An Israeli drugmaker has come out of stealth and enrolled the first patient in its Phase III study that aims to treat an eye disorder using a drug derived from a type of tree resin.
Regenera Pharma announced Thursday the enrollment of the first patient in the 234-patient study of RPh201 in nonarteritic anterior ischemic optic neuropathy, or NAION, which is a type of stroke of the optic nerve. The drug is a patented extract of gum mastic – long used in traditional medicine and in nutraceuticals, as well as flavoring in the Greek liqueur mastiha – that has been purified, formulated and stabilized through a proprietary process. The randomized, placebo-controlled study is expected to enroll patients over six months at a dozen sites in the US, CEO Jordan Rubinson said in a phone interview. The study’s ClinicalTrials.gov page currently lists three sites, in Connecticut and South Carolina.
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The Ness-Ziona, Israel-based company is also running a Phase IIa study of the drug in Alzheimer’s disease patients, which is taking place at five sites in Canada. That study is expected to enroll 45 patients by the end of next month, after which the company will decide whether to enroll the full 81 patients as long as the drug is able to reduce cognitive decline, Rubinson said. He added that preclinical studies on rats have shown the drug can reduce losses in short- and long-term memory.
The rationale for the Phase III NAION study is data from a randomized Phase II study that, while not powered to show statistical significance, indicated that 36 percent of patients on RPh201 saw an improvement in vision of three lines or more, compared with 12 percent in the placebo group. The Phase III study has statistical power to be positive if at least 20 percent of patients on the drug respond, with the assumption that only 5 percent of those on placebo will respond, Rubinson said.
The company is funding its studies using money from a $20 million Series B round it raised from Israeli venture capital firm aMoon last year. The company is conservative about spending, so the money should be sufficient for the trials, Rubinson said. The round’s first $10 million has already been paid out, and Ra’anana-based aMoon – paying through its aMoon I fund – has provided guarantees of another $10 million for 2019, he said. The venture capital firm and a publicly traded Israeli company, InterCure – based near Haifa – each contributed half of the last round, which totaled about $5-6 million, he said.
In addition to aMoon, Regenera is looking to raise money on top of the remaining $10 million from the Series B, in particular with participation from US-based venture capital funds, Rubinson said, adding that aMoon is keen on the company adding additional investors. Such additional funding could be an add-on to the Series B or, if large enough, incorporated into a Series C round, the latter of which would be the last private funding before an initial public offering, he said.
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