Industry News — Clinical Updates
iCo Therapeutics Announces Top-Line Primary Endpoint Data From Phase 2 iDEAL Study in DME
iCo Therapeutics, Inc. (Vancouver, British Columbia, Canada) has announced top-line results related to the 8-month visual acuity (VA) primary endpoint for subjects enrolled in the Phase 2 iDEAL Study to evaluate efficacy and safety following repeated injections of iCo-007 in patients with diabetic macular edema (DME).
iCo-007 is a second-generation antisense inhibitor that targets C-raf (ribonucleic acid -- mRNA) and prevents the signaling of multiple growth factors to prevent production of new and permeable blood vessels in the back of the eye.
The iDEAL trial of 187 randomized patients 18 years and older (185 treated) explores whether varying combinations and concentrations of iCo-007, alone or in combination with other treatments, are effective in improving VA in patients with DME.
Using last observation carry forward (LOCF) and multiple imputation statistical methods, mean changes in VA in all 4 groups of patients at both month 4 and 8 were negative. LOCF showed that mean change in VA at 8 months was approximately - 11 letters (350 µg monotherapy arm), - 21 letters (700 µg monotherapy arm), - 14 letters (350 µg plus laser arm), and - 14 letters (350 µg plus ranibizumab arm).
At 8 months, LOCF also showed that roughly 20% of patients in the 350 µg monotherapy arm gained 5 letters or greater of vision vs 13% in the 700 µg monotherapy arm, 12% in the 350 µg plus laser arm, and 11% in the 350 µg plus ranibizumab arm. At 4 months, patients gaining 5 letters or more in the 350 µg, 700 µg, 350 µg plus laser, and 350 µg plus ranibizumab arms were approximately 24%, 18%, 21%, and 30%, respectively.
In addition, LOCF demonstrated an inverse statistically significant difference in mean VA change from baseline between the 350 µg monotherapy and 700 µg monotherapy arms, meaning there was greater loss of VA in the 700 µg monotherapy arm. There was no statistically significant difference in mean VA between the 350 µg monotherapy and either the 350 µg plus laser or 350 µg plus ranibizumab arms.
When using multiple imputation analysis, there was no statistically significant difference observed between 350 µg monotherapy and each of the 700 µg monotherapy, 350 µg plus laser, and 350 µg plus ranibizumab arms. At 8 months, in the 700 µg monotherapy arm, 64% of patients experienced a 15-letter or greater loss of vision, compared to 33% in the 350 µg monotherapy arm, 33% in the 350 µg plus laser arm, and 41% in the 350 µg plus ranibizumab arm. At 4 months, the corresponding numbers were 29%, 9%, 9%, and 14%, respectively.
Updated June 10, 2014