Top-line results from Ohr Pharmaceuticals’ (OHRP) phase II IMPACT study, testing its squalamine eyedrops in age-related macular degeneration (wet-AMD), had a crushing effect on the stock Friday. ORHP dropped from $8.75 at Thursday’s close to $3 on Friday.
The 9-month Phase II IMPACT study evaluated twice daily OHR-102, an eyedrop administered in combination with the standard AMD therapy Lucentis, versus placebo eye drops with Lucentis. The study missed its primary endpoint – change in mean number of Lucentis injections between the treatment arms.
This was not entirely unexpected, as OHRP released interim results from the IMPACT study in 2014 indicating that the primary endpoint would be a miss. At the time, however, the company pointed to an improvement in visual acuity for the small number of patients enrolled at the interim who were receiving the squalamine/Lucentis combination.
Now, OHRP is changing the story entirely. It appears that in the total patient group, the visual acuity benefit seen at the interim has not held up. On Friday, OHRP pointed to a subset of the study population, patients with classic containing choroidal neovascularization (CNV) receiving the OHR-102/Lucentis combination. 42% of these patients demonstrated a >=3 line gain at nine months, compared to 28% in the Lucentis monotherapy group.
Investors are selling OHRP not because the primary endpoint missed – this was expected based on the interim analysis – but because Ohr is now touting a subset analysis quite different from that at the interim, and blaming the change on a differing patient population in the 2nd half of the study. Investors know that the subset analysis rarely plays out in larger studies, and Ohr’s history is already steeped in controversy. The company plans to move forward with a phase 3 program later this year.
