IP Library Granted Patent US 10,034,863
Granted Patent B2
US 10,034,863 · App. 15/291,173 · Granted Jul 31, 2018

Compositions for an orally active 1,2,4-oxadiazole for the treatment of disease

Inventors: Samit Hirawat (Chatham, NJ); Langdon Miller (Seattle, WA)
Assignee: PTC Therapeutics, Inc.
A61K31/4245A61K9/0053A61K9/145
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Quick Facts
Patent No.
US 10,034,863
App. No.
15/291,173
Granted
Jul 31, 2018
Kind
B2
Abstract

The present invention relates to specific doses of and dosing regimens for using a 1,2,4-oxadiazole benzoic acid compound in treating or preventing diseases associated with nonsense mutations. In particular, the invention relates to specific doses and dosing regimens for the use of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazol-3-yl]-benzoic acid in mammals having diseases associated with nonsense mutations.

Claims (8)

1. A unit dosage formulation comprising 25.0% by weight of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazol-3-yl]-benzoic acid or a pharmaceutically acceptable salt thereof, 25.7% by weight of refined polydextrose, 25.0% by weight of mannitol, 12.8% by weight of polyethylene glycol 3350, 3.7% by weight of poloxamer 407 powder, 5.0% by weight of crospovidone, and less than 2% by weight of one or more excipients selected from hydroxyethyl cellulose, vanilla flavor, non-bovine magnesium stearate or colloidal silica.

2. The unit dosage formulation of claim 1 , comprising 125 mg to 1000 mg of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazol-3-yl]-benzoic acid or a pharmaceutically acceptable salt thereof.

3. The unit dosage formulation of claim 1 , comprising 250 mg to 1000 mg of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazol-3-yl]-benzoic acid or a pharmaceutically acceptable salt thereof.

4. The unit dosage formulation of claim 1 , comprising 125 mg, 140 mg, 175 mg, 200 mg, 250 mg, 280 mg, 350 mg, 500 mg, 560 mg, 700 mg, 750 mg, or 1000 mg of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazol-3-yl]-benzoic acid or a pharmaceutically acceptable salt thereof.

5. The unit dosage formulation of claim 1 , wherein the unit dosage formulation is packaged in plastic bottles.

6. The unit dosage formulation of claim 1 , wherein the unit dosage formulation is a powder or granules packaged in a sachet.

7. A suspension comprising the unit dosage formulation of claim 1 , wherein the suspension has a concentration of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazol-3-yl]-benzoic acid or a pharmaceutically acceptable salt thereof selected from 25 mg/mL or 50 mg/mL.

8. The suspension of claim 7 , wherein the suspension is in water, milk, a carbonated beverage, juice, apple sauce, baby food or baby formula.

Assignments (6)
TERMINATION AND RELEASE OF PATENT SECURITY AGREEMENT @ REEL 061803 AND FRAME 0878 Recorded Oct 20, 2023
From: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
To: PTC THERAPEUTICS, INC.
Reel/Frame 065303/0163 →
SECURITY INTEREST Recorded Oct 28, 2022
From: PTC THERAPEUTICS, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 061803/0878 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2022
From: HIRAWAT, SAMIT; MILLER, LANGDON
To: PTC THERAPEUTICS, INC.
Reel/Frame 058992/0658 →
RELEASE OF SECURITY INTEREST Recorded Jul 14, 2020
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PTC THERAPEUTICS, INC.
Reel/Frame 053209/0872 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCLUSION OF 6420591,6583309,6503713, 5843995,7029846,7056656, 6468969,6486305,6630294, 6989256,6627398,8247167, 9017935 PREVIOUSLY RECORDED ON REEL 042418 FRAME 0774. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Aug 24, 2017
From: PTC THERAPEUTICS, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 043672/0096 →
SECURITY INTEREST Recorded May 8, 2017
From: PTC THERAPEUTICS, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 042418/0774 →
Continuity (5)
Division 14221352 · Mar 21, 2014
Continuation 11918114
Provisional Application 60787395 · Mar 30, 2006
Provisional Application 60669789 · Apr 8, 2005
Related Publication 20170027913A1 · Feb 2, 2017