Belite Bio wants public investors to bankroll late-phase clinical trials of a treatment for certain causes of blindness. With one study underway and another on the horizon, the San Diego-based biotech has filed the paperwork for a Nasdaq IPO.
Around two-thirds of the anticipated IPO haul is earmarked for clinical trials of LBS-008, a RBP4 inhibitor Belite thinks can reduce the accumulation of toxic byproducts of vitamin A in the eye. Belite plans to spend a soupçon of the money on a phase 3 clinical trial that is already underway in Stargardt disease, a form of juvenile macular degeneration, with most of the rest funding phase 2/3 work in dry age-related macular degeneration (AMD). A phase 2 or 3 study in dry AMD is scheduled to start this year.
The late-phase programs are underpinned by data from completed phase 1 and phase 1b trials in healthy volunteers and Stargardt patients. Belite tracked a 70% reduction in RBP4 relative to baseline in Stargardt patients, offering encouragement that the drug hits its target, and saw no serious treatment-emergent adverse events or deaths. As expected, transient night vision impairment cases occurred but were mild.
Stargardt and dry AMD both represent unmet medical needs, but Belite is far from the only company that is trying to address the needs. In its IPO paperwork, Belite identifies four companies, three in the U.S. and one in Japan, with treatments for Stargardt in phase 2 to 3 clinical trials, plus three companies that are in late-phase development in geographic atrophy, an advanced form of dry AMD.
Other companies are in pursuit. Stargardt has emerged as a proving ground for ways to overcome the AAV capacity limit that restricts the diseases that are amenable to treatment with gene therapies. This year alone, SalioGen Therapeutics and SpliceBio have raised money to fund pipelines that feature assets against Stargardt.
While Belite still needs to convince public investors that it can carve out a space in the market, it has already secured insider support for the IPO, with its principal shareholder Lin Bioscience committing to a $15 million stock purchase. Lin, a Taiwan-based drug developer, owns 77% of Belite going into the IPO and will still control more than half of the shareholder voting power once the offering is complete.