Ovid Therapeutics will modify its ongoing Phase 2 trial of OV101 to add adolescents with Angelman syndrome aged 13 and older to the adults it continues to recruit.
The decision came after a Phase 1 trial showed that adolescents process the drug the same way adults do, suggesting it will be safe for them as well.
Adding adolescents to the STARS study (NCT02996305) will push its expected completion date back to the second half of 2018, Ovid said. Adults or adolescents who want to enroll in the trial can find more information here.
“We have assembled a team at Ovid that not only has deep expertise in neurology but also significant experience developing therapies for children,” Jeremy Levin, the company’s CEO, said in a press release. “Part of our core strategy is to rapidly develop our medicines for younger patients, which is a patient population usually addressed late in the drug development process.”
Although researchers have gathered safety information on OV101 from more than 4,000 adults, a recently completed Phase 1 trial was the first time the drug had been tested in adolescents. The study included youngsters with either Angelman or Fragile X syndrome.
In addition to OV101’s safety, the study (NCT03109756) examined adolescents’ ability to tolerate the drug, and its pharmacokinetics, or how the drug behaves in the body.
The trial showed the therapy’s safety, tolerability and pharmacokinetics to be the same in adolescents as in adults.
“This first clinical data of OV101 in adolescents in genetically defined disorders with GABA hypofunction provide important information to our overall development strategy and are an important step to enable development of OV101 in younger ages,” said Amit Rakhit, Oval’s chief medical officer. GABA is a protein receptor whose inability to function at a required level is associated with Angelman.
Since Angelman syndrome is a developmental disorder, it is crucial to include younger patients in the testing of treatments, Ovid said. A development disorder is one that impairs a person’s development in childhood.
“At Ovid, we strive to provide access to effective therapies as early as possible and we are now able to offer enrollment in our STARS trial to adolescent Angelman syndrome participants,” Rakhit said.