# US 2017/0283464 A1 · Crystalline And Amorphous Forms Of A Beta-Arrestin Effector

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- Number: US 2017/0283464 A1
- Document ID: US20170283464A1
- Status: Published application
- Kind: A1
- Application number: 15/345,234
- Filed: 2016-11-07
- Published: 2017-10-05
- Earliest claimed: 2014-02-07
- Assignees: Trevena, Inc.
- Applicants: Trevena, Inc.
- Inventors: Ritesh Sanghvi; Gregory Alcorn; Graham Richard Lawton; Meiki Yu; Matthew Ronsheim; Jiaher Tian; Shao Hong Zhou; Yuriy B. Kalyan
- Web page: https://patentgrep.com/patent/US20170283464A1

## CPC

- C07K 7/64: Cyclic peptides containing only normal peptide links
- A61K 38/12: Cyclic peptides {, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C (A61K38/043 - A61K38/046 take precedence)}
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 9/04: Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
- A61P 9/12: Antihypertensives
- A61P 13/12: of the kidneys
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C07K 7/06: having 5 to 11 amino acids
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present disclosure provides novel crystalline forms of a compound that acts as a β-arrestin effector, processes for preparing novel crystalline and amorphous forms of a compound that acts as a β-arrestin effector and uses thereof.

## Claims

### Claim at position 1

1-42. (canceled)

### Claim 43

A process for preparing a crystalline form of a peptide having a sequence of SEQ. ID. NO.1, comprising crystallizing SEQ. ID. NO. 1 to form a crystalline form of a peptide having a sequence of SEQ. ID. NO. 1.

### Claim 44 (depends on 43)

The process of claim 43, wherein the crystallizing comprises dissolving peptide in an aqueous solution and crystallizing the peptide to form the crystalline form therefrom.

### Claim 45 (depends on 44)

The process of claim 44, wherein the aqueous solution is deionized water.

### Claim 46 (depends on 44)

The process of claim 44, wherein the aqueous solution consists of deionized water.

### Claim 47 (depends on 44)

The process of claim 44, wherein the process further comprises precipitating the peptide after dissolving the peptide in the aqueous solution.

### Claim 48 (depends on 47)

The process of claim 47, wherein the precipitating comprises heating the aqueous solution and cooling the aqueous solution to ambient temperature to precipitate the peptide in the crystalline form.

### Claim 49 (depends on 48)

The process of claim 48, wherein the process further comprises cooling the aqueous solution to a temperature of about 0 to about 5° C. to precipitate the peptide in the crystalline form.

### Claim 50 (depends on 43)

The process of claim 43, further comprising lyophilizing the crystalline form.

### Claim 51

A pharmaceutical composition comprising a crystalline form of a peptide having a sequence of SEQ. ID. NO.1.

### Claim 52 (depends on 51)

A method of treating a cardiovascular or a cardiorenal disorder comprising administering to a patient in need thereof the pharmaceutical composition of claim 51.

### Claim 53

A crystalline form of a peptide having a sequence of SEQ. ID. NO. 1.

### Claim 54 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising a peak at about 18.5±0.5 degrees 2θ.

### Claim 55 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising a peak at about 10.1±0.5 degrees 2θ.

### Claim 56 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising a peak at about 8.2±0.5 degrees 2θ.

### Claim 57 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising a peak at about 20.2±0.5 degrees 2θ.

### Claim 58 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising a peak at about 24.4±0.5 degrees 2θ.

### Claim 59 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising peaks at about 18.5, and at about 10.1±0.5 degrees 2θ.

### Claim 60 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising peaks at about 10.1, and at about 8.2±0.5 degrees 2θ.

### Claim 61 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising peaks at about 8.2, and at about 20.2±0.5 degrees 2θ.

### Claim 62 (depends on 53)

The crystalline form of claim 53, characterized by an X-ray powder diffraction pattern comprising peaks at about 20.2, and at about 10.1±0.5 degrees 2θ.