Cyclo Therapeutics launches phase 2b study for early Alzheimer’s disease drug
Cyclo Therapeutics announced that a phase 2b study for its investigational drug Trappsol Cyclo, which targets the reduction of amyloid beta and tau in the treatment of early Alzheimer’s disease, is now underway.
According to a Cyclo Therapeutics press release, the phase 2b study is a 6-month multicenter, randomized, placebo-controlled, double-blind study evaluating the safety, tolerability and possible efficacy of monthly Trappsol Cyclo (hydroxypropyl beta cyclodextrin) infusions in patients with early AD.
“The pathophysiology of AD is complex, and the relative contributions of the various pathogenic changes leading to disease progression warrant tailored therapies,” Cynthia A. Lemere, PhD, senior advisor for Cyclo’s Alzheimer’s disease asset, said in the release. “Therefore, it is essential that we continue to evaluate novel investigational drugs such as Trappsol Cyclo. This important and well-designed study is expected to provide critical information.”
Approximately 120 patients in the U.S. will be enrolled in the study, the release stated, and randomized across three study groups: 500 mg/kg or 1,000 mg/kg doses of Trappsol Cyclo and a placebo. The trial will include a screening period, followed by a treatment period up to 24 weeks and a follow-up safety period.
“[This] investigational drug shows promise in AD, based on the drug’s ability to stabilize disease progression in an AD patient,” the trial’s principal investigator and professor emeritus of neurology at Indiana University School of Medicine, Martin R. Farlow, MD, said in the release. “Notably, the ability of Trappsol Cyclo to gain access to the cerebrospinal fluid/brain and impact CSF tau and serum 24Shydroxycholesterol when intravenously administered are most impressive and represent an exciting avenue for therapeutic development.”
“We are pleased with the continued progress with our clinical development program for our Alzheimer’s disease asset,” Cyclo CEO N. Scott Fine said in the release. “The commencement of this study and initiation of patient enrollment demonstrates our commitment and strategic execution utilizing Trappsol Cyclo as a potential treatment option for patients and families who have been impacted by this devastating disease.”
According to the release, the biotechnology company also is testing Trappsol Cyclo in a phase 3 clinical trial and long-term extension study for the treatment of Niemann-Pick disease.