Phase 3 TOLEDO study results published

Posted in Industry News on 7th Aug 2018

 

Phase 3 TOLEDO study shows apomorphine infusion provides effective relief of persistent motor fluctuations in Parkinson’s disease (PD) patients whose symptoms are uncontrolled with oral medication

Britannia Pharmaceuticals Ltd has announced publication of the results of the double-blind phase of the TOLEDO study in Lancet Neurology1.

Treatment with APO-go®/MOVAPO® (apomorphine) subcutaneous infusion for 12 weeks gave significantly greater reductions in OFF time (periods when PD medications don’t work) from baseline compared with placebo: –2.47 h/day versus –0.58 h/day, respectively – a treatment difference of almost 2 hours (p=0.0025) and double the change in OFF time recognised as meaningful to PD patients. These reductions were seen in the first week of treatment with APO-go®/MOVAPO® infusion.

Compared with placebo, significantly greater increases in ON time (periods with good motor control) without troublesome dyskinesia – ‘good’ ON time – from baseline were observed with APO-go®/MOVAPO® infusion: 2·77 h/day versus 0·80 h/day, respectively (p=0·0008), and patients could also reduce the dosage and number of administrations of concomitant oral PD medications significantly (p=0.0014).

APO-go®/MOVAPO®/ infusion is an established therapy for PD, a disease characterised by progressive degeneration of dopamine-containing neurons in the brain, resulting in loss of motor control. TOLEDO is the first multicentre, randomised, double-blind trial to investigate its efficacy and safety in PD and was undertaken in 107 patients from 23 hospitals in 7 countries whose symptoms were uncontrolled despite taking multiple medications.

Clinical improvements were reflected in patients’ assessment of treatment: significantly more APO-go®/ MOVAPO® infusion patients rated themselves as ‘improved’ (71%) versus placebo (18%; p<0.0001).

Professor Regina Katzenschlager, lead investigator of TOLEDO, commented:

TOLEDO is an important addition to our knowledge, providing Level 1 evidence for the first time and confirming previous observational studies. Apomorphine infusion is effective and well tolerated by patients experiencing debilitating treatment response fluctuations despite optimised treatment.

Professor Andrew Lees, an investigator in the pivotal clinical trial that led to apomorphine being licensed for PD treatment in the UK, added:

We hope the positive results of the TOLEDO study will help ensure apomorphine infusion, which is delivered using a small, ambulatory mini-pump, is incorporated into national PD treatment guidelines.

The TOLEDO study is sponsored by Britannia Pharmaceuticals Ltd., part of the STADA Arzneimittel AG group of companies and manufacturer of apomorphine products.

  1. Katzenschlager R, et al. Lancet Neurology, 2018. Published online July 25, 2018 http://dx.doi.org/10.1016/S1474-4422(18)30239-4
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