Lexicon Pharmaceuticals has initiated patient dosing in the Phase 2 clinical study (called RELIEF-PHN 1) of LX9211 for the treatment of post-herpetic neuralgia. Shares closed 3.3% higher on Thursday.
Lexicon’s (LXRX) LX9211 is a potent, orally delivered, selective small molecule inhibitor of adaptor associated kinase 1 (AAK1) and has received Fast Track designation from the U.S. Food and Drug Administration for the development in diabetic peripheral neuropathic pain.
The Phase 2 study, which involves 74 patients, is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of post-herpetic neuralgia.
The primary efficacy endpoint in the trial is the change from day 1 to week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale.
Commenting on the study, Lexicon’s Praveen Tyle stated “People who develop shingles often suffer with persistent pain for months to years after the rash clears with limited treatment options. We believe LX9211 has the potential to offer a novel therapeutic approach to treating post-herpetic neuralgia. We look forward to completing this study and our other proof-of-concept study of LX9211 in diabetic peripheral neuropathic pain toward the end of next year.”
On Dec. 8, 2020, Citigroup analyst Yigal Nochomovitz upgraded Lexicon to Buy from Hold and raised the price target to $6 from $2.10 after adding sotagliflozin for heart failure in type 2 diabetes (T2D) to his model following positive data from the SOLOIST and SCORED studies.
In a note to investors, Nochomovitz stated that while he understands that questions on the regulatory path remain, he believes “the strength of the CV outcomes data as evidenced by back-to-back NEJM articles last month should go a long way in supporting a label for sota in T2D patients with HF [Heart Failure] (SOLOIST population).” The analyst feels that partnership discussions should regain momentum following this favorable data.
“We see sota in T2D patients with CKD (SCORED population) as upside to our valuation and do not currently include this indication in our model. Lexicon expects to meet with FDA to discuss the data in early 2021,” Nochomovitz added.
Overall, the Street has a cautiously optimistic outlook on Lexicon. The Moderate Buy analyst consensus is based on 3 Buys, 1 Hold and 1 Sell. The average price target of $4 indicates upside potential of 17% in the 12 months ahead. Shares plunged 17.6% in 2020.