Levolta Pharmaceuticals Awarded U.S. Patent

Levolta Pharmaceuticals, Inc., an emerging company in developmental osteoarthritis (OA) therapy, was awarded a patent by the U.S. Patent and Trademark Office (USPTO) for its novel VOLT01, a derivative of zoledronic acid (ZA), a proposed commercial product that has shown promise as a disease-modifying drug in clinical trials. U.S. Patent 8,859,530 covers co-administration of steroids and zoledronic acid to prevent and treat osteoarthritis.

Formerly known as Voltarra Pharmaceuticals, Levolta’s patent claims methods for treating osteoarthritis by intravenously administering a combination of prednisolone, or a pharmaceutically acceptable salt thereof, and ZA, or a pharmaceutically acceptable salt thereof, in a single infusion. The patent claim does not limit the dosage of the prednisolone or the ZA. A dependent claim specifies a dosage range of between 5 mg and 50 mg of prednisolone, which encompasses all dosages that Levolta would likely consider administering.

“Receiving the patent is great news for our company, but, more importantly, the patent covers a method for providing long-term relief to osteoarthritis patients, which is desperately needed due to the ever rising number of people dealing with this illness,” said Levolta chief executive officer Richard P. Becker, Jr. “In clinical trials, not only does prednisolone minimize the incidence of side effects associated with ZA administration, it also provides long-term relief from the OA symptoms. Patients are in strong need of a disease-modifying drug for OA so this is indeed exciting news for the healthcare community as well.”

The World Health Organization estimates that osteoarthritis will be the leading cause of disability globally by 2020. In the U.S., the Centers for Disease Control and Prevention reports that osteoarthritis affects 26.9 million adults with total healthcare system costs of $21.1 billion.

“In an earlier randomized clinical trial, VOLT01 demonstrated significantly better safety and efficacy in controlling knee osteoarthritis compared to ZA alone, with the added benefit of no post dosing symptoms,” said Levolta chief medical officer Ketan Desai, M.D., Ph.D. “We have initiated a Phase III multi-center clinical trial with Menzies Research Institute in Australia to assess VOLT01 for controlling knee osteoarthritis and expect to announce results in early 2015. Creating a disease-modifying drug for osteoarthritis patients would bring vast patient quality of life benefits, not to mention the societal financial impact, and we are very encouraged by progress to date.”

The company said ZA has been shown to be effective in treating the symptoms of OA, but produces post-dose syndrome side effects, notably flushing, fever, joint pains and muscle aches. Originally marketed by Novartis as Reclast and ZOMETA, ZA is used to treat osteoporosis, Paget’s disease and bone cancers, a market that Levolta estimates was $6.2 billion in 2011. ZA, administered intravenously, had sales in excess of $1.6 billion in 2012.

Based in Bethlehem, PA, Levolta Pharmaceuticals, Inc., features a portfolio of early-stage small molecules and late-stage novel clinical compounds for rheumatology, the central nervous system, oncology and immunology, which the company obtained through the acquisitions of IMC Biotechnology and Renascense Pharmaceuticals.