BaroFold has started a two-stage Phase I, repeat dosing, single-center, double-blinded study in up to sixty healthy volunteers to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of BaroFeron.
In preclinical studies BaroFeron demonstrated enhanced pharmacological properties, both pharmacokinetics and pharmacodynamics, when compared to commercial interferon beta products.
According to the company, BaroFeron has the potential to offer significant benefits to multiple sclerosis patients as these properties have been demonstrated to correlate with lesion formation by magnetic resonance imaging measurements and clinical exacerbations.
Lyndal Hesterberg, president and CEO of BaroFold, said: "Our goal is to have BaroFeron for multiple sclerosis in late-stage clinical trials and advance two additional two pipeline products targeting allergic asthma and rheumatoid arthritis in the clinic by the end of 2010."
From their site:
BaroFeron is a proprietary recombinant human interferon beta being developed for the treatment of Multiple Sclerosis. Interferon beta products are considered the ‘gold’ standard for first line treatment options for managing the progression of Multiple Sclerosis. However, clinical evidence and physician surveys indicate the need to improve upon the efficacy and safety of currently available therapies. BaroFeron will be differentiated from other interferon-beta products by improved safety and greater bioavailability enabled by BaroFold's proprietary PreEMT technology. BaroFold is aggressively implementing our clinical and regulatory strategy in preparation for a rapid launch.