PD03A / AFFiRiS - LARVOL DELTA

An update on immune-based alpha-synuclein trials in Parkinson's disease. (PubMed, J Neurol) - "Specifically, UB-312, AFFITOPE PD01A, PD03A and ACI-7104.056 are designed to provoke an immune response against α-syn (active immunisation), while Prasinezumab and Cinpanemab, MEDI1341 and Lu AF82422 focus on directly targeting α-syn aggregates (passive immunisation). Despite some promising results, challenges such as variable efficacy and trial discontinuations persist. Future research must address these challenges to advance disease-modifying therapies for PD around this therapeutic target."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

[VIRTUAL] Experimental Therapies for Rare Movement Disorders – MSA (EAN 2021) - P1, P2 | "In this regard, enhancing the clearance of α-synuclein via autophagy (transcription factor EB) or direct proteolysis (neurosin), inhibiting its aggregation (anle 138b and CLR01) or post-translational truncation (belnacasan), as well as active (Affitope PD01A) and passive immunotherapy (CD5-D5) have demonstrated beneficial effects on motor behavior, α-synuclein burden and other neuropathological readouts in transgenic MSA mice...These preclinical results have motivated the conduction of a phase I trial to evaluate the safety and tolerability of repeated administrations of specific active immunotherapy against α-synuclein with Affitope PD01A and PD03A (NCT02270489)...In this regard, a phase I trial to assess the safety and tolerability of anle138b in healthy volunteers is currently ongoing (NCT04208152). Additionally, a small phase II trial with exenatide (NCT04431713), an approved antidiabetic, is ongoing."

Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Lewy Body Disease • Movement Disorders • Multiple System Atrophy • Parkinson's Disease • Solid Tumor • Targeted Protein Degradation • CD5 • TFEB • TLR4

Safety and Tolerability of Active Immunotherapy Targeting α-Synuclein with PD03A in Patients with Early Parkinson's Disease: A Randomized, Placebo-Controlled, Phase 1 Study. (PubMed, J Parkinsons Dis) - "The safety profile and positive antibody response of PD03A supports the further development of active immunotherapeutic approaches for the treatment of PD."

Clinical • Journal • P1 data • CNS Disorders • Immunology • Movement Disorders • Parkinson's Disease

[VIRTUAL] ACTIVE AND PASSIVE IMMUNIZATION IN THE TREATMENT OF PARKINSON’S DISEASE (ADPD 2021) - "To obtain active immunization AFFITOPE PD01A/PD03A has been tested in patients and healthy controls...Passsive immunization has been tested using two human antibodies PRX002/RG7935, and BIIB054...BIIB054 is actually in phase IIb since 18 months, no significant side effects have been reported during the double blind phase and interim results on clinical end-points are expected. Two other studies are starting one with UCB compound and another study with PRX."

Alzheimer's Disease • CNS Disorders • Dementia • Lewy Body Disease • Movement Disorders • Parkinson's Disease

A Phase 1 Randomized Trial of Specific Active α-Synuclein Immunotherapies PD01A and PD03A in Multiple System Atrophy. (PubMed, Mov Disord) - P1, N=30; AFF009 (NCT02270489); Sponsor: Affiris AG: "Twenty-nine patients reported a total of 595 treatment-emergent adverse events (mild or moderate, n = 555; severe, n = 40). Treatment-related adverse events included 190 injection-site reactions typically observed in vaccination trials with similar per-subject incidence in the treatment groups over time....Titers and antibody responder rate (58%) were lower in the PD03A-treated group. In conclusion, both PD01A and PD03A were safe and well tolerated."

Clinical • Journal • P1 data • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease • Solid Tumor

AFFiRiS announces publication in Movement Disorders Journal of positive clinical results of a Phase 1 trial in early Multiple System Atrophy (Yahoo Finance UK) - P1, N=30; AFF009 (NCT02270489); Sponsor: Affiris AG; "AFFiRiS...today announced the publication of positive results of a phase 1 randomized, double-blind, placebo-controlled trial in Multiple System Atrophy (MSA) in the peer-reviewed Movement Disorders Journal (https://doi.org/10.1002/mds.28218)....The results of this 52-week phase 1 trial in 30 patients with early MSA showed that both immunotherapies, PD01A and PD03A, were safe and well tolerated after five subcutaneous injections."

P1 data • CNS Disorders • Multiple System Atrophy

Prions, the pipeline, and the latest in Parkinson disease (Medscape) - "The Canadian company Cynapsus Therapeutics is developing a sublingual formulation of apomorphine (a dopamine agonist), and IntecPharma is implementing an accordion pill of levodopa/carbidopa that would release the drug for about 8 hours and allow more controlled absorption by the duodenum. Finally, both Impax Rytary® and AbbVie Duopa® (levodopa /carbidopa intestinal gel) are now available in the United States....AFFiRiS is waiting to see the results from PD03A and the exploratory data on the antibody response for this compound before selecting the best candidate to test in a phase 2 clinical trial (efficacy)."

Launch US • Pipeline update • Parkinson's Disease

AFF011: Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's Disease (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Affiris AG; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Gene Therapies • Parkinson's Disease