Drug resistant strains of pathogens are an urgent unmet need, but currently, despite the large market opportunity, there are no new classes of antibiotics in clinical development. In the last 60 years, there have been ten new classes of antibiotics under development, but only two in the last 40 years – and none are currently in clinical trials.

ProteLight Pharmaceuticals （长春普莱医药生物技术有限公司）of China and BioAMPs International of Denver, CO want to change that. Together, the two companies own the worldwide rights to V13K, a peptide-based antibiotic currently in pre-clinical development. Their compound is a big departure from most antibiotics, with a unique mechanism. As a peptide, V13K attacks the membrane of the pathogen, instead of targeting a metabolic pathway as a small-molecule drug would do. “Small organic molecules are completely different from V13K, which is much larger,” said Yuxin Chen, PhD, President of ProteLight in an exclusive interview with ChinaBio® Today. “We expect it will be a broad spectrum antibiotic.” In particular, they think the compound will be effective against drug-resistant bacteria, both gram negative and gram positive, that current antibiotics can’t fight.

Their story is compelling. Last month, ProteLight and BioAMPs together presented their company to 180 attendees at the ChinaBio® Investor Forum, held in Beijing on December 11 and 12, one of twenty early stage companies to do so. ProteLight and BioAMPs won the “Most Promising Company” award in the new drug category, awarded by a group of venture capitalists who are active in the China life sciences. This was the 4th forum organized by ChinaBio® and the 1st in Beijing (for more information see www.CBIF2008-BJ.com).

Chen has been working on the compound since he started his graduate studies at the University of Alberta in 2000. He did his research work in the laboratories of Dr. Robert S. Hodges, a peptide expert. Chen and his colleagues were tasked with the job of finding a practical use for a peptide, a peptide-based antibiotic that could be used in humans. It wasn’t difficult to find a powerful peptide antibiotic. In 20 to 30 years of work on peptides, many strong antibiotics had been discovered, including naturally occurring substances from frogs and moths, which were very effective. Unfortunately, they were also extremely toxic. The problem became how to tame their toxic characteristics while maintaining their useful antibiotic properties.

“Using random mutagenesis, many peptides were developed,” said Chen. “One analogue, known as V681, was supertoxic.” V681 became the template. Its hydrophobic qualities were developed, leading eventually to V13K. According to ProteLight/BioAMPs, the compound’s lipid-rich membrane is highly specific, targeting bacteria while leaving normal human cells alone. It is also very selective. The compound has a positive charge that makes it attach to bacteria and penetrate its membrane. And because of its D-conformation, it is resistant to proteases, giving V13K a much longer half-life than the L-conformation peptides.

The entire discovery process took about five years – a long period, but a short development time for a new drug class. “The design work was done first, and it was a good design, so we didn’t waste any time,” explained Chen.

In 2004, Dr. Chen and the entire peptide lab went with their mentor, Dr. Hodges, to the University of Colorado at Denver and Health Sciences Center. When Chen graduated in 2005, he knew he wanted to start a company in China, and he purchased the China rights to V13K, forming ProteLight. The name derives from joining the words protein – after all, a peptide is a shorter protein – and light, which connotes a sense of hope and promise.

The ex-China rights to the technology were licensed to BioAMPs, which is following ProteLight along the development path. BioAMPs is a sister to Sharklets, a company that is working on developing a material that mimics the scales of shark skin and seems to be a natural deterrent to pathogens.

“ProteLight and BioAMPs will share knowledge and are co-developing the compound,” says Chen. “We will take advantage of the low costs of China and its shorter development time, using China as a base, especially for our pre-clinical studies. The results will be sent back to the US to save time and money.” Each of the China experiments must be repeated in the US. At the moment, the US FDA will not accept results from China-conducted animal tests or human trials.

For now, the two companies are legally distinct, though that will change in the future. “Although we are currently two separate entities, we each have the leader from the original discovery group as part of our organizations – Dr. Bob Hodges,” said David A. DeLong, CEO of BioAMPs. “Together we control global rights to the technology.”

The plan is to eventually merge the two entities into one, though there is a structural reason to leave them distinct for the moment. “Both companies are in the middle of capital raises, and they are also raising grant money, which must be spent ‘on shore,’ not in a foreign country,” commented DeLong. “Once the two companies get to the next step, which is to raise institutional money, the two entities must be combined.”

To progress this far, ProteLight has raised money from private investors in China, and it has also received local government support.

Presently, ProteLight together with BioAMPs is seeking to raise $5.2 million. That money will take V13K through its Phase I proof of concept trial in China and the filing of an IND in the US. ProteLight estimates the phase of the development process will take about 26 months

When the time comes, ProteLight is open to various exits. Chen is well aware that big pharma may find V13K a very attractive proposition. “We are flexible on that point,” he said. We can take V13K through Phase I, its proof of concept, and sell the product to big pharma. If the market is not good and if we have funds, we could take it all the way to approval.”

If V13K proves to be effective against drug-resistant strains of pathogens, ProteLight and BioAMPs will be able to write their own ticket.

Disclosure: none. .