What matters most? Acuity or duration… What are your thoughts my friends?Three months ago I offered my thoughts on this question but I’m happy to repost….
The current US$3.1 bn market cap for Kodiak shocked me. When PYC (another ASX biotech in which I'm invested) compared itself with Kodiak less than 6 months ago, Kodiak’s market cap was just US$580m .
I note that Kodiak's stock price first rose in September, after Phase 1b results were released which supported 3, 4 and 5 month long-interval dosing of Kodiak’s lead drug, KSI-301, in wAMD.
But the really big jump happened in early December after Baker Bros agreed to pay US$225 m for future royalties which was immediately followed by a further raising of US$317m.
But, even allowing for the fact that Kodiak has much more cash on hand, there is still an enormous disparity in valuation between the two companies.
I guess the key issue is deciding where most value lies. Durability or efficacy?
KSI-301 appears to significantly stretch out dosing intervals compared with current treatments. The Phase 1b wAMD trial results released late last year showed 84% of patients lasted 4 months or more before retreatment while 55% lasted up to 6 months.
On the other hand, OPT-302 appears to have the advantage of superior efficacy compared with current treatments or with KSI-301. At 16 weeks, KSI-301 demonstrated a change from baseline in mean BCVA of 5.4 letters and change in CST from baseline of µM 72. This compares with OPT-302 Phase 2b results in which a 4-weekly dosing regimen of 2mg OPT-302+ranibizumab (Lucentis) demonstrated a mean change in BCVA from baseline of ~14 letters at 16 weeks. There was a mean change from baseline in CST of µM 146.7 at 24 weeks. Aflibercept (Eylea) dosed at 2 monthly intervals has demonstrated a change in BCVA of approximately 7 letters at 16 weeks.
Dr Pravin Dugel (Principal Investigator) offered his thoughts on the durability v. efficacy question during the Conference Call that followed the release of Opthea’s Phase 2b wAMD results. For him, improving efficacy wins hands down.
I'm old enough to have seen the entire anti-VEGF-A renaissance and revolution. I know the impact that that's had on my patients, but I'm also objective enough to know what the unmet needs are, and if anybody were to say, "What is the largest unmet need," it would be efficacy. There's no doubt about that whatsoever. Durability is important, sustainability is important but there's nothing that's more important, or more challenging, or higher bar, than efficacy. It matters to my patients whether they can drive. It matters to my patients whether they can read their chequebooks.
It matters to my patients whether they can live independently and cook and walk, et cetera. That's extraordinarily important. And if there's a drug that I can give my patients to improve efficacy and allow them those privileges that they're used to, of living independently, of driving, of being able to write a letter, of being able to email, of being able to walk and look at the computer; that's a huge, huge improvement in their quality of life. So, this medication potentially would be able to improve the quality of life in all of my patients and fit an unmet need that is the largest unmet need that we have. So, that is how I look at all this from a clinician perspective….And I’m really happy that we have a drug here that has the potential to allow us to go beyond that bar that's been set. This is really the first trial that I know of in a very, very long time or historically that has actually improved the efficacy of anti-VEGF-A monotherapy. And that is a much, much more difficult task, a much higher bar than improving durability.And note that there's still a potential, certainly, of improving durability because if you improve efficacy it would make sense that you'd have to treat less….http://ir.kodiak.com/static-files/245a244d-2400-48d0-9851-55317d1f040bhttps://hotcopper.com.au/threads/ann-opthea-presentation-for-euretina-congress.4950089/#.XkMz62gzaUkhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125387s061lbl.pdfhttps://www.opthea.com/wp-content/u...Wet-AMD-Clinical-Trial-10001623-070819_V2.pdf
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