Discussion from the same entry at clinicaltrials.gov:
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Expected Total Enrollment: 100
Study start: February 2007
MM-093 is a non-glycosylated, recombinant form of human alpha-fetoprotein (hAFP) that is manufactured using a transgenic goat system. Pre-clinical data from rodents and non-human primates demonstrated that MM-093 is well tolerated and is not associated with significant toxicity. A Phase 1 study of MM-093 in healthy volunteers has been completed which suggested that MM-093 was well tolerated, with an adverse event profile that was similar to placebo.
The pharmacokinetic profile of MM-093 in healthy volunteers demonstrated dose-proportionality of serum levels and a half-life of approximately 5 days, which suggested an optimal target dose of 2-60mg.
A double-blind, placebo-controlled Phase 1b trial in adult patients with active rheumatoid arthritis while on stable doses of methotrexate has been completed as well. Similar to the Phase 1 study, the adverse event profiles were similar between the active and placebo groups. There also appeared to be evidence of biological activity in this study, suggesting that MM-093 may be beneficial in patients with RA.
An exploratory Phase 2 dose-ranging study assessing 2.5, 7.5 and 20mg of MM-093, compared to placebo, in adult patients with active rheumatoid arthritis despite treatment with methotrexate, was recently completed. 259 patients were enrolled at 39 sites in the US. In this study, MM-093 was safe and well tolerated across all dosing groups. There were a total of 20 SAE’s, but only one was considered related to study drug and it was in the placebo group. Although the primary endpoint of ACR20 response rate was not achieved in this study (39.4% ACR20 in 20mg group vs 30.4% ACR20 in placebo group), there were trends towards improvement in multiple secondary endpoints. Furthermore, the sub-group of patients with less than 2 years RA duration achieved statistically significant improvements in ACR20, levels of disease activity and EULAR responses.
As a result, it appears 20mg may be at the low end of the therapeutic dosing spectrum and higher doses need to be tested in future trials Therefore, an additional study will be undertaken to test 60mg versus placebo in adult patients with active RA despite treatment with MTX.
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