Ohr Pharma Applies a Ton of Lipstick to Squalamine Pig
Ohr Pharmaceuticals (OHRP) applied some serious spin Tuesday to conceal horribly negative results from a phase II study of its Squalamine eye drop. The failure of the study was buried in the fifth paragraph of Ohr's press release.
Let's rewind and recall what the Ohr bulls (scant in numbers) were saying heading into today's results: Squalamine, a failed injectable drug for wet age-related macular degeneration, had been magically reformulated into a more convenient eye drop formulation. Ohr's phase II study was going to show conclusively that dripping Squalamine into the eye of wet AMD patients would significantly reduce the frequency of Lucentis injections. Drugs like Roche's (RHHBY) Lucentis and Regeneron Pharma's (REGN - Get Report) Eylea are very effective treatments for wet AMD but require regular injections into the eye, which no one enjoys for obvious reasons.
Squalamine bombed. The frequency of Lucentis injections -- the primary endpoint of the Ohr study -- was unchanged. On average, wet AMD patients treated with Squalamine required 6.2 Lucentis injections compared to 6.4 Lucentis injection for the placebo-treated patients. Squalamine made no difference at all.
As I said above, Ohr buried the failure of the study in the fifth paragraph of today's press release. Class act, fellas!
Instead, Ohr spends four-plus paragraphs of the release spouting off nonsense about how Squalamine improved the visual acuity of wet AMD patients enrolled in the study. Don't believe the B.S. for a millisecond, this is just the spin necessary to keep the company's lights on through another desperate financing cycle. Dilution, like winter, is coming.
The data demonstrated a positive benefit in visual function across multiple clinically relevant endpoints, including a mean change in visual acuity at the end of study visit for the interim analysis group of +10.4 letters with Squalamine eye drops plus Lucentis(R) PRN versus +6.3 letters in the placebo eye drops plus Lucentis PRN arm, a 65 percent additional relative benefit (p=0.18).
Oh my. In other words, Squalamine delivered a 4.1-letter improvement over placebo. Let's award the Nobel Prize! The 65% relative improvement is a cheap statistical stunt. Look at the p value of 0.18. Failure. This is nowhere close to being clinically meaningful.
The rest of Ohr's claims on the squalamine results are data-dredging at its worst.