Pacific Link Consulting’s work managing DMF files, as well as regulatory and clinical support culminated in Aegis being awarded the US Patent for the formula of delivery method of their Intravail® formulation.
Aegis is Awarded US Patent for Formulation and Non-invasive Delivery of Peptide Drugs
SAN DIEGO, CA August 15, 2018/NASDAQ — Aegis Therapeutics LLC announced today that it has been awarded US Patent No. 10,046,025, providing non-invasive delivery of cyclic peptide drugs. Cyclic-peptide drugs are an increasingly important chemical class of drugs that combine several favorable properties such as good binding affinity, target selectivity and low toxicity that make them an attractive modality for the development of therapeutics. More than 40 cyclic peptide drugs are currently in clinical use including antimicrobials, human hormones and drugs used to treat cancer, pain, and metabolic diseases. New powerful techniques based on rational design and in vitro evolution have enabled the de novo development of cyclic peptide ligands to targets for which nature does not offer immediate solutions.
Peptide drugs are not orally active and thus are nearly universally administered by injection. The advent of Aegis’ Intravail-based non-invasive metered nasal spray formulations provides a highly effective non-injectable alternative for greater patient convenience and acceptance.
The enabling Aegis Intravail formulation technology is broadly applicable to a wide range of peptide and non-peptide drugs to increase noninvasive bioavailability by the oral, nasal, buccal, and sublingual routes and to speed attainment of therapeutic drug levels in cases where speed is important to the patient, for example in the treatment of pain, nausea, emesis, convulsive disorders, spasticity, and the like. Aegis ProTek® excipients stabilize, prevent aggregation, and reduce polysorbate-surfactant induced immunogenicity and anaphylaxis of monoclonal antibody and peptide therapeutic formulations.
At present, more than a dozen different drugs employing Aegis Intravail® and ProTek® technologies have been reformulated for significantly improved performance by Aegis’ licensees. Our licensees include seven of the top 10 largest pharmaceutical companies and two of the top 10 largest multinational generics companies, along with many public and private biotech companies. Aegis growing patent portfolio currently has more than seventy-five issued and pending drug formulation patents covering noninvasive delivery and stabilization of biotherapeutics, biosimilars, and small-molecule drugs.
About Aegis Therapeutics
Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Our Intravail® drug delivery technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Our ProTek® excipients stabilize, prevent aggregation, and reduce unwanted immunogenicity and anaphylaxis of protein and peptide therapeutics while avoiding the oxidative damage caused by polysorbate surfactants.