San Diego, CA, June 28, 2017 – Aegis Therapeutics announces positive Phase 2 results of DFN-02 using Intravail® technology. Dr. Reddy’s Laboratories in collaboration with Promius Pharma, LLC (a wholly owned subsidiary of DRL) is developing DFN-02, a novel intranasal migraine treatment using Intravail for the acute treatment of adults with migraine with or without aura. Promius Pharma will market the drug product once approved.
In this multicenter, double-blind study (Clinicaltrials.gov # NCT02856802), episodic migraine patients were randomized to receive either DFN-02 or placebo to treat a migraine attack with a moderate or severe pain level. The primary endpoint was the proportion of subjects with migraine pain freedom at 2 hours postdose (2hPF).
A significantly higher proportion of subjects experienced 2-hour Pain Freedom with DFN-02 compared with placebo: 43.8% (n=48) versus 22.5% (n=40), P<0.05. DFN‑02 was also significantly better than placebo at alleviating patient-identified most bothersome symptom (MBS), from among nausea, photophobia, and phonophobia (70.7% versus 39.5% MBS free at 2 hours postdose; P<0.01). DFN-02 was well tolerated, with only 5 of 50 subjects reporting a mild or moderate adverse event.
According to Dr. Edward Maggio, Chief Executive Officer of Aegis Therapeutics, “We are very pleased to work with Dr. Reddy’s laboratories, a leading multinational pharmaceutical company, to develop this product for people with migraine”.
According to Mr. Ralph Barry, Chief Business Officer of Aegis Therapeutics, “At present, more than a dozen other drugs employing Aegis Intravail® and ProTek® technologies have been reformulated for significantly improved performance by Aegis’ licensees, which include seven of the top 10 world’s largest pharmaceutical companies and two of the top 10 leading multinational generics companies, along with a host of public and private biotechnology companies.”
DFN-02 is a novel intranasal spray formulation composed of sumatriptan 10 mg and Aegis Therapeutics’ Intravail® permeation-enhancing excipient. This formulation of DFN-02 allows sumatriptan to be rapidly absorbed into the systemic circulation, and it exhibits pharmacokinetics comparable to subcutaneously administered sumatriptan. DFN-02 is being developed for the acute treatment of migraine with or without aura.
About Promius Pharma LLC
Promius Pharma is a wholly owned subsidiary of Dr. Reddy’s Laboratories, one of the largest and most respected pharmaceutical companies in the world. With a robust commercial infrastructure and extensive research and development capabilities through its parent company, Promius Pharma is committed to bringing new products to market that meet patients’ needs in dermatology and neurology. For more information, visit www.promiuspharma.com.
About Aegis Therapeutics LLC Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Its 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. Its 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 currently found in most protein injectable drugs. For more information, please visit www.aegisthera.com.
Intravail® and ProTek® are registered trademarks of Aegis Therapeutics LLC.