MODAG, a German biotechnology company focused on the development of disease-modifying small molecule therapeutics for neurodegenerative diseases, announced the clinical trial initiation of a first-in-patient Phase 1b study for anle138b in patients with mild to moderate Parkinson′s Disease (PD).

Anle138b is a disease-modifying treatment option for synucleinopathies, such as Multiple System Atrophy (MSA) and PD.

The short-term Phase 1b study with PD patients will be conducted by Quotient Sciences in Nottingham, UK, supported by the Neurology Department of Nottingham University Hospital. The study’s primary endpoints include safety, tolerability and pharmacokinetics of anle138b in PD patients in order to establish the optimal dosing scheme for future long-term efficacy trials. The trial is supported by a grant of USD 1.4 million from The Michael J. Fox Foundation for Parkinson’s Research.

“After successfully completing our first-in-human clinical trial for anle138b in healthy volunteers in August, we are excited to launch the first-in-patient study in line with our ambitious development plan timelines. We are proud to have reached the significant milestone of bringing anle138b to patients for the first time and see this as a validation of our ability to act on our corporate visions and goals,” said Dr. Torsten Matthias, CEO of MODAG.

Professor Armin Giese, CSO of MODAG, continued, “Anle138b is a small molecule capable of binding to alpha-synuclein’s toxic oligomeric structures and thereby blocking disease-progression. The recently completed Phase 1 study confirmed excellent safety and tolerability of anle138b in healthy human volunteers. From initially developing this molecule I am very excited to see it reach patients so rapidly with this first study in Parkinson′s Disease.”

Professor Johannes Levin, CMO of MODAG, added: “Anle138b demonstrates the potential to become a tangible treatment option for halting disease progression in PD and MSA. The data collected in this study will serve as the foundation for its continued clinical development and will inform the design of future long-term efficacy studies in patients. I am pleased with the rapid progress we have made in bringing our lead candidate to patients.”