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news.Aeolus Pharmaceuticals has initiated a follow-on Phase I open label compassionate use multiple dose study of AEOL 10150 in a patient diagnosed with progressive and debilitating amyotrophic lateral sclerosis, also referred to as ALS or Lou Gehrig's disease.
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The study is being conducted at University of California, Los Angeles by Martina Wiedau-Pazos and is designed to evaluate the safety and efficacy of AEOL 10150 in an ALS patient over an extended period of time. The patient will receive a subcutaneous injection of 75mg of AEOL 10150 two times each day for up to 24 weeks. Efficacy and safety data will be monitored in real time for the duration of the study.
The primary objective of this study is to assess the clinical efficacy of AEOL 10150 with respect to the patient’s baseline assessment of functional status. Secondary objectives include the assessments of muscle strength, respiratory function, quality of life and safety.
The new study will build on results from a Phase I single dose study and Phase I, six and half day study already completed in patients with ALS. In the single dose study, all six single doses (3, 12, 30, 45, 60 and 75mg) were well tolerated with no serious adverse events, no significant laboratory abnormalities and no cardiovascular issues related to AEOL 10150.
The results of the Phase I multiple dose study showed that AEOL 10150 at doses up to 2mg/kg/day was safe and well tolerated with an excellent pharmacokinetic profile in ALS subjects, said Aeolus.
John McManus, president and CEO of Aeolus, said: “We are excited to get this study running, as it will provide the company with important longer-term safety data for AEOL 10150, which will be useful for future potential development in both ALS and radiation therapy.”