MODAG Initiates First-in-Human Phase 1 Clinical Trial for Anle138b

MODAG, a German biotechnology company focused on the development of disease-modifying small molecule therapeutics for neurodegenerative diseases, today announced the clinical trial initiation of, and recruitment for, a first-in-human Phase 1 study of lead candidate, anle138b in healthy volunteers. The compound is initially being developed for the treatment of Multiple System Atrophy (MSA), with the potential to be applied to other synucleinopathies,such as Parkinson’s disease, in the future. MODAG also recently secured a U.S. patent for anle138b, expanding the Company’s patent estate for anle138b to exclusive, worldwide coverage.

“Obtaining global patent protection for anle138b while beginning clinical testing in healthy individuals not only marks a significant strategic progression of our pipeline, but also emphasizes our ability to act on our corporate vision and goals. With the start of this trial, we are on track to run the tests necessary to bring anle138b one step closer to patients,” said Dr. Torsten Matthias, CEO of MODAG.

Anle138b is a small molecule compound that specifically binds toxic oligomeric structures of alpha-synuclein, the core aggregating protein in Parkinsonian disorders, preventing new oligomers from forming and blocking the aggregation process from advancing. As a primary objective, the study will evaluate the safety and tolerability of the compound in healthy volunteers. Secondary objectives include the analysis of the pharmacokinetic profile as well as dose-finding evaluations of single and multiple ascending doses of anle138b. Recruitment into the trial, which will be conducted by Quotient Sciences in Nottingham, UK, is underway. Anle138b will be administered orally as a single agent to healthy volunteers.

“Anle138b has the potential to become a tangible treatment option to stop MSA, a highly underserved indication, in its tracks. MSA patients are severly impacted by progressing movement, balance and autonomic function impairments and as with many neurodegenerative diseases, there are no disease-halting treatment options available. If successful, the Phase 1 trial also opens the opportunity for MODAG to investigate anle138b in other Parkinsonian disorders and Parkinson’s itself,” added Dr. Johannes Levin, CMO of MODAG.