Benzinga | Apr 20, 2021 09:29AM EDT

Cyclo Therapeutics To Proceed With IND Filing For Phase 2 Trial Using Intravenous Trappsol Cyclo In Alzheimer's Disease

FDA feedback supports Company's Phase 2 development strategy for Alzheimer's disease asset; IND filing on track for H2 2021

Cyclo Therapeutics, Inc. (NASDAQ:CYTH) ("Cyclo Therapeutics" or the "Company"), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, today announced that it has received feedback from the U.S. Food and Drug Administration ("FDA") supporting the Company's development strategy to submit an initial new drug application ("IND") application for a Phase 2 study of Trappsol(r) Cyclo(tm) in the treatment of early Alzheimer's disease, following a positive Type B interaction.

"We are encouraged by the feedback and recommendations from the FDA and are grateful for their support of our proposed Phase 2 development strategy for Trappsol(r) Cyclo(tm) in the treatment of Alzheimer's disease. This interaction was an important step forward for our Alzheimer's disease program as we move forward with the filing of our initial IND. We are looking forward to supporting the advancement of this asset and the potential to bring an important treatment option to patients," commented Michael Lisjak, Chief Regulatory Officer, Senior Vice President for Business Development of Cyclo Therapeutics.

The Company is currently advancing its lead product candidate of Trappsol(r) Cyclo(tm) in a pivotal Phase 3 study for the treatment of Niemann-Pick Type C (NPC1), expected to commence this quarter. Cyclo Therapeutics' Alzheimer's disease program is the second pipeline candidate program generated from the Company's platform technology. The Company is on track to file its IND for a Phase 2 study of Alzheimer's disease in the second half of this year.

N. Scott Fine, CEO of the Company added, "The Cyclo Therapeutics team continues to make fundamental progress on all fronts, and I am very pleased with the outcome of our FDA interaction. We believe our Alzheimer's disease asset has potential as a disease modifying treatment and look forward to identifying the best strategic partner to advance this important program. Our focus and priority remain on advancing our pivotal Phase 3 study of Trappsol(r) Cyclo(tm) towards approval to address the needs of the NPC community."

As previously announced, the Company filed an international patent application titled "Methods for Treating Alzheimer's Disease," published as International Publication Number: WO 2020/092107 Al.