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Publication Number
US-12606609-B2
Publication Date
2026-04-21
Expiration Date
Abstract
The present invention is directed to polypeptides having the properties of both SP-C and SP-B surfactant proteins and to the corresponding reconstituted surfactants. The invention is also directed to the pharmaceutical compositions thereof and to their use for the treatment or prophylaxis of neonatal respiratory distress syndrome (RDS) or other respiratory disorders such as acute RDS.
Core Innovation
The invention relates to “combo peptides,” which are polypeptides defined by a general formula (I) (SEQ ID NO: 7). The polypeptides are designed to combine properties of surfactant protein SP-C and SP-B within a single chain, and specific peptide structural variants are described by formulas (I), (II)–(IV), and shorter variants including III, IIIe, IIIf, IIIg, IIIh, and others.
The general formula constrains amino-acid residues through residue-group selections, including defined sets for Ω, Φ, X, B, and Z, and structural variables p and q each independently 0 or 1, n an integer between 1 and 8, and r 0 or 1. The description links these constrained designs to alpha-helix formation by preferred residues within the peptide sequences.
The combo peptides are used to form reconstituted surfactants comprising a lipid carrier and the peptide. The documented use case is neonatal RDS and acute respiratory disorders, including a rabbit neonatal RDS model without external PEEP, and the description states that peptide-containing surfactants improve lung compliance and lung gas volume compared with phospholipid-only controls.
Claims Coverage
The independent claim covers a polypeptide represented by the general formula (I) (SEQ ID NO: 7) with multiple position-specific amino-acid constraints, parameterized by binary variables p and q, an integer n between 1 and 8, and r. Dependent claims refine this coverage by specifying concrete formula variants and narrowing allowed residue sets and parameter values, and the family further extends to reconstituted surfactants and pharmaceutical compositions with explicit lipid and concentration constraints.
Polypeptide defined by general formula (I)
A polypeptide represented by general formula (I) (SEQ ID NO: 7), where Ω, Φ, X, B, and Z residues are selected from specified amino-acid sets, p and q each independently equal to 0 or 1, n is an integer between 1 and 8, and r is 0 or 1.
Selected combo peptides as SEQ ID NOs 1 through 5
The polypeptide is selected from a group of five specified polypeptide sequences identified by SEQ ID NOs 1 through 5.
Parameter setting p=1
The polypeptide of the general formula is defined with p set to 1.
X position restricted to I or L
Each position X in the polypeptide is independently equal to I or L.
Reconstituted surfactant lipid mixture with DPPC and palmitoyl oleoyl phospholipids
A reconstituted surfactant whose phospholipid mixture includes DPPC and a palmitoyl oleoyl phospholipid that is either POPG or a POPG/POPC mixture in a by-weight ratio range from 95:5 to 20:80.
Pharmaceutical composition with reconstituted surfactant at defined concentration
A pharmaceutical composition includes the reconstituted surfactant at a concentration between 2 mg/ml and 160 mg/ml.
Overall, the claim set centers on a polypeptide defined by general formula (I) (SEQ ID NO: 7) with specific residue constraints and binary/integer parameters, and then covers particular allowable polypeptide sequences and parameter refinements. The dependent coverage extends to reconstituted surfactants with specified DPPC and palmitoyl oleoyl phospholipid mixtures and to pharmaceutical compositions containing the reconstituted surfactant within a defined concentration range.
Stated Advantages
Improves lung compliance and lung gas volume in a rabbit neonatal RDS model without external PEEP.
Stabilizes an alveolar phospholipid film similarly to SP-B/SP-C analog-containing surfactants.
Provides improved simplicity and cost-efficiency.
Shows activity at low peptide doses (0.1–3% w/w).
Documented Applications
Use in connection with neonatal respiratory distress syndrome (RDS) and acute respiratory disorders, including prophylaxis and treatment with a reconstituted surfactant for administration.
Evaluation in a rabbit neonatal RDS model without external PEEP using readouts including tidal volume/compliance and lung gas volume.
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