Here’s a compelling thought: All the HIV drugs currently on the market work by suppressing some form of the virus and its ability to replicate itself. What if you created a drug that did the opposite–one that uses the replication process to get the virus to mutate more often, something that makes the HIV virus eventually weaken and collapse?
Scientists at Koronis Pharmaceuticals, a small private biotech company in Seattle, have a drug candidate that does just that. It’s been tested in 80 people who have HIV and for whom existing drugs were no longer effective. Results from the Phase 2-A trial, released in January, showed that Koronis’ experimental drug does increase the frequency of mutations in the HIV genome.
More trials have to be done to determine if the Koronis drug can essentially take down the HIV virus, but at least one analyst believes it could be a game changer. Katherine Xu, a biotech analyst for William Blair, said in a report earlier this year that the Koronis drug has “huge potential for disruption.” One scenario she paints: that the Koronis drug be given in combination with an existing drug like Atripla and “after a year or so, the viruses could be mutated out of existence and the patients could achieve a cure,” Xu wrote in a report for Wedbush Securities, where she worked until recently. “If it were to be successful, it would be great news for the field,” Xu told me last week in a phone interview.
Scientists at Koronis have been able to eradicate HIV in a petri dish. Doing so in humans is likely to be much more difficult, but worth a try. Traditional HIV drugs attempt to block viral replication. Koronis CEO Donald Elmer explains that the Koronis drug uses the viral replication process to induce additional mutations in the HIV genome by mismatch base pairing. “These additional mutations progressively debilitate the virus, which ultimately results in collapse of the viral population,” he says.
This month marks 30 years since the virus now called HIV made its first horrific emergence among gay men. Incredible progress has been made in the decades since, but almost all of that is evidenced in the U.S. and Europe. Of the 33 million people living with HIV, 25 million are not currently being treated; 90% of the $14 billion a year spent on treating HIV is focused in North America and Europe.
“Outside the U.S., HIV is still a pandemic,” says Koronis CEO Elmer, who says that treating HIV is complicated and requires regular monitoring –something that just isn’t happening in poor countries. Thus the urgent need for a new kind of treatment. A lurking concern –and another reason to pursue new kinds of drugs — is the rise of drug-resistant HIV.
The next step for Koronis is to come up with $15 million to $20 million to perform a clinical trial that would combine its drug candidate with an approved drug that is currently used for HIV treatment. The company has raised $43 million since it was founded in 2002 but is in need of outside cash. It’s in discussions with the six big companies that operate in the HIV sector – Gilead (GILD), Bristol-Myers Squibb (BMY), Abbott Laboratories (ABT), Viiv (which is a joint venture between Pfizer and GlaxoSmithKline), Johnson & Johnson and Merck – but is pursuing other avenues as well –including a possible partnership with a non-U.S. company. It’s open to investment from deep-pocketed individuals who want to help further HIV drug development.
Finding a cure for HIV has been a holy grail for scientists in the field. It’s way too early to say for sure that the Koronis drug is the route to that cure. But until it undergoes further tests, it’s too early to rule it out as well.
Kerry A. Dolan