| Three Oral Peptides in Clinical Development and Two Oral Peptides in Pre-Clinical|
Proxima’s lead projects focus on new delivery systems for enhancing the uptake of peptides, proteins and other macromolecules when administered via the oral route in a capsule. Proxima has developed its own proprietary technology which can increase the absorption of peptides across the intestine by at least an order of magnitude. Patent applications have been filed,with first teritories granted,and proof of concept of the system has been demonstrated in large animals and humans, showing detectable levels of peptide in the blood stream, and a significant biological response. In contrast to all other known systems for oral peptide delivery currently being commercialised, Proxima’s delivery vehicle is simple and cheap to manufacture, and consists entirely of registered pharmacopoeial excipients, for which no regulatory obstacles are anticipated. Product scale-up, trial and launch can therefore be conducted very rapidly, particularly in emerging markets, and as a consequence human phase IIa clinical trials have been completed for insulin and salmon calcitonin aswell as a phase I trial for parathyroid hormone. In addition, phase I is in the planning stage for two further molecules of high potential market value. — Positive phase IIa result with oral insulin (Capsulin™) and oral sCT (Capsitonin™) — This delivery vehicle is potentially capable of incorporating a range of peptides for proof of concept feasibility studies to show oral absorption. Delivery into the bloodstream is typically between 5 and 10% of the administered dose. The formulation is stable for at least 11 months at +4°C. Axcess creates no new issues to manufacture and scale-up, and contains no new chemical entities. Toxicity of the formulation is low. Previous history of clinical use of excipients – easier registration pathway anticipated. Patent applications cover novel indications and novel compositions.