UK biotech Levicept said its first-in-class biologic can help ease pain and stiffness in patients with moderate to severe osteoarthritis, according to mid-stage data released Tuesday.
The Phase 2 study, which investigated its pain drug dubbed LEVI-04, used an osteoarthritis index called WOMAC to measure pain, stiffness and joint function in patients who have the degenerative joint disease in the knee.
In the 17-week primary endpoint, all three LEVI-04 doses offered at least a 50% mean reduction from baseline in WOMAC, with statistically significant differences over placebo, according to the company. The study recruited more than 510 patients, per a press release.
LEVI-04 inhibits neurotrophin-3 but does not impact the other three members in the family of neurotrophins, which includes nerve growth factor (NGF), CEO Eliot Forster told Endpoints News in an interview. NGF has been investigated as a target for other experimental drugs in pain.
But Forster pointed to the checkered history of anti-NGFs: These candidates led to joint deterioration, even in healthy individuals. In contrast, Levicept said LEVI-04 — in addition to being well-tolerated — did not increase joint deterioration compared with placebo, based on radiographic review in the Phase 2 trial.
The biotech also looked at LEVI-04’s peripheral nervous system effects, which have historically been observed with anti-NGFs. Its analysis did not raise red flags, Forster added. “So remember, NGF is ‘the good guy.’ If you switch off NGF and leave NT-3, ‘the bad guy,’ floating around, then of course you’ve got a double whammy,” he said.
Phase 3 plans
As for next steps, Levicept is in “dual tracks,” Forster said. The company is looking for a partner to help run a Phase 3 that would potentially investigate the drug in different types of joints, he said. “And if we do it ourselves, we’re likely to try and take a ‘biotech approach,’” he added, meaning that the late-stage trial would focus on osteoarthritis in the knee.
“The company’s well-funded. We can run for a long time without having raised money. But we can’t do Phase 3, so we need to raise money. We want to operate with a sense of urgency,” Forster said. Levicept closed a £35 million Series B raise in 2021 with support from Pfizer Ventures and Medicxi.
While the Phase 2 studied intravenous LEVI-04 administered once a month, the Phase 3 will look at a subcutaneous version, Forster said. “Patients will be able to pick up their meds from their physician, from their rheumatologist, and will be able to self-inject with [something like an] EpiPen,” he added.
The mid-stage trial investigated three doses — 0.3 mg/kg, 1 mg/kg and 2 mg/kg — but the subcutaneous version will likely be a flat dose and not by patient weight, Forster added. “We’re in the process of calculating what that [dose] will be but it will fit comfortably within the lower end of that [dose] range,” he said.