Suzetrigine

Latigo Biotherapeutics thinks it can one-up Vertex Pharmaceuticals’ recently approved Journavx, which ignited the non-opioid landscape for treating pain. The Los Angeles-area biotech is testing a similar type of small molecule, called a Nav1.8 inhibitor, like Vertex’s landmark drug. To prove whether it has the best-in-class medicine, investors have backed Latigo with another $150 million. The company disclosed the Series B Monday morning. Endpoints News reported on the biotech’s plans for the financing round last month. Latigo broke cover last February with $135 million after a few years in stealth mode. It’s quickly accelerated in the time since, hiring a new CEO, chief medical officer and finance chief, as well as instituting new board members, including former Horizon CEO Tim Walbert as chair. The startup is in Phase 2 with LTG-001 for acute pain and Phase 1 with LTG-305 for chronic pain. Aside from Vertex and Latigo, other startups are in the Nav1.8 arena, like SiteOne Therapeutics . “Journavx’s approval was a very clear signal from FDA that they’re leaning in,” CEO Nima Farzan said in an interview. “They gave them, in a lot of ways, a good label for the data they had generated. Having, for example, full acute pain, not just post-surgical pain [and] not having a restriction on days of use.” “You clearly see the regulatory agency leaning in on that. That’s very positive,” Farzan continued. “Yet there are still very clear opportunities for innovation and a potential best-in-class.” The onset of efficacy and restrictions on drug-drug interactions, with hepatic and renal side effects, in Journavx’s label “leave room for innovation,” Farzan said. The new funding will allow Latigo to collect Phase 2 and early Phase 3 data in acute pain, Farzan said. The biotech will have to run multiple Phase 3 trials but won’t conduct them concurrently as a pharmaceutical giant with larger firepower might be able to do, he said. The Series B will also help Farzan and the team collect early efficacy results in chronic pain. Meanwhile, the 45-employee biotech continues its drug discovery hunt in acid-sensing ion channels, or ASICs. Latigo can get into Phase 3 on its own in acute pain but might eventually seek a partner to help it approach the more difficult chronic pain setting, he said. They’ve got a “robust” manufacturing process in place with external help, the CEO said. Blue Owl Capital led the Series B. Latigo’s investor base also includes Deep Track Capital, Access Biotechnology, Qatar Investment Authority, Cormorant Asset Management, Sanofi Ventures, Rock Springs Capital, UPMC Enterprises, Kern Capital, Westlake BioPartners, Foresite Capital, 5AM Ventures and Alexandria Venture Investments. In the meantime, Farzan will be keeping a close eye on how Journavx’s approval and the broader non-opioid pain field pan out. “Are we going to start to see states coming up with policies trying to push even more patients away from an opioid?” he said. He pointed to measures that California has put in place that require prescribers to fill out a “complicated” form if they want their patients to get an opioid. “States are putting barriers in front of opioid prescriptions, and I’m wondering if those will even increase now that there are other options available,” Farzan continued. “Obviously that’s going to be a little bit longer term.” As for Vertex, company leadership has said they’ve been encouraged by conversations so far around the uptake of their medicine, approved Jan. 30. “There was some news in the press last week about ongoing conversations we have with Optum, not complete yet, but I think positive that these are occurring so rapidly,” Vertex CFO Charles Wagner said on March 10 at the Leerink Partners Global Healthcare Conference in Miami. New York and Arkansas have already provided coverage for Journavx, he said. “We have a lot to go, but the early signs are really encouraging,” Wagner said at the conference.

