Alzamend Neuro submits IND for bipolar disorder therapeutic

Key takeaways:

• A phase 2a study of AL001 for Alzheimer’s disease established a maximum tolerated dose unlikely to require therapeutic drug monitoring.
• Future development of AL001 may be eligible for additional FDA approvals.

A clinical-stage biopharmaceutical company has announced the submission of an investigational new drug application to the FDA based upon results of a phase 2a clinical study of a novel lithium delivery system, AL001, for bipolar disorder.

According to a release from Alzamend Neuro, results from its recently completed phase 2a multiple-ascending dose trial of AL001 in healthy volunteers for Alzheimer’s disease identified a maximum tolerated dose, which was assessed by an independent safety review committee.

The maximum tolderated dose was set at a lithium carbonate equivalent dose of 240 mg three times per day. The dose is unlikely to require therapeutic drug monitoring, per the release, as it is designed to distribute more lithium to the brain at lower systemic exposure, which is likely to result in a better safety profile compared to available lithium salts.

“This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline,” Alzamend CEO Stephan Jackman said in the release. “We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”

Once the IND is cleared by the FDA, Alzamend plans to initiate a phase 2a study to determine relative increased lithium levels in the brain compared with a marketed lithium salt in those with bipolar disorder.

The company further stated its goal of replacing a 300 mg, three-times-daily lithium carbonate dose for treatment of bipolar disorder with a 240 mg AL001 lithium equivalent, a planned 20% reduction of lithium for those in need. As a result, Alzamend may recommend the program for the 505(b)(2) pathway of FDA approval, which is granted to novel formulations of an already-approved drug.