Mavoglurant

A small Oakland, CA-based biotech hoping to take on the sprawling landscape of substance use disorders and addiction has reeled in $70 million. The drug development startup, named Tempero Bio, secured the Series B to collect Phase 2 trial data for its daily pill called TMP-301. 8VC led the funding round, which was disclosed Monday morning. Other investors include founder Aditum Bio and Khosla Ventures. Tempero expects to have Phase 2 data in alcohol use disorder (AUD) toward the end of this year and mid-stage data in cocaine use disorder (CUD) around the middle of 2026, president and chief scientific officer Ricardo Dolmetsch told Endpoints News in an exclusive interview. The funding provides runway through 2027, he said. The AUD Phase 2 began late last year. The CUD proof-of-concept study will start this year after an ongoing drug-drug interaction study wraps up soon, Dolmetsch said. “It’s always been a giant unmet medical need. It’s highly stigmatized,” Dolmetsch said. “People have a lot of shame, and we devote a lot of resources to punishing people or trying to disincentivize them, but it doesn’t really solve the problem for the patient or for the family.” Dolmetsch, who left his CSO post at gene therapy maker uniQure in 2023, spent more than half a dozen years heading up global neuroscience drug development at Novartis. While there, he worked under the direction of then-CEO Joe Jimenez and Mark Fishman, who was president of the Novartis Institutes for BioMedical Research. Jimenez and Fishman reunited to form Aditum Bio, a biotech investor and incubator that sets up companies around clinical-stage assets or drugs about to enter human studies. They’re working out of their third fund, which closed at $428 million earlier this year. The former Novartis executives started Tempero around a licensing deal for an asset developed by Nxera (then known as Sosei Heptares) — a mGluR5 negative allosteric modulator called TMP-301. They’ve now brought in chief medical officer John Wagner, a former Takeda SVP and CMO at Koneksa, who is working on creating digital biomarkers for new drugs. It’s a sort of comeback story for Dolmetsch and the team. While at Novartis, Dolmetsch worked on a mGluR5 program called mavoglurant. They took the experimental medicine through a series of clinical studies in cocaine use disorder , obsessive-compulsive disorder, fragile X syndrome and Huntington’s disease. “That actually showed efficacy in a study in patients with cocaine use disorder,” Dolmetsch said. But “mavoglurant had its own limitations and also it was off patent.” Tempero hopes that by inhibiting mGluR5, they’ll be able to restore balance to the brain’s reward nucleus, which in turn would reduce cravings, increase enthusiasm for daily activities and hamper dysphoria, Dolmetsch said. With TMP-301, they have a new investigational pill in the class. Dolmetsch said TMP-301 is more potent and has better pharmacokinetics than mavoglurant, which is now housed at Stalicla, a small Swiss startup that in-licensed the program from Novartis for up to $270 million . Stalicla has said it has US government funding and can take mavoglurant into Phase 3 for cocaine use disorder. The company’s website is under construction and on Stalicla’s LinkedIn page, the startup says it is “now raising series C funding to advance both verticals,” referring to its work in both autism spectrum disorder and substance use disorder. Stalicla’s CEO, Lynn Durham, didn’t immediately respond to an Endpoints inquiry about the company’s status on Friday or last month. Other companies are exploring mGluR5 for various conditions, like Noema Pharma in trigeminal neuralgia and seizures in tuberous sclerosis complex, and Addex in post-stroke and traumatic brain injury recovery . In its Phase 2 AUD study, Tempero hopes to show a reduction in heavy use days, Dolmetsch said. The field has moved from abstinence being the main goal to harm reduction and harm mitigation, or the prevention of binging and daily drinking, the CSO said. The same goes with cocaine and other abused drugs, he added. Naltrexone, an AUD and opioid use disorder drug, can reduce drinking by about 10% but is not very well tolerated, Dolmetsch said. “This is an area sort of like obesity. The thing that is going to be transformative is something that has a really dramatic effect,” the Tempero executive said. “I don’t think the world really needs a medicine that just reduces your drinking a little bit or reduces your dysphoria a little bit or reduces your drug use a little bit.” “I’ve worked a lot of my life on addiction, and I found that people often recognize that it’s a big unmet need, and then very rapidly after that, they’re like, ‘Well, you know, but addicts don’t like taking their medicines,’ or ‘They like being addicts,'” Dolmetsch said. “There are many, many misconceptions about what it’s like to have one of these disorders.” The round took about eight months to come together and closed toward the end of 2024, he said, adding that it’s been difficult, historically, to garner investor and pharma interest in the addiction space. “It started off being really difficult, and then suddenly it became really easy,” Dolmetsch said. Part of that is likely due to the hype that has built up around the weight loss and diabetes medicines from Eli Lilly and Novo Nordisk for their potential in treating addiction, among other conditions. Jimenez’s Aditum had put about $25 million into Tempero prior to the Series B, the CSO added. Jimenez previously told Endpoints that he sees Tempero’s work in addiction paralleling that of the obesity