Granted Patent
B2
US 12,595,295 · App. 16/936,457 · Granted Apr 7, 2026
Dosing regimes for treatment of synucleinopathies
Inventors:
Jay Soto (San Francisco, CA); Daniel Keith Ness (San Mateo, CA); Martin Koller (Rancho Santa Fe, CA); Diane Mould (Fort Myers, FL); Frank Boess (Basel, CH); Meret Martin-Facklam (Basel, CH); Valerie Cosson (Basel, CH); Hans Peter Grimm (Basel, CH); Ronald Gieschke (Basel, CH); Sara Belli (Basel, CH); Silke Weber (Basel, CH)
C07K16/18A61B5/0004A61B5/4848A61K9/0019A61K31/198A61P25/16A61P25/28C07K16/2857A61B5/11A61B5/1101A61B5/4082A61K2039/505A61K2039/545
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Abstract
The invention provides dosage regimes for treatment of synucleinopathies. In one regime, a subject receives 3000-5000 mg of an antibody intravenously every 3-5 weeks. In another regime, a subject receives 1300-1700 mg of an antibody intravenously every 3-5 weeks.
Claims (16)
1 . A method of treating or effecting prophylaxis of a subject having Parkinson's disease, comprising intravenously administering to the subject a dose of 1500 mg of an antibody or an antigen binding fragment thereof against alpha-synuclein at intervals of 3-5 weeks, wherein the antibody comprises a heavy chain variable region comprising SEQ ID NO:10, respectively, and a light chain comprising SEQ ID NO:5.
2 . The method of claim 1 , wherein the antibody comprises a heavy chain comprising SEQ ID NO:37 and a light chain comprising SEQ ID NO:32, wherein the C-terminal lysine of SEQ ID NO:37 may be absent.
3 . The method of claim 1 , wherein the antibody is of human IgG 1 isotype.
4 . The method of claim 1 , wherein the interval is 4 weeks.
5 . The method of claim 1 , wherein the subject receives the antibody every 4 weeks for at least 52 weeks.
6 . The method of claim 5 , wherein the subject has early-stage Parkinson's Disease.
7 . The method of claim 1 , wherein the subject is not receiving symptomatic treatment for Parkinson's disease concomitant with the antibody.
8 . The method of claim 1 , wherein the antibody is administered concomitantly with levodopa.
9 . The method of claim 1 , wherein administering the antibody is preceded by administering a loading dose of 2000 mg of the antibody and optionally uptitration at one or more subsequent dose at greater or equal to 2000 mg but less than 3500 mg until a dose of 3500 mg is reached, all doses being separated by intervals of 3-5 weeks.
10 . The method of claim 1 , further comprising monitoring the subject for a change in movement, cognitive deficit, autonomic dysfunction, gastrointestinal dysfunction, visual hallucination or a psychological symptom.
11 . The method of claim 10 , wherein the monitoring comprises
(a) providing a subject with a mobile device programmed to receive and transmit data acquired from sensors internal and/or external to the device relating to movement deficits of a subject having or suspected of having a synucleinopathy, whereafter the subject undergoes a series of movements to reveal movement deficits, if present, and the internal or external sensors of the device acquire data relating to the movements;
(b) collecting data transmitted from the mobile device; and
(c) comparing the data acquired from the subjects with control data to assess presence or extent of movement deficits in the subject.
12 . The method of claim 11 , wherein the mobile device is programmed to receive and transmit data from at least two external sensors attached to upper and lower limbs of the subject.
13 . The method of claim 11 , wherein the mobile device is carried by the subject and acquires data from an internal sensor.
Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Mar 10, 2026
From: F. HOFFMANN-LA ROCHE AG
To: HOFFMANN-LA ROCHE INC.
Reel/Frame 074023/0722 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 25, 2026
From: MOULD, DIANE
To: PROTHENA BIOSCIENCES LIMITED
Reel/Frame 073887/0107 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 25, 2026
From: SOTO, JAY; NESS, DANIEL KEITH; KOLLER, MARTIN
To: PROTHENA BIOSCIENCES INC.
Reel/Frame 073887/0158 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 25, 2026
From: PROTHENA BIOSCIENCES INC.
To: PROTHENA BIOSCIENCES LIMITED
Reel/Frame 073887/0237 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 25, 2026
From: BELLI, SARA; BOESS, FRANK; COSSON, VALERIE; GRIMM, HANS PETER; GIESCHKE, RONALD; MARTIN-FACKLAM, MERET; WEBER, SILKE
To: F. HOFFMANN-LA ROCHE AG
Reel/Frame 073887/0258 →
Continuity (3)
Provisional Application
62564992
· Sep 28, 2017
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