Glide’s formulation achieved bioequivalence, matching Sandostatin® on both maximum peak concentration (Cmax) and area under the curve (AUC). In addition, the study subjects (n=20) confirmed the suitability of the SDI® for self-administration and reported an overwhelming preference for the Glide SDI® over needle and syringe. The Glide delivery system was well tolerated by the subjects who rated injection comfort as 4.45 on a scale of 0-5 (with 5 being most comfortable).
Dr Mark Carnegie-Brown, Glide Technologies’ CEO, commented, “These successful clinical results confirm the progress we are making toward our goal of creating a patient-centric delivery platform by integrating formulation science and device engineering. This positive outcome is an important validation of the recent series of advancements the Glide team has made to the SDI® platform, and provides a strong foundation for the development of our pipeline, including teriparatide.”