New efficacy data for investigational Cladribine tablets were presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis ( ECTRIMS ), in London.
The findings, from the phase III CLARITY and CLARITY EXTENSION trials and from the open-label maintenance period of the phase III ORACLE-MS study, demonstrated durable efficacy of Cladribine tablets in patients with multiple sclerosis along with a well-characterized safety profile.
CLARITY and CLARITY EXTENSION studies have confirmed that 20 days of oral dosing over two years was effective in reducing the frequency of relapses and slowing disability progression for up to four years.
In one oral presentation, data from the two-year phase III CLARITY trial and its two-year extension study ( CLARITY EXTENSION ) showed that patients with relapsing multiple sclerosis who received placebo in CLARITY and were switched to Cladribine tablets in CLARITY EXTENSION had significantly reduced annualised relapse rates ( ARR ) ( 0.26 vs. 0.10, P less than 0.0001 ) and were significantly more likely to be relapse free ( 58.0% versus 79.6%, P less than 0.0001 ) at the end of the extension phase.
ARR were maintained for patients who received Cladribine tablets for two years in CLARITY and were then switched to placebo for two years in the extension phase.
The second oral presentation reported data from the open-label maintenance period of the phase III ORACLE-MS study.
ORACLE-MS showed that, for patients with a first demyelinating event, treatment with Cladribine tablets has significantly reduced the risk of progression to clinically definite multiple sclerosis compared with placebo.
For the open-label portion of the study, patients who converted to clinically definite multiple sclerosis during the initial treatment period were switched to Rebif ( Interferon beta-1a ) therapy.
The new data presented at ECTRIMS have shown that patients who had received Cladribine tablets in the initial treatment phase had lower ARR over the maintenance period ( median time on Rebif = 56.0 weeks ) compared with those who had received placebo in the initial treatment phase [ 0.14 for Cladribine tablets 3.5 mg/kg ( n=25 ), 0.24 for Cladribine tablets 5.25 mg/kg ( n=24 ) and 0.42 for placebo ( n=60 ) ].
Cladribine tablets has a unique oral dosing schedule, with two short treatment courses administered orally in years one and two.
Cladribine tablets is an oral small molecule prodrug that selectively and periodically targets lymphocytes thought to be integral to the pathological process of multiple sclerosis. ( Xagena )
Source: Merck, 2016