Wednesday, October 27, 2021
Teva Pharmaceutical Industries Ltd. and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG's lead compound anle138b and a related compound, sery433.
Anle138b targets pathological alpha-synuclein oligomers and is being evaluated in patients with neurodegenerative diseases for potential disease modification. Under the terms of the agreement and pending regulatory clearance, Teva will receive an exclusive global license to develop, manufacture and commercialize anle138b and sery433. The companies will jointly develop the compounds for the multiple system atrophy (MSA) and Parkinson’s disease (PD) indications based on early-stage clinical studies, and consider exploring additional indications based on clinical outcomes.
A Phase 1 (NCT04208152) study examining anle138b in healthy volunteers completed in July 2020 demonstrated favorable benefit-risk profile at all dose levels while achieving higher plasma levels than those required for full therapeutic efficacy in animal models. Anle138b was initially developed in patients with MSA and PD and has the potential to be applied to other neurodegenerative disorders, such as Alzheimer's disease. A Phase 1b (NCT04685265) clinical trial evaluating the safety of the compound, as well as efficacy measures in patients living with PD, is currently being conducted.
“With Teva’s strong foundation in neuroscience and our in-house expertise in neurology and psychiatry, this licensing and collaboration agreement adds a promising new compound to our early-stage pipeline as a possible orphan disease treatment for the growing patient population living with multiple system atrophy, as well as a potential option for patients living with Parkinson’s disease,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D. “We at Teva are excited about collaborating with the MODAG team and look forward to future developments as we continue to follow the science and explore additional indications for both partnered compounds.”
Dr. Matthias, CEO of MODAG added, "We are pleased to partner and work alongside Teva, an organization that has longstanding, extensive expertise in the development of therapeutics. In addition to the previous support we have received from the Michael J. Fox-Foundation and the Cure Parkinson's Trust, this partnership further underscores the heightened potential of our lead candidates to do what no drug is currently capable of: blocking the progression of synucleinopathies. Building upon our notable preliminary results, we look forward to the continued development of anle138b alongside Teva to help patients living with currently untreatable neurodegenerative diseases, including MSA, PD and Alzheimer’s disease. With the introduction of small-molecule medication, we open a new chapter in the fight against neurodegenerative diseases and have the chance to improve the lives of millions of patients drastically.”
Multiple System Atrophy
Multiple system atrophy (MSA) is a rare neurodegenerative disorder classified clinically as "atypical parkinsonism" and belongs to the group of synucleinopathies. MSA is characterized histopathologically by abnormal deposits of the α-synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells. Typically, there is a dysfunction of the autonomic nervous system, i.e., disturbances of bladder function, erectile function, intestinal mobility, or the regulation of blood pressure in combination with a movement disorder. The movement disorder often presents with either Parkinson-like symptoms or a disturbance of cerebellar function, such as ataxia, gait and speech problems. In the US, EU, and Japan, MSA affects about 40,000 people (prevalence of 4 per 100,000), with about 6,000 new cases diagnosed each year (incidence of 0.6 per 100,000). Post-diagnosis life expectancy is about 7-10 years. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path. This unmet medical need for MSA disease modification is the driver to develop new therapies that could potentially impact the lives of patients.