Four months ago San Diego-based Elevation Pharmaceuticals unveiled a $30 million venture round as it mapped out plans to complete an ambitious mid-stage program for its COPD treatment. Today the biotech boasted that the therapy--EP-101--had registered positive data in a Phase IIb study, positioning it as a potential new "gold standard" in nebulized treatments for the ailment.
Investigators report that their formulation of glycopyrrolate--a long-acting muscarinic antagonist, or LAMA, delivered by an experimental nebulizer device licensed from PARI Pharma--delivered the desired bronchodilation in a matter of minutes. Elevation compared the drug's effects with a placebo arm.
"These positive results from our first multi-dose trial of EP-101 are very encouraging and supportive of our mission to significantly improve the standard of care for patients with severe COPD," said Elevation CEO Bill Gerhart. "Pulmonologists are enthusiastic about the potential availability of a nebulized once-daily LAMA, and patients love the significant improvement in convenience offered by our new handheld delivery device." Another IIb study will be mounted to determine the precise dose the biotech will test in a late-stage study.
COPD is a bustling field in biopharma R&D. Novartis ($NVS) has high hopes for QVA149, its combination of indicaterol and NVA237. GlaxoSmithKline ($GSK) and Theravance ($THRX) are pushing ahead with their application for Relovair. Forest ($FRX) enjoyed an upbeat FDA panel review for its contender, aclidinium (licensed from Almirall), back in February. And Pearl Therapeutics has its own promising mid-stage program.
None of the competition, though, has deterred Elevation's venture backers. Novo Ventures led the latest round for the developer, with Canaan Partners, TPG Biotech, Care Capital and Mesa Verde Venture Partners all chipping in as well.
- here's the press release