Latigo Biotherapeutics, a private drug company developing experimental pain medicines, has closed another nine-figure fundraising round.Asset manager Blue Owl Capital led the $150 million Series B round. As part of the raise, Kevin Raidy, a senior managing director at Blue Owl, has joined Latigos board of directors. More than half a dozen other new backers participated in the financing, as did existing investors 5AM Ventures, Foresite Capital, Alexandria Venture Investments and the firm that created Latigo, Westlake Village BioPartners.Latigos research mostly focuses on NaV1.8, a tube-shaped protein embedded in the outer casings of cells. When the body gets injured, these proteins act like alarm bells that blare pain signals to the brain. Silencing them can provide pain relief.In late January, Vertex Pharmaceuticals Journavx became the first pain medication targeting NaV1.8 to gain approval from the Food and Drug Administration. While Journavx faces substantial commercial challenges namely a pain relief market thats been skewed toward the use of cheap opioids analysts still expect it to eventually reach billions of dollars in sales.Smaller biotechnology companies like Latigo and SiteOne Therapeutics bet theres room on the market for their drugs, too. Tens of millions of people in the U.S. alone suffer from chronic pain. Millions more each year experience the short-lived acute pain typically felt after an operation or accident.NaV1.8 drugs work differently than opioids and, so far, dont appear to carry the addictive risks. Healthcare experts say such options could be extremely valuable given the U.S. remains mired in an opioid overdose crisis. And at least some politicians agree. A new federal law that went into effect this year aims to amend Medicare so patients can more easily access and afford certain non-opioid pain drugs.Latigo hopes to be on that list one day. The companys most advanced candidate, code-named LTG-001, is in a Phase 2 clinical trial, where researchers are evaluating its use alleviating the acute pain from wisdom teeth removals.CEO Nima Farzan expects results from that study to come in the back half of this year. Data from late-stage experiments that will test the drug in patients who just underwent either a tummy tuck or a bunion removal should be available early next year, he said.Latigo is working on at least two other NaV1.8 drugs geared towards chronic pain. The first, LTG-305, is in an early-stage study of healthy volunteers. The second, LTG-321, is a follow-on compound that, according to Farzan, has unique scaffolding which may make it more potent than its predecessor.Farzan said the new funding gives Latigo a substantial cash runway that should keep it operational into next year, at least until the company has Phase 3 data for LTG-001 and whats known as proof-of-concept data for LTG-305. Latigo closed a Series A round totaling $135 million last year.Not long ago, a startup that raised hundreds of millions of dollars and ushered drugs to mid-stage testing had a relatively easy path to an initial public offering. But a dramatic downturn in the biotech stock market over the last few years has made this journey far more fraught. Twenty four biotechs went public last year, a steep drop off from the more than 100 that did in 2021.Those that were able to pull off an IPO generally havent fared well either. Of last years class of 24, all but two are trading below their offering price.Often, public markets are the only fundraising source substantive enough to get young drugmakers through the larger, pricier studies needed to secure approval. But the size of Latigos latest fundraising round means the company doesnt have to race to an IPO, Farzan said.We can take our time. It's not right now. The markets are a little choppy, he added. We'll be responsible. We'll take a look. And when we think the backdrops relevant and interesting, it's something we would consider. But there are no immediate plans, given the current backdrop.If Latigos lead candidate ultimately gains approval, it would likely compete against Vertexs in the acute pain setting. There, Vertex already looks to be making some commercial inroads. Journavx got its first nod from a major health insurer this month, with UnitedHealth Groups pharmacy benefit manager placing the drug on some of its commercial formularies in an interim decision while a formal review continues.Jefferies analyst Michael Yee also highlighted in a note to clients Friday that Journavx prescriptions grew from 44 to 606 a 14-times increase between the first and second weeks of the drugs launch.Going against a deep-pocketed rival can be daunting. Farzan acknowledges Latigos investors are looking at the success of Vertex and using that as a reference for us.Still, he sees two areas where Journavx has left room for Latigo to compete. One is in how fast its able to reduce pain. The other is in the breadth of patients who might benefit. The hope, according to Farzan, is Latigos therapies will have fewer drug-drug interactions, or maybe help certain harder-to-treat populations, like those with impaired livers.The good news is that one quarter or two quarters of sales at launch is probably not the biggest thing especially for a hospital product, especially for a company like Vertex, which is not a Pfizer or Merck when it comes to commercializing. They've historically been in much more niche markets, Farzan said.Now, over a couple years, if you're not seeing the uptake, or you're seeing really great uptake, that will make, certainly, some impact. '