iDEAL study misses primary endpoint
Top-line data from the iDEAL Phase II study with iCo-007 in diabetic macular edema (DME) did not show a benefit in visual acuity (VA) after eight months, either alone or in combination with Lucentis or laser photocoagulation (LP). Full 12-month data are due in Q414, but the ~80% share price decline on the results, leading to a negative EV, suggests low investor expectations for a turnaround or further development of iCo-007.
VA declined across all study arms
All four dosage arms (350mcg monotherapy, 700mcg monotherapy, 350mcg+LP, 350mcg+Lucentis) of the iDEAL trial (n=187) showed mean reductions in VA vs baseline, with the lowest decrease (11 letters) occurring in the 350mcg arm and the highest decrease (21 letters) in the 700mcg arm. There was a significant difference in mean VA change between the 350mcg and 700mcg arms in one of two applied statistical methods, but no significant VA changes were found across other group pairings. The top-line data do not suggest a clinical benefit from iCo-007 therapy.
Eylea and Lucentis trials show VA benefits
The VA reductions in iDEAL contrast the pivotal DME study data for Lucentis (approved in DME) and Eylea (filed), with typical line improvements after 24 months of 11-12 letters (vs baseline), with 8-9 letter gains versus the placebo groups. The VA declines in iDEAL are curious given a recent ARVO abstract indicated that patient demographics are consistent with other phase II/III DME studies, although further analyses are ongoing. There was no true control arm (iCo-007 naïve) in iDEAL.
Subgroup analyses could provide glimmer of hope
iCo Therapeutics Inc (TO:ICO) intends to release full 12-month data in Q414, including OCT measures of macular thickness. As ~20% of patients in the 350mcg arm gained 5 letters of VA, compared to 11-13% in the other arms, subgroup analyses could potentially uncover a population that may benefit from treatment. However, such a subgroup would likely be a fraction of the overall DME population, and a confirmatory Phase II trial would likely be required before partnership/out-licensing.
Valuation: iDEAL miss leads to negative EV
The iDEAL setback dashed investor hopes for a timely partnership transaction, prompting the shares to fall ~80% since 6 June, leading to a negative (C$2.2m) EV. The firm’s C$7.2m cash position (31 March 2014) should fund operations into Q415, so any positive findings from the iCo-007 full analysis could spark a recovery.
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