Daylight unlikely to break for Kodiak

In Kodiak’s defence, the group probably had little alternative to carrying out a head-to-head trial of KSI-301 versus Eylea in wet AMD if it was to have any chance of elbowing onto this packed market. However, the attempt has ended in an emphatic failure and an 80% share price crash. Not only did ’301, a supposedly long-acting option, prove inferior to Regeneron’s blockbuster on best corrected visual acuity, intraocular inflammation occurred in 3.2% of KSI-301 recipients but none of those given Eylea. On a conference call today Kodiak’s management insisted that the Daylight trial, due to report in a year or so, could yet save the project. But this tests monthly dosing – more frequent than Eylea’s standard regimen – so is unlikely to help KSI-301’s commercial prospects even if it succeeds. The group says the $731m it had at the end of last year will give it a two-year runway, which will get it to the Daylight readout and those of the Gleam and Glimmer trials in diabetic macular oedema. But for Kodiak and the host of others working on long-acting AMD projects the lesson ought to be simple: it is very difficult to out-Eylea Eylea. 

Kodiak's phase 3 programme for KSI-301
Trial Indication KSI-301 dose Control Results
Dazzle Wet AMD 3 dose groups: every 3mth, 4mth & 5mth Eylea every 2mth Failed Feb 2022, also showed toxicity signal with KSI-301
Daylight Wet AMD Monthly Eylea every 2mth Data due Q1 2023
Beacon Retinal vein occlusion Every 2mth or longer Eylea every 2mth or longer Data due 2022
Gleam Diabetic macular oedema Every 2-6mth Eylea monthly, then every 2mth Data due Q1 2023
Glimmer Diabetic macular oedema Monthly, then every 2-6mth Eylea monthly, then every 2mth Data due Q1 2023
Glow Non-proliferative diabetic retinopathy Monthly, then every 2-6mth Sham Completes Oct 2023
Dazzle is ph2/3, all others ph3. Source: Evaluate Pharma, clinicaltrials.gov & company presentation. 
*Adjusted mean BCVA/CST change from baseline at year 1, averaged over weeks 48 and 52. Source: company presentation.

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