Oncopeptides has announced measures the company is taking in response to the global spread of the novel coronavirus (COVID-19) pandemic.
Most importantly, the phase 2 HORIZON study will not be affected and FDA submission plans are on track for a filing late Q2. The phase 3 OCEAN study with 423 out of 450 planned patients enrolled will remain open for patient enrolment. Topline results are expected to be only slightly delayed, states the company.
Recruitment for other ongoing clinical studies will be put on temporary pause for patient safety reasons, including the phase 2 ANCHOR and BRIDGE studies and the recently started AL Amyloidosis study. The initiation of new studies including LIGHTHOUSE is expected to be delayed. Treatment will continue for all patients currently enrolled in clinical studies.“Obviously the COVID-19 pandemic has an enormous impact on us and society as a whole.
“We are very fortunate that this does not slow down our application process for accelerated approval in US and will not delay us in our effort to bring melflufen to the myeloma patients. We are equally fortunate that recruitment in OCEAN has remained relatively strong the last few weeks and we have enrolled sufficient number of patients to assess our primary endpoint in the future. The COVID-19 public health crisis does not decrease the medical need of myeloma patients and I firmly believe that melflufen has the potential to offer a new option to those with few available treatments. The safety and well-being of our patients continues to be our top priority and we will continue to take appropriate actions if need be to ensure their safety,” says Jakob Lindberg, CEO, Oncopeptides.
Photo of Jakob Lindberg: Oncopeptides