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GLP-1 production. Lactitol and other similar sugars can cause side effects including diarrhea, abdominal pain, and gas, though. So Szewczyk settled on using glutamine for BKR-013 and looked to license the technology to someone who could develop it, then test it. He found no takers.
Szewczyk and Nolan, meanwhile, were introduced by a mutual friend. Nolan, who has preclinical and clinical-trial experience from contract research organizations, joined with Szewczyk to form BioKier. And Gribble, whose research inspired Szewczyk to explore glutamine’s role in GLP-1 production, has since become a BioKier collaborator and now sits on the company’s scientific advisory board.
With successful animal tests under its belt, BioKier is now trying to show its approach can work in humans. The Mayo Clinic in Rochester, MN, is currently enrolling type 2 diabetes patients in a Phase 1 study evaluating a suppository form of BKR-013. In the meantime, the company is working on making a once-daily pill form of the drug, using a coating technology that it has licensed exclusively from the University College London School of Pharmacy. That coating, along with the pill’s formulation, Szewczyk explains, will allow the tablet to travel undigested until it reaches the colon, where it will release the glutamine.
BioKier, which had received seed funding from angel investors as well as a research loan from the NC Biotechnology Center, last year raised $1.7 million from Broadview Ventures and the American Heart Association. The money is expected to take the startup through the Phase 1 study and pill formulation, after which it would need between $6 million and $10 million for Phase 2 trials. Tests could also be done comparing BKR-013 against other GLP-1 drugs. But Szewczyk says the scale of these tests are beyond the capacity of a tiny company like BioKier, whose only full-time employees are himself and Nolan.
Indeed, the startup is already talking to potential pharma partners (Szewczyk declines to say which ones), pitching BKR-013 as potentially faster and less expensive to take through the regulatory process compared to a completely new compound. Glutamine is already used in other FDA-approved drugs, and so has already been vetted for safety and toxicity. Szewczyk says the company should therefore only need to demonstrate BKR-013’s efficacy in diabetes. If the FDA signs off on BioKier taking this so-called 505(b)(2) regulatory pathway, the company or a pharma partner might not need to test BKR-013 in lengthy and expensive Phase 3 clinical trials. Szewczyk says the company is talking with the FDA to see if the agency will accept that approach and if so, what specific data it would require.
There’s a disadvantage of using an already vetted active ingredient, though—since glutamine is not a new molecule it doesn’t come with 20 years of patent protection. Szewczyk concedes that this could dissuade some pharmas from bringing BKR-013 into their drug portfolios. But he notes that BioKier does hold two patents protecting BKR-013’s method of delivering a drug formulated to release in the colon and the use of glutamine and another compound, butyrate, in treating type 2 diabetes and other metabolic diseases. Additional patents are pending.
Szewczyk says venture capitalists tell him they won’t invest in BioKier unless the company can show BKR-013 can be made in a pill form. Potential pharma partners, on the other hand, are primarily concerned with seeing clinical trial results in humans. So BioKier is pressing forward on both fronts. Szewczyk says the pill form of the drug should be ready by the end of the year. By then, the company could also have Phase 1 clinical trial results.
“We hope that the data we get will be sufficient to get enough interest to secure financing for the Phase 2 study, but we’ll see,” Szewczyk says.