Access Pharmaceuticals (OTC:ACCP) has inked a collaborate agreement with BioRASI, a contract research organization (“CRO”), to undertake the first human study of oral insulin product Cobalmin.
BioRASI is a US incorporated services group that assists pharmaceutical companies in the development of novel therapeutics. The company was originally formed in 2002 by a US venture capital firm and the Russian Academy of Sciences, but quickly evolved into a CRO with facilities across the United States and Russia, and more recently, India.
Earlier this month, Access reported that two independent animal studies confirmed earlier findings that Cobalamin offers “significant bioavailability of orally delivered insulin”. At present, there is no product in the market which offers oral administration of insulin. In layman’s terms, bioavailability refers to how well a drug (in this case insulin) is absorbed into the body.
With any application, the key to success is not only to ensure a high percentage of the drug is absorbed, but additionally that it can be predicted ahead of time to ensure correct dosage. Hence Cobalamin as an oral drug delivery technology could supersede many products that still require injections or intravenous therapy (in the case of diabetes the most common practices is a disposable insulin ‘pen’).
Access has previously reported that its Cobalamin-coated insulin containing nanoparticle formulations, delivered orally, provided a pharmacological response (lowering of blood glucose level) equivalent to “greater than 80% of that achieved by insulin delivered subcutaneously” (beneath the skin). Currently Insulin is most commonly given as an injection under the skin, usually into the thigh, buttocks, abdomen or upper arm.
Today’s announcement follows on from the animal trial results, confirming that BioRASI will move to a first-in-man study.
“BioRASI will utilize its Translational Clinical Development Process which has demonstrated the ability to generate high quality human proof-of-principle data very quickly and cost-effectively, particularly in the Russian Federation,” Access stated this morning.
Under the collaborative agreement announced, BioRASI will manage the process to commence the first human trials, including all regulatory approvals. BioRASI will also assist Access in finding partners for its Cobalamin based products in Russia, Eastern Europe and other CIS (Commonwealth of Independent States) countries. Access will also retain the option to extend the agreement to additional Cobalamin-based products.
Perhaps of equal significant, Access also mentioned that BioRASI may take an equity stake in the company “at a future time”.
"This program is a great fit for the capabilities of both bioRASI and our established partners. Given the well understood clinical utility of insulin, establishing the human oral bioavailability of Access' product could be a huge step forward for both the oral insulin product and the broader Cobalamin formulation technology platform,” Boris Reznik, President and CEO of bioRASI commented. “Following initial success in the oral insulin program, we look forward to expanding this collaboration to several other promising Cobalamin-based products."
Disclosure: no position