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Relmada Looks for a Role in the Chronic Pain Market

By Marie Powers
Staff Writer

Relmada Therapeutics Inc., which last month closed the first $3 million in a planned $5 million Series A financing, is seeking to muscle in on the chronic pain space by moving three of its candidates into Phase III studies by the middle of 2013.

The company's lead product is LevoCap, a once-daily extended-release form of the opioid levorphanol in a tamper-resistant delivery system. Unlike most other opioids, levorphanol modulates pain through both opioid and noradrenergic pathways, providing pain relief through multiple mechanisms in a single molecule.

Levorphanol also has been shown to partially reverse analgesic tolerance to morphine, potentially benefiting patients who are tolerant to the analgesic effects of other opioids.

Relmada also is working on a topical formulation of the local anesthetic mepivacaine known as MepiGel, a once-daily extended-release form of oral buprenorphine called BuTab and d-methadone, the d optical isomer of racemic methadone and an antagonist at the N-methyl-D-aspartate receptor.

The Blue Bell, Pa.-based company was founded in 2004 by Najib Babul as TheraQuest Biosciences LLC, with seed financing from BioAdvance and Ben Franklin Technology Partners of Southeastern Pennsylvania. TheraQuest raised more than $3 million and moved several programs into the clinic, receiving orphan drug designation and fast-track designation for an abuse-deterrent, once-daily, extended-release formulation of tramadol known as TQ-1017, both in HIV-associated neuropathy and postherpetic neuralgia.

The compound later was abandoned due to the proliferation of generics with similar mechanisms of action, according to Sergio Traversa, Relmada's CEO.

Then came the Great Recession. In the middle of several capital-intensive projects, TheraQuest sought to partner its lead programs with a pharma or big biotech, but those efforts came to naught, Traversa said.

A pharmacist, Traversa had worked in drug and business development both at Eli Lilly and Co. and the Johnson & Johnson division Therakos Inc. and on investment teams at ING Barings, Merlin BioMed and Rx Capital before co-founding Medeor Inc., a Cornell University pharmaceutical spinoff that was developing the d-methadone candidate. Because the drug was Medeor's only compound, prospects for attracting sufficient financing to move it to market were limited.

Through a banker specializing in biotech, Traversa was introduced to TheraQuest's Babul, and the two decided to combine their programs. TheraQuest licensed the d-methadone technology from Medeor and added it to its pipeline. Traversa joined the company, which was renamed Relmada to suggest "an army of relief," as its CEO, while Babul remained as president and chief scientific officer.

Although chronic pain is a crowded market, Relmada can use the 505(b)(2) pathway for LevoCap, MepiGel and BuTab, lowering the development risk profile, while d-methadone moves through the more traditional drug development pathway.

Buprenorphine, for example, has been widely developed for sublingual and transdermal use, with Relmada's BuTab candidate distinguished both by its oral formulation and unique pharmacology, Traversa said.

"The formulation is very complicated, but the [pharmacokinetics] data look very good," he said.

Relmada plans to complete formulation development, GMP manufacturing and pharmacokinetic studies on LevoCap, MepiGel and BuTab by early 2013 in preparation for the Phase III studies.

Medeor previously conducted an open-label Phase I/IIa safety study with d-methadone, with results supporting the compound's advancement into a Phase IIb proof-of-concept trial. The FDA is cooperating on that approach, Traversa said.

Few would dispute that chronic pain offers a world of opportunity. In neuropathic pain, the initial indication for d-methadone, products such as Cymbalta and Lyrica often make barely a dent, and opioids generally are ineffective, Traversa pointed out.

"There are a lot of options, but many patients are still not satisfied," he told BioWorld Today, predicting an effective molecule in neuropathic pain, alone, could be worth hundreds of millions in revenues.

Initial investors seem comfortable with the company's development timetable and strategy. In the financing that closed last month, BioAdvance and Ben Franklin Technology Partners as well as South Korean equity investor Wonpung Mulsan Co. Ltd. converted existing liens into Series A convertible preferred stock.

Traversa expects to complete the offering by the end of October.

Relmada has 10 employees and expects to hire several more on the R&D side over the next 12 months.

Long term, Traversa described Relmada as "a royalty company," noting the company may sell some ex-U.S. development and marketing rights, combined with licensing options, to a big biotech or pharma that can penetrate the primary care market.

However, "we definitely want to keep the rights for some of the pain specialties," he said, envisioning an effective effort in the U.S. with a sales force of approximately 120 people.

"M&A is very active in the pharma space," Traversa added. "I would like to keep an infrastructure that would provide a reason for some strategic buyer to be interested in Relmada."