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
into the bloodstream is typically between 5 and 10% of the administered
- The formulation is stable for at least 11 months
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.