Closing in on iDEAL primary endpoint data
Headline eight-month Phase II iDEAL study data fromiCo Therapeutics Inc's (ICO.V) lead asset, iCo-007, in diabetic macular edema (DME), is expected by the end of April. Improvements in visual acuity (VA), either alone or in combination with ranibuzumab or laser photocoagulation (LP), could lead to potentially lucrative partnership discussions and trigger a re-rating of the stock.
Final eight-month visit completed in iDEAL study
iCo announced on 5 March that the final eight-month patient visit of iDEAL Phase II study (n=187) in DME has been completed, and that primary endpoint data (change in VA at eight months vs baseline) should be released by the end of April (more comprehensive 12-month data are expected in H214).
Eylea and Iluvien potential competitors
Already approved for wet macular degeneration, Regeneron’s aflibercept/Eylea may also gain US clearance for DME (sBLA filed in late 2013 and target action date of August 2014), as recent VISTA Phase III data showed that bi-monthly doses improved mean VA by 11 letters after two years. Alimera’s Iluvien (intravitreal fluocinolone acetonide implant), approved in Europe and undergoing labelling discussions with the FDA, is another potential competitor with a dosing advantage (one application can provide up to three years of treatment effect). However, risks of raised intraocular pressure and the less marked VA improvements from its current data (compared to aflibercept or ranibizumab/Lucentis) could curtail uptake.
iCo-007 mechanism could provide additive benefit
Given that iCo-007’s mechanism of action (inhibition of c-raf kinase formation) differs from existing treatments (eg anti-VEGF ranibizumab), its potential in the DME market (size estimated US$7bn) could include either monotherapy application (based on how it compared to other treatments) or combination therapy, assuming its addition to another treatment provides incremental improvements in VA.
Valuation: C$34m EV discounts development risk
iCo finished Q313 with C$2.1m in net cash and given the January 2014 C$6.75m equity offering, a November 2013 exercise of C$0.96m in warrants and iCo’s 9M13 burn rate of C$2.6m, we estimate pro forma net cash of C$8.5m as of end December 2013. With a cash runway into Q415 and funding in place to manage the post-iDEAL landscape, iCo’s EV of C$34m discounts iCo-007’s potential in the DME market. Positive data could therefore generate significant upside.
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