Biotech upstart touts biomarker effect in PhI ALS study

A small Palo Alto, CA-based biotech has garnered some fresh attention for itself after touting the results of a small Phase I study designed to test its lead drug by measuring its impact on a key biomarker for Lou Gehrig's disease, or amyotrophic lateral sclerosis.

While most developers focus their Phase I studies entirely on safety and tolerability, Neuraltus chose to also gauge the fluctuation of blood levels of the biomarker - which was not disclosed - 24 hours after dosing. The developer, which the San Francisco Business Times notes is hoping to use the data to help woo new investors, recruited 32 patients for the study.

Investigators concluded that the drug, NP-001, not only produced the desired effect on the biomarker, it also demonstrated safety and tolerability. Neuraltus, which raised funds in early 2009, says the therapy could be effective for a range of CNS ailments.

"NP001 appears to have affected the level of a biomarker directly related to ALS pathogenesis in a dose-dependent manner," said Robert G. Miller, M.D., the study's principal investigator and Medical and Program Director of the Forbes Norris MDA/ALS Research Center. "This is extremely promising and is virtually unprecedented in ALS research. In addition, the safety profile of NP001 is very reassuring and gives us confidence going into the Phase II clinical study."

- here's the press release
- here's the story from the San Francisco Business Times

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