American-Israeli startup PhaseV is on a mission to overcome one of the most significant challenges of drug development: the clinical trial phase, the longest and most expensive part of the process.
A recent Deloitte report reveals that, on average, a single new drug takes $2.3 billion and seven years to develop.
Yet many candidates fail the clinical phase even if the biology works. That makes for a poor return on investment and wasted potential for treating diseases.
“The development process for new drugs must therefore be transformed and could be made much more efficient with digital technologies,” the report urges.
Raviv Pryluk, CEO and cofounder, PhaseV. Photo courtesy of PhaseV
Raviv Pryluk and Elad Berkman founded PhaseV in January to do just that, combining their experience in designing, executing and analyzing experiments with the latest AI and machine-learning capabilities.
“We want to improve the world by helping to bring new medications and treatments to patients who need them,” says Pryluk.
“We try to make experiments more dynamic, to leverage every accumulated datapoint efficiently and effectively, adapting and optimizing the experiment along the way,” he explains.
“When the trial ends, our retrospective analysis extracts maximum value from the data using machine learning.”
This approach has already reaped rewards for clients, Pryluk says.
In trials where the drug didn’t work on the entire population tested, PhaseV technology has identified subgroups in whom it does work.
And in trials where the drug worked marginally on the entire population, PhaseV identified subgroups in whom the effect was significant.
Dr. Miriam Kidron, CSO at Israeli-founded Oramed Pharmaceuticals — which is developing an oral insulin capsule – says that PhaseV’s retrospective analysis of its Phase 3 trial in the United States “found subpopulations of patients that responded very well to oral insulin for the treatment of type 2 diabetes.”
These successes were key to PhaseV’s successful $15 million funding round led by Viola Ventures and Exor Ventures, including participation from LionBird and angel investors.
Elad Berkman, CTO and cofounder, PhaseV. Photo courtesy of PhaseV
The funding round was completed just after Israel was drawn into a deadly war with Hamas in Gaza. Pryluk and Berkman weren’t sure if announcing their good news was appropriate at such a time.
Ultimately, they decided it was important to spread some light in the face of the darkness, as Pryluk puts it.
“On October 7, Israel faced an unprecedented terror attack and encountered a level of brutality unlike anything witnessed before. We debated a lot whether to go out with this announcement, but we decided that we will not let terror win,” said Pryluk.
Speaking to ISRAEL21c from the BIOEurope conference in Munich in early November, Pryluk added that the “V” in the company’s name not only stands for the number five but also for “victory.”
“It’s not easy to be here in Munich conducting business as usual. It’s obvious that things are not usual. But we have to continue for those who are fighting diseases. As hard as it is, we have to do it.”
There was more good news in November: PhaseV signed a partnership with Tel Aviv-based biopharma marketplace 9xchange.
“The 9xchange platform helps ‘liberate’ drugs from owners who are unlikely to pursue them further, while providing access to the right technologies to unlock the potential of such assets and support the optimal trial to ensure their success,” says Pryluk.
Under the agreement, 9xchange members — pharma, biotech, investors, entrepreneurs and academic centers — can access Phase V’s AI and machine-learning technologies to optimally design, execute and retrospectively analyze advanced clinical studies on drug candidates that otherwise wouldn’t get developed.
“Too many deserving drugs never get to patients due to insufficient resources or attention, or objective issues such as suboptimal trial design,” said 9xchange CEO and cofounder Anat Naschitz.
“For our members, the PhaseV partnership means new opportunities. Owners can chart a new course for assets lost to trial failure, increase the value at sale and build confidence in a likely outcome. Buyers and investors can conduct due diligence on an asset and circumscribe the cost and probability of success,” she said.
This partnership, Pryluk adds, could change the course of development and enable more mergers and acquisitions, which are at the core of pharma industry.
“The big names want to acquire assets and push them forward through their clinical development, manufacturing and marketing teams. Biotechs are trying to push novel biology to the market through pharma companies.”
Headquartered in Boston, with its R&D center in Tel Aviv, the 20-employee startup is working in therapeutic areas including oncology, endocrinology, autoimmune diseases and rare diseases.
In addition to experts in machine learning, data science and software, the company recruited a scientific advisory board of drug-development experts from giants such as Pfizer, Roche and Novo Nordisk to help them define restrictions and opportunities in the highly regulated pharma industry.
Biomedical research veteran Dan Goldstaub, who previously managed clinical trials at Teva and MSD, joined the company as a scientific cofounder.
“We believe the synergy between modern technology and well-established drug-development techniques is what will bring the change,” Pryluk says.
Like most Israeli businesses, PhaseV is feeling the effects of the war.
“On one hand, we have employees fighting in the reserves. On the other hand, we understand that what we are doing is really important for the economy of Israel and more broadly for the betterment of the world,” says Pryluk.
“We don’t want what happened to stop us from progressing.”
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Produced in association with ISRAEL21c
