Sneaking in the bad news after hours on a Friday (a Bio-Twitter bugbear) still wasn’t under the radar enough to help stop the hemorrhaging of GlycoMimetics’ shares.
The bad news: Its pivotal phase 3 sickle cell disease asset rivipansel, being developed by Pfizer in a deal dating all the way back to 2011, failed its primary and key secondary endpoints in the so-called RESET trial.
This test was set up to see how well and how safely rivipansel, a pan-selectin antagonist, worked in patients aged 6 and older with sickle cell disease who were hospitalized for a vaso-occlusive crisis and required treatment with IV opioids.
The primary endpoint was time to readiness-for-discharge and the key secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids, all of which the drug failed to hit.
“We are both surprised and deeply disappointed by this outcome, as we had strongly hoped that rivipansel would have a positive benefit for people living with sickle cell disease,” said Rachel King, CEO of GlycoMimetics, in a very brief release. “We are grateful to the many people who supported and advanced this program over the years of clinical study, especially to sickle cell patients and their families.”
GlycoMimetics saw its shares in the red by 42.5% in after-hours trading Friday night on the news, with a market cap of under $400 million.
Pfizer penned the $340 million pact with GlycoMimetics back in 2011 for the experimental drug, then called GMI-1070.
Analysts at Jefferies, who had “leaned toward being positive” on the data, looked elsewhere in the pipeline for positives in a note to clients this morning: “Oncology portfolio moving forward, with next readout for uproleselan (upro) in YE’20: During Q2 earnings call, mgmt. announced continued progress in PIII AML trials for upro. GLYC-sponsored trial in R/R AML patients is on track, with more sites being activated across US, EU and Australia.
“Two investigator-sponsored trials in 1L AML are also advancing. NCI-sponsored PIII trial in fit patients initiated enrollment in Q2 '19 while HOVON PII study in unfit patients is finishing up start-up activities and will start recruiting soon. However, the first top-line data readout for upro is not expected until late ’20, leaving a void in near-term catalysts. GLYC also plans to start a PIb POC trial for GMI-1359 in breast cancer patients with bone metastasis.”