Radius Health has obtained $91 million to fund Phase III trials with an injectable formulation of its osteoporosis candidate BA058. The firm separately announced a deal with 3M Delivery Systems to develop a transdermal delivery formulation of the molecule based on the latter’s Microstructures Transdermal System microneedle technology.
Radius’ third round of funding, with new and existing investors, included $66 million in equity financing and a $25 million loan facility, payable in stages. $22 million in equity and $6.25 million in debt will be received at close, and Radius in addition has issued Ipsen with $1.4 million worth of preferred stock in lieu of a cash milestone payment.
BA058 is a parathyroid hormone-related protein (PTHrP) analog in development as an anabolic therapy for osteoporosis. The Phase III program is designed to support regulatory filings for an injectable formulation of the drug in the U.S. and Europe. The 18-month trial, managed by Nordic Bioscience, will enrol 2,400 patients in eight countries. Data from completed Phase II studies showed that in comparison with Foreo® therapy, BA058 administered as an injection significantly increased bone mineral density at the lumbar spine and femoral neck after six months.
A BA058 Microneedle Patch product based on the 3M platform is already undergoing Phase I testing as an alternative to subcutaneous injection. “Poor adherence to prescribed osteoporosis therapy is a common and serious problem,” notes C. Richard Lyttle, Ph.D., Radius president and CEO. “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.”