Seattle's Omeros Fires Back But Still Won't Answer Basic Questions About Key Drug

August 24, 2017
By Alex Keown, BioSpace.com Breaking News Staff

SEATTLE – Omeros Corporation is firing back at critics of its lead drug candidate OMS721, which includes Adam Feuerstein of Stat News, as well as an online short seller posting under the pseudonym “Art Doyle.”

In a press release issued Wednesday, Seattle-based Omeros said it is pursuing legal action against the individual or individuals who issued a “series of defamatory reports” about the company. On Twitter, Doyle described himself (assuming it’s one person) as having “Expertise in immune oncology, statistics and James Beard award winning restaurants.” The Doyle posts issued earlier this summer raise questions of safety and financial resources of the company.

Omeros said it is attempting to unmask anyone behind the Doyle name. The Doyle reports lead into the company’s issues with Feuerstein, who has published criticisms of the company and its lead product, OMS721, being developed to treat atypical hemolytic uremic syndrome, a rare and life-threatening disease.

In a report published earlier this week, Feuerstein said Omeros would not provide answers to questions about its clinical data including how many patients were included in trials, and whether or not there is proof the drug is effective when it is administered subcutaneously opposed to a drip, which Feuerstein said is a key selling point Omeros has used.

This morning Omeros said its refusal to answer Feuerstein was related to its attempts to unmask Doyle. The company said Feuerstein evidently had “early access to and commented through Twitter on the initial ‘Art Doyle’ false report before it was broadly made public.” However, with share prices in decline, Omeros said it was responding through a one-time press release to “correct some of the inaccuracies” in Feuerstein’s reporting.

As of June 30, 2017, 54 patients had been enrolled in OMS721 Phase II clinical trials, the company said. Omeros said enrollment numbers have continued to increase throughout the summer, but did not provide a more recent number of patients. The company did say that it disclosed earlier in August that 150 subjects have been dosed and added that number will continue to increase. In March, Omeros announced enrollment had opened for its Phase III clinical trial evaluating OMS721 in patients with atypical hemolytic uremic syndrome. The company said in its release that the trial, scheduled to begin later this year, will have approximately 80 patients and a data readout is expected in 2020. An interim analysis will be conducted following treatment of approximately 40 patients, the company added.

In its statement, Omeros also pointed to data issued in 2014 regarding subcutaneous injections. Omeros said subjects in a Phase I trial were successfully dosed both subcutaneously and intravenously at multiple levels. “Since then, several cohorts of subjects have been administered repeated subcutaneous doses of OMS721, yielding comprehensive pharmacokinetic/pharmacodynamic (PK/PD) data,” the company said.

Late Wednesday though, Feuerstein said that data has not been released. He said the company is still not providing answers to his basic questions. Feuerstein also noted that Omeros used the term subjects as opposed to patients. Subjects, Feuerstein said, could include healthy individuals as well as those diagnosed with an illness.

Feuerstein said the company has not disclosed if its subcutaneous predictions are backed up by data. He said the company’s Phase II data all described the drug being administered intravenously.

“Omeros had an opportunity to clear up the controversy on Wednesday, but the company chose not to,” Feuerstein said. When the Doyle posts first went live in July, share prices dropped about 10 percent. They began to rise again throughout the month of July, but in August began sinking again. This morning are trading at $20.88 as of 11:21 a.m.