Novartis Pasireotide drug meets Phase III study endpoints

7th March 2012 (Last Updated March 7th, 2012 18:30)

Switzerland-based Novartis' investigational drug Signifor (SOM230, Pasireotide) has demonstrated normalised cortisol levels in a Phase III study conducted in patients with Cushing's disease.

Novartis

Switzerland-based Novartis' investigational drug Signifor (SOM230, Pasireotide) has demonstrated normalised cortisol levels in a Phase III study conducted in patients with Cushing's disease.

Pasireotide is an investigational multireceptor-targeting somatostatin analog (SSA) that binds with high affinity to four of the five somatostatin receptor subtypes, and is being studied as a long-acting release (LAR), once-monthly intramuscular (IM) injection as part of a global Phase III programme.

PASPORT-CUSHINGS (PASireotide clinical trial PORTfloio-Cushing's disease) is a prospective randomised double-blind Phase III study involving 162 adult patients with persistent or recurrent Cushing's disease and urinary-free cortisol (UFC) levels greater than 1.5 times the upper limit of normal (ULN), as well as in patients with newly diagnosed Cushing's disease who are not candidates for surgery.

In the trial, patients were randomised to receive Pasireotide subcutaneous (sc) injection in doses of 900µg or 600µg twice daily to assess the efficacy and safety of the drug candidate.

The primary endpoint of the study was the proportion of patients who achieved normalisation of UFC after six months without dose up-titration relative to randomised dose. Secondary endpoints included safety and the proportion of patients with UFC at months three, six and 12.

UFC levels were normalised in 26.3% and 14.6% of patients with Cushing's disease randomised to receive Pasireotide 900µg and 600µg twice daily, respectively, at six months of treatment.

After 12 months, 25% and 13.4% of patients showed normalised UFC levels when treated with 900µg and 600µg of Pasireotide respectively.

The trial data also demonstrated that cortisol levels decreased in the majority of patients, with a median decrease of approximately 50% by month two, and remained stable in both groups throughout the study period.

Novartis Oncology president Hervé Hoppenot said: "These positive study results demonstrate that pasireotide has the potential to be an important therapeutic option for patients living with Cushing's disease and reinforces Novartis' commitment to develop therapies to help address unmet medical needs.

"We look forward to working with regulatory authorities worldwide to help bring this novel treatment option to market."

Image: Novartis headquarters in Basel. Photo: Andrew.