By Jim Shrine
NeoTherapeutics Inc. said its Neotrofin (AIT-082; leteprinim potassium) produced a "positive effect" on behavioral function and memory in a Phase IIa trial in Alzheimer's patients.
Patients with mild to moderate Alzheimer's were treated with one of three drug doses, or placebo, once daily for 28 days. The company plans to analyze data further and talk with the FDA before deciding how to proceed, Michelle Glasky, the company's vice president of scientific affairs, said, adding that a Phase IIb or Phase III study are possible routes.
"We are extremely encouraged by the results," Glasky said. "We feel this drug has a lot of potential. We continue with our development plans as aggressively as possible."
The 28-day study results follow the disclosure, made earlier this month, of data from a Phase Ib study that showed a statistically significant positive effect on memory function in healthy elderly volunteers after seven days of treatment.
Glasky said improvement in the patients was seen in the Phase IIa study as well, but the company would not comment on whether results were statistically significant. Because of the complex nature of such data, she said, disclosure of them is more appropriate in a scientific publication. Glasky did say there were positive findings on safety and memory improvement, and that the results support positive findings seen in Phase I.
Neotrofin is the company's lead compound. Preclinical studies showed the compound can control production of multiple natural neurotrophic factors and restore function in animal models of aging, brain injury and spinal cord injury.
"We feel this drug has the potential to treat patients in a different way than those on the market or in development," Glasky said. "That could be the reason we're seeing some effects [on memory and behavior] earlier than more traditional therapies."
The next targeted indication is spinal-cord injury, she said, with human studies possibly beginning by the end of the third quarter.
Glasky said NeoTherapeutics continues to discuss potential alliances with various companies. It also is exploring financing options, as it begins to draw on a $15 million equity line, she said.
NeoTherapeutics released the Phase IIa results Wednesday. Its stock (NASDAQ:NEOT) lost 62.5 cents that day, but gained it all back Thursday, closing at $10.75. n