Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. in a deal worth $2.5 billion.
Upon closure of the deal, which is expected by the first quarter of 2025, Semnur plans to continue the road to potential commercialization for its lead candidate Semdexa.
Semdexa is an injectable corticosteroid gel formulation of dexamethasone sodium phosphate that’s meant to treat patients with moderate to severe lumbosacral radicular pain, or sciatica.
The condition causes pain in patients' lower back and hips, symptoms that are often treated with opioids, Semnur’s parent company Scilex Holding Company has previously noted.
In a phase 3 study of 401 patients, treatment with Semdexa triggered a “rapid onset” of pain relief and continued to reduce pain intensity for over one month, Scilex said in March 2022. If approved, the med would be the first cleared to specifically treat the condition.
In a pain field where UCB and Biogen have have come up short, Semdexa could represent a major commercial boon. The drug could rake in sales of $1.5 billion to $2 billion by the fifth year of launch in just the sciatica indication, Scilex has forecast, citing independent market research by Syneos Health Consulting.
The treatment holds an FDA fast-track designation, and a 700-patient trial needed to support a potential approval was previously projected to finish enrollment in 2025.
“With Semnur on its way to becoming a publicly-traded company, our unique model continues to demonstrate the multiple ways that we can unlock the value of Scilex and enhance our shareholders’ value,” Scilex’s CEO Jaisim Shah said in the company’s release. “I believe this business combination will enable us to advance our growth strategy, which includes gaining access to public markets and exploring potential partnerships and global pharma collaborations for our product candidate, Semdexa.”
Scilex, a former subsidiary of troubled Sorrento Therapeutics, also made its way to the U.S. public markets through a SPAC merger with Vickers Vantage Corp. in a deal that closed in 2022. The company now markets migraine treatment Elyxyb and gout flare preventative Glopera as well as pain patch ZTlido.