Melior Discovery Inc. entered a deal to apply its indications discovery platform to Pfizer Inc. compounds, its 11th collaboration since fully beginning operations less than two years ago.
The deal with New York-based Pfizer followed by about five months a similar agreement with Merck & Co. Inc., under which Melior is applying elements of its in vivo theraTRACE platform to neuroscience compounds from Merck, of Whitehouse Station, N.J. Melior has, or has completed, deals with seven other companies, as well as two nonprofit institutions.
The theraTRACE platform entails multiplexed in vivo assays designed to discover new therapeutics indications for existing pharmaceutical compounds. The platform combines about 35 assays in a manner that allows a compound to be tested across a range of therapeutic areas. The company is using it both in partnerships and in its own discovery efforts, which have produced three compounds being prepared for clinical studies.
"We've taken an endeavor that otherwise would be impractical and made it practical by the way we've multiplexed the arrangement of these models," said Andrew Reaume, president and CEO of Exton, Pa.-based Melior. "We can do a large number of in vivo assessments on a single compound in a very short period of time, and very effectively, in a way that's really unprecedented.
"This is unique," Reaume told BioWorld Today. "The notion of multiplexing requires a good deal of know-how."
Reaume said he expects to partner with two more top-tier pharmaceutical companies in the near term, and he said the process is well under way for a significant Series B round of financing.
"There has been a tremendous proof-of-concept demonstration in a short time," Reaume said, adding that has been accomplished with limited capital. "Much to the amazement of our current investors, and to the amazement of new investors we are talking with, we have uncovered these three clinical candidates. In all cases, they are solid, rigorous clinical candidates. At the same time, they are de-risked," by having been through extensive safety, tolerability and pharmacokinetic testing.
The company's lead product, expected to enter Phase I trials this quarter, is MLR-1023, a compound that failed to show efficacy in a Phase III trial in gastric ulcers that ended around 1980. Melior's repositioning effort showed an ability of the compound to lower blood glucose levels, and it is being redeveloped for Type II diabetes.
The second compound, MLR-1045, failed to show efficacy in the early 1990s in a Phase II trial in peripheral vascular disease. Melior plans to begin trials early in 2008 in overactive bladder. The third compound, MLR-1130, has been through Phase III trials in Alzheimer's disease, but is being repositioned by Melior for treating atopic dermatitis. An investigational new drug application filing is expected early next year.
The company has filed method-of-use patent applications for all three compounds covering the new indications.
Zahed Subhan, a business development consultant at Melior, said the company discovered the new indications for those three compounds based upon the evaluation of only nine compounds. He said the company is putting another 12 of its compounds through the theraTRACE platform in the next year.
"The drug-likeness of those compounds is very important, a key criteria for us when we select those compounds" for testing in the indications discovery platform," Subhan told BioWorld Today. "They go through the 35-assay screen, and in eight weeks, out pops a new indication that we have identified in validated animal models."
The expertise on drug-like properties of compounds at Melior is provided by Christopher Lipinski, who has retired from Pfizer Inc. after supervising medicinal chemistry drug discovery efforts there about 20 years. He sits on the Melior scientific advisory board, and has an exclusive arrangement with the company in certain areas. Lipinski, considered among the most renowned scientists in the field of drug-like properties, is author of the "Rule of Five," an algorithm for predicting drug compounds likely to show oral activity. That approach has been used across the pharmaceutical industry since its publication in 1997.
Melior was founded in January 2005 and gained its seed funding the next month, a $500,000 investment that came in as part of $3.5 million in funds provided at that time to young companies in southeastern Pennsylvania. Funding was provided by BioAdvance Ventures, which uses state money that came from settlements of tobacco lawsuits to invest in the health and life sciences industries.
The theraTRACE platform was established, and the company became fully operational in June 2005. It now has about 17 employees.
Melior raised $4 million in its Series A round in January 2006. Investors were Osage Ventures, of Bala Cynwyd, Pa.; the Mid-Atlantic Angel Group, of Philadelphia; Cammeby's Capital Group, of New York; and India-based APIDC/Venture East.
Melior was founded by Reaume, who previously worked at Pfizer and Cephalon Inc., and Michael Saporito, vice president of research, who previously worked at Cephalon and Locus Pharmaceuticals Inc.
In addition to Pfizer and Merck, Melior has applied or is applying parts of its technology to discovery programs at Cephalon Inc., Marillion Pharmaceuticals Inc., Othera Pharmaceuticals Inc., Immune Control Inc., Polymedix Inc., Q-RNA Inc. and Abrika Pharmaceuticals. It also has relationships with the High Q Foundation and the Spinal Muscular Atrophy Foundation.