Positive readout? Public offering: Viridian plans to raise $175M on eye disease therapy data
A year and a half after rebranding, Viridian Therapeutics appears to have found a path forward.
On Monday, the Waltham, MA-based biotech reported initial data from its Phase I/II trial of thyroid eye disease (TED) — and the results, while only in one of three treatment arms, look promising thus far. Later in the day, Viridian followed up with a public offering of $175 million in both common and preferred stock.
In a small cohort of a Phase I/II trial, 5 of 6 patients who got 10 mg/kg of Viridian’s thyroid eye disease candidate — an anti-IGF-1R antibody known as VRDN-001— responded to treatment, meaning they had a ≥2mm reduction in the bulging of their eyes, a common symptom of the disease, alongside at least a 2-point reduction (out of 7) on a composite score of TED-related symptoms. Two patients in the cohort received placebo.
In addition, three-quarters of patients who had double vision from TED saw symptoms resolved as well.
In this treatment arm, there were no serious adverse events or discontinuations reported, but two patients had muscle spasms and one had ringing in their ear, though none required additional intervention, the biotech said.
Viridian plans to read out the 20 mg/kg and 3 mg/kg arms of the trial later in the year.
Horizon’s Tepezza, also an anti-IGF-1R antibody, became the first approved treatment for thyroid eye disease in early 2020. Tepezza is one of Horizon’s top-selling drugs, bringing in almost $480 million last quarter. However, in Horizon’s Q2 call earlier this month, CEO Tim Walbert lowered 2022 sales predictions for the drug, down from around $4 billion to between $3.53 billion and $3.6 billion.
“We expected Tepezza trends to continue to show the positive progress based on the post-Omicron recovery and that didn’t happen,” Walbert said during the call.
Viridian CMO Barrett Katz said of VRDN-001:
These data exceeded our expectations and compare very favorably to Tepezza, the only approved therapy in TED. The significant improvement in signs and symptoms observed after only two infusions of VRDN-001 is remarkable. We plan to accelerate the start of our Phase 3 THRIVE program, now starting later this year, in a broad TED population of both active and chronic disease.
In addition to Viridian’s public offering of $175 million, underwriters can go back for another $26.25 million in shares of its common stock.
In 2020, Viridian, then known as miRagen, slashed its workforce in half, shuffled its executive leadership, and sidelined its discovery work. The penny stock biotech bought out Viridian Therapeutics, adopting its name and a new ticker symbol a few months later. Alongside the buyout and rebranding, what was formerly a microRNA biotech in miRagen pivoted its focus to Viridian’s TED pipeline.
In response to Monday’s readout, Viridian’s stock $VRDN has jumped nearly 60%, from around $15 to nearly $25 Tuesday morning.