LEXINGTON, Mass.—Biousian Biosystems Inc. (BBI), a biotechnology company that designs and develops drugs with potency for GPCR targets, has been awarded by the U.S. Patent and Trademark Office a long sought-after patent which describes a series of highly selective and potent delta opioid receptor agonists for the treatment of acute and chronic pain. One of the molecules covered by the patent is BBI-11008, the company’s lead drug positioned as a best-in-class analgesic.

 

Biousian applied for a patent Dec. 8, 2009, and the patent was awarded on Nov. 5, 2013, according to the U.S. Patent and Trademark Office.

 

The “Delta-opioid receptor selective analgesic” was invented by Biousian co-founders Robin Polt and Edward J. Bilsky, both listed in Lexington, Mass., according to the abstract released by the U.S. Patent and Trademark Office, which stated: “Methods and materials are provided for the production of glycosylated peptides that exhibit high affinity and specificity for delta opioid receptors. The methods and materials of the present invention may be used for treatment of conditions involving pain, such as acute pain and nociceptic pain, neuralgia and myalgia.”

An orally available drug, BBI-11008 reportedly has equivalent efficacy to opioids but exhibits markedly reduced side effects in preclinical models. Due to the unique delta opioid selectivity of BBI-11008, it reportedly lacks the toxicities usually associated with mu-selective opioid agonists (such as morphine), including respiratory distress and gastrointestinal tract immobility—and reportedly has no evidence of addictive characteristics. The molecule’s performance has been studied in extensive in-vivo preclinical pain studies, funded by multiple U.S. National Institutes of Health Small Business Innovation Research grants.

 

If it performs as advertised, people who suffer from chronic pain would get relief with BBI-11008 without worrying about becoming addicted to the powerful drug.

 

“Delta opioid receptors were first described in the 1970s, but multiple efforts to develop a highly selective agonist with drug-like properties have failed,” Ed Bilsky, a professor of biomedical sciences at the University of New England, stated in a news release. “Our novel synthetic chemistry applied to naturally occurring enkephalin opioid peptides enables us to impart small-molecule, drug-like properties to peptides.

 

“The lead molecule has therapeutic utility across a broad range of pain indications, including neuropathic pain, inflammatory pain, cancer pain and migraine,” said Bilsky.

 

The company acknowledges that the patent is good for business, and is a huge stepping stone toward gaining ground as a major player in the vast global market.

 

“The patent covers BBI-11008, and a series of backup molecules, putting the company in a strong position when discussing with pharma partners about how to develop the molecule further,” said Biousian spokesman Rob Johnson, a partner at Alacrita LLC of Cambridge, Mass.

 

Further, the patent makes BBI-11008 the exclusive property of Biousian for the duration of the patent, Johnson tells DDNews. At the same time, other companies are excluded from commercializing the technology covered in the patent, thus giving Biousian the edge.

 

Winning the patent is indeed a coup for Biousian, especially considering the competition for effective treatments in the chronic pain arena.

 

“There is tremendous unmet need for safer and more effective pain therapies,” Johnson says. “The data accumulated to date suggest that BBI-11008 is a potentially best-in-class analgesic with powerful efficacy, with none of the life-threatening or debilitating side effects of existing pain therapies.”

 

The patent “covers the composition of matter for the lead molecule, as well as a series of backup molecules, putting the company in a sound foundation for commercializing this technology,” he adds.

 

Although currently still considered a startup, Biousian is a shining example of how small companies can develop game- changing innovations to address significant unmet medical needs, Johnson maintains.

 

Alacrita is helping Biousian with business development, including securing a partnership with a pharma partner, Johnson says.

 

Mark Philip, acting president of Biousian Biosystems, stated in a news release, “We are delighted to have made such rapid progress and achieved proof of principle for both efficacy and safety for BBI-11008 in a range of preclinical models. This, together with the recently issued patent protection for this series of molecules, encourages us to accelerate the work towards moving the lead candidate into the clinic.”

 

Biousian is “actively exploring both corporate partnerships and/or equity investment to progress this molecule into clinical trials,” Philip continued.

 

Robin Polt, co-founder of Biousian and professor of chemistry and biochemistry at the University of Arizona, said, “We are very excited about the prospects for glycopeptide drugs that increase drug stability and increase penetration across the blood-brain barrier and into the central nervous system.”

 

Biousian Biosystems is a company with a stated commitment to improving the lives of patients living in chronic pain or struggling with conditions which lead to chronic pain. Using its CarboSyn technology platform, the company builds drugs that have unique selectivity and potency for G-protein coupled receptor targets.

 

Alacrita is a growing management consulting firm providing expertise-based services to the pharmaceutical, biotechnology and life science sectors. The firm is supported by a network of experts who operate across the spectrum of life sciences. Many are industry veterans with 25-plus years of experience; others are professional independent consultants operating in the life-science arena. Since its inception, Alacrita has completed successful consulting projects for big pharma, biotech companies, life-science investors, academia and government bodies, operating out of offices in London and Cambridge, Mass.