Novartis Phase II ACZ885 trials meet primary endpoints

12th November 2012 (Last Updated November 12th, 2012 18:30)

Novartis has announced that two Phase II trials of ACZ885 conducted in patients with familial mediterranean fever (FMF) and tumour necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS) met their primary endpoints.

Novartis has announced that two Phase II trials of ACZ885 conducted in patients with familial mediterranean fever (FMF) and tumour necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS) met their primary endpoints.

ACZ885 demonstrated the reductions in disease attack frequency, symptom relief, normalisation of blood markers of inflammation and quality of life improvements in the studies.

Istanbul Faculty of Medicine rheumatology professor and lead FMF study investigator Dr Ahmet Gül said patients suffering with periodic fever syndromes can be incapacitated with pain and fever during attacks.

"Although rare, these syndromes have a serious impact on the patients and families by limiting their ability to participate in daily life during an attack, so it is critically important to research new treatment options that can neutralize the underlying inflammation, and help patients to live a normal life," Gül said.

"All the patients in the Phase II FMF study demonstrated a minimum of 50% reduction in the frequency of disease attacks during three months of ACZ885 treatment."

All the patients in the Phase II FMF study demonstrated a minimum of 50% reduction in the frequency of disease attacks during three months of ACZ885 treatment.

During the three-month ACZ885 treatment period, eight of the nine patients were attack-free, while blood markers of inflammation normalised by day eight after ACZ885 dosing, and remained low throughout the study.

ACZ885 also provided sustained symptom relief in patients with TNF-receptor associated periodic syndrome in the Phase II study .

Patients experienced improvements in both physical and mental measures of quality of life when assessed during the initial four-month ACZ885 treatment period.

The studies reported similar adverse events to those already reported for ACZ885's approved indication, Cryopyrin-Associated Periodic Syndromes.

Novartis pharmaceuticals division integrated hospital care global development head John Hohneker said; "We are dedicated to realising the potential of ACZ885, wherever alternative treatment options fail to appropriately help patients and whenever a strong scientific rationale comes into play."