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Shooting from the HIP
WYNNEWOOD, Pa.—Confident that it has a groundbreaking and effective way to treat and perhaps even cure diabetes, CureDM Inc. recently published preclinical findings in the journal Endocrine Practice showing that the company's novel peptide may actually lead to a method of recreating entire insulin-producing islets in the pancreas.
"A lot of people are pretty focused on replacing or regenerating beta cells in the pancreas, but that is just one of four cell types found in the islets," points out Loraine V. Upham, chief operating officer of CureDM. "What we need for people with diabetes is restoration of glucose control, and beta cells alone don't do that. You need other hormones besides insulin. Restoring insulin production or giving someone insulin doesn't control glucose really—it mostly just keeps them from dying because the insulin is what they most desperately need."
What CureDM has been focused on for the past couple years—after discovering a promising metabolic pathway and a 174-amino-acid protein—was to pare down the protein they found into a more affordable and stable 14-amino acid human peptide called Human proIslet Peptide (HIP). HIP consists of the bioactive region in the human REG3a gene responsible for regenerating pancreatic islets, a process also known as islet neogenesis.
"Utilizing an innovative and proprietary approach to evaluate the human genome and proteome from a physiologic perspective, we were able to identify a highly conserved bioactive gene product that triggers islet neogenesis," says Dr. Claresa S. Levetan, chief medical officer and a founder of CureDM. "Restoring functional islets as a therapeutic approach is fundamental to curing the underlying disease."
Equally fundamental, though, is getting money to finance the work. Thus far, CureDM has raised some $3 million and, in addition to promising preclinical work, has been able to fund the creation of enough GMP material to carry the company through Phase IIa proof of concept clinical trials when it has money—or a partnership—to get that far.
"We've already started the q-TOX work, and if we have the funding in place, we could be finished with toxicology within six months," says Dr. H. Joseph Reiser, CEO of CureDM. Phase I through Phase IIa work could be finished up within two year with some additional funding, he notes, but at that point, a merger or a partnership with a significantly bigger company would likely be needed to ensure enough resources for larger dosing studies going forward.
The company has a number of private investors, Reiser notes, many of whom live with diabetes themselves. He also has faith that some venture capital funding might materialize to bolster the angel investors currently on board.
"Often, the VC funders want to see a product already in the clinic, but because we have such a unique technology and approach, we've gotten some interest from that quarter already," Reiser says.
Convincing larger companies to perhaps enter into a partnership with CureDM is a challenge, Upham notes, but not insurmountable. One problem, though, is in potentially convincing companies that already have a stake in traditional diabetes treatments that it's worth their while to pursue a potentially curative path that would cut into their sales of insulin or other such products.
In the meantime, Reiser and the rest of CureDM have been working on other creative ways to fund their work. For one thing, Reiser notes, the company is committed to remaining a virtual one for quite some time, keeping a cap of no more than probably five people with "core know-how whether on the preclinical or clinical side."
In addition, CureDM has developed a network of CROs, production and formulation experts, legal and professional firms and others to provide services in a sort of "in kind" fashion.
"We've spent a lot of the past two months putting together contractual relationships in which can get the services of these experts in critical and leveraged way at reduced cost, with the differential for them being manifested in equity offerings from our company," Reiser explains. "We recently singed an agreement with a well-known CRO, Calvert Laboratories, to continue our tox program all the way to Phase IIa. That impact of just that single relationship is worth potentially several millions of dollars to us."