Novo Nordisk has ended one of the multiple trials testing the lead oral drug from its $1.1 billion Forma Therapeutics buyout, according to an update to the US federal trials database this week.
The Danish drug giant terminated a Phase 2 trial of etavopivat for anemia in adults with various forms of myelodysplastic syndromes, or MDS, according to an update to the US clinical trials site on Thursday. In patients with MDS, red blood cells don’t mature or become healthy ones, and the cancer can progress into leukemia.
The drug is still being tested in mid– and late-stage trials for patients with sickle cell disease and thalassemia.
Novo made the decision after a “futility assessment concluded low likelihood of the trial showing meaningful patient benefit,” according to an update to the Fortitude trial registry.
“This decision was not taken lightly and reflects a judgement of low likelihood that the Fortitude trial would generate benefit for patients with MDS,” a Novo spokesperson said in an emailed statement to Endpoints News.
MDS wasn’t highlighted in Novo’s deal announcement in fall 2022, but it was nonetheless another patient population that the pharmaceutical company had hoped to treat with the selective pyruvate kinase-R activator.
Patients with sickle cell disease and thalassemia are the main populations for which Novo is developing the once-daily medicine.
“We remain confident in etavopivat’s promise and are committed to its continued development in sickle cell disease (SCD) and thalassemia,” the spokesperson said. “The termination of the Fortitude trial does not diminish our belief in etavopivat’s potential to make a significant impact on patients’ lives.”
Novo highlighted the asset’s potential in MDS in its annual report in January.
Agios Pharmaceuticals is also testing a PK activator, dubbed tebapivat, for MDS-associated anemia. Agios’ more advanced PK activator, mitapivat, is approved for adult PK deficiency and marketed as Pyrukynd. Bristol Myers Squibb’s Reblozyl is indicated for MDS-related anemia.
Since the acquisition, Novo has offloaded some of the pipeline at Forma, a drug developer that had touted “the science of giving a damn.” It sold a preclinical cancer candidate to Debiopharm and a Phase 1 prostate cancer drug to Pathos AI.