Recorlev Developer Strongbridge Secures $53 Million in Financing

Strongbridge Biopharma has entered into an agreement for $50 million in credit and $3 million in equity investment with the healthcare-focused firm CRG to meet the demand for Keveyis (dichlorphenamide) and advance the development of its major therapeutic candidate Recorlev (levoketoconazole).

Recorlev is an investigational cortisol synthesis inhibitor under development for the treatment of Cushing’s syndrome. It is purified from the antifungal drug racemic ketoconazole, which reduces its liver toxicity and other side effects.

Recorlev has received orphan drug status from both the U.S. Food and Drug Administration and the European Medicines Agency. This designation is meant to accelerate the development and approval of a certain therapy by providing incentives to the company, including market exclusivity and fee reductions.

Recorlev is currently being evaluated in the open-label SONICS Phase 3 trial (NCT01838551) as a treatment for patients with elevated cortisol due to Cushing’s syndrome. The study has already enrolled the planned 90 participants.

The trial will first evaluate the effectiveness of ascending doses of Recorlev to find the appropriate dose for higher benefits and fewer side effects among patients who cannot undergo surgery as a treatment. Effectiveness will be assessed as a reduction in the mean 24-hour urinary-free cortisol levels to less than or equal to the normal range’s upper limits.

In a second phase, patients will be maintained at this dose for six months. An additional six-month extension will evaluate Recorlev’s long-term safety.

CRG’s capital infusion will add resources to help accelerate patient access to Recorlev. The funds also will help Strongbridge meet the demand for Keveyis, which has already been approved by the FDA for the treatment of a rare neuromuscular disorder.

“We are pleased to have both the support and confidence of CRG, a premier partner known for its strategic investments to support the growth of healthcare companies,” Matthew Pauls, Strongbridge’s chief executive officer, said in a press release. “The funds received at closing provide sufficient resources for us to build upon the early uptake and demand that we are seeing for Keveyis (dichlorphenamide), and to fund Recorlev (levoketoconazole) through potential regulatory approval and launch.”