The technology uses 3M’s Microstructured Transdermal System microneedle to administer the drug, BA058, through the skin, as an alternative to subcutaneous injection which is associated with poor treatment adherence.
3M Spokesman Diane Kwiatkowski told in-Pharmatechnologist.com that: “We are in the process of rigorously verifying process and formulation conditions and scaling up the drug product to meet the needs of Radius' future clinical studies.”
Kwiatkowski also described 3M’s platform as “an excellent fit with BA058, providing efficient delivery of the API and offering patients an easy, non-intimidating alternative to daily injections with minimal discomfort.
This was echoed by Radius CEO C Richard Lyttle who said: “Poor adherence to prescribed osteoporosis therapy is a common and serious problem.
“Patients who drop their treatment unknowingly place themselves at high risk of fracture, which exacts an enormous toll in terms of human and economic cost.”
Lyttle added that: "By providing a more convenient treatment alternative to injection that can promote improved compliance, the BA058 Microneedle Patch will be well-positioned to drive expansion of the osteoporosis market."
Microneedle Delivery
Kwiatkowski did not say if 3M will continue to be involved if the drug, which is being assessed Phase I clinical trials in the microneedle format and Phase II studies as a subcutaneous injection, progresses through clinical development.
However, she did confirm that the collaboration with Radius is one of a number of microneedle-focused projects 3M is involved in at the moment but, again, could not go into detail for reasons of client confidentiality.
Phase III funds
In related news, Radius recently completed a financing round, raising $91m (€64m) the majority of which it said it would spend on conducting Phase III clinical trials of BA058.
Danish contract research organisation (CRO) Nordic Bioscience will run the study, which is expected to last 18 months and enrol 2,400 people at 11 research centres in eight countries.