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Lexicon Pharmaceuticals was able to establish a deal with Novo Nordisk, whereby the big pharma obtained an exclusive, worldwide license for LX9851 for the treatment of patients with Obesity. This drug candidate is a small molecule inhibitor of Acyl-CoA Synthetase 5 or ACSL5. This plays a key role in the metabolic pathway in doing both regulating fact accumulation and handling energy balance.
Besides this, the candidate also can delay gastric emptying of the stomach and suppress a person’s appetite. There are a lot of obesity drugs in place, plus many in clinical development. However, there is something of key importance to note which is that both companies aren’t going to develop LX9851 alone to treat these obese patients. Instead, the ultimate end game goal is to combine the use of this drug with Novo’s WEGOVY [Semaglutide].
Speaking of which, preclinical in vivo efficacy data, which was presented at the Obesity Week 2024 conference showed that when Lexicon’s LX9851 was combined with Semaglutide, there was an improvement in terms of reducing weight in a significant fashion, reduced food intake and fat mass as well.
Based on the terms of this agreement, it was revealed that Novo Nordisk would retain an exclusive worldwide license agreement to develop, manufacture and commercialize LX9851 as a weight loss drug and other metabolic disorder indications. This won’t happen right away, because Lexicon is still responsible for completing the Investigational New Drug (IND) application-enabling activities for this drug. This is a pretty good deal for Lexicon and it is because it will wash its hands of this drug in terms of cost. The reason why is because Novartis is going to be responsible for carrying it forward in terms of clinical development. It will file the IND to get a phase 1 study going, fund further clinical development of LX9851 for starters. In the end, it will pretty much also be responsible for both manufacturing it and commercializing it.
The deal is a good one for Lexicon Pharmaceuticals, because it bolsters its cash on hand. Under the terms of the agreement made, it will receive upfront and near-term milestone payments of up to $75 million. This is small potatoes for big pharma and maybe not even all that much for a small pharmaceutical company. With that being said, if this drug can get through several phases of clinical development, plus ultimately be approved to treat obesity patients, then Lexicon could earn up to $ 1 billion in potential milestone payments.
Lexicon has a drug it is developing in its pipeline known as Pilavapadin (LX9211] for the treatment of patients with Diabetic Peripheral Neuropathic Pain (DPNP). This is an oral non-opioid drug being developed to treat these patients. It achieved some positive data showing a well-tolerated dose that these patients could take. In essence, the 10 mg dose of this drug was not only shown to be safe, but somewhat effective. It is key to note that this clinical candidate remains a huge risk. That’s because the primary endpoint of “average daily pain score”, wasn’t met in a statistically significant manner. Still, the plan is to have an end-of-phase 2 meeting with the FDA in hopes of being able to initiate phase 3 studies for this program. It believes that it could get such late-stage trials initiated this year in 2025. Furthermore, there is a catalyst for investors to be on the lookout for. It is expected that DPNP data from the phase 2 study will be released at a future medical meeting during this year.
This company’s pipeline is highly diverse. With that said, it is currently evaluating the use of sotagliflozin in the phase 3 pivotal study SONATA-HCM. This is a late-stage placebo controlled study looking to enroll up to a total of 500 patients with obstructive or nonobstructive hypertrophic cardiomyopathy or HCM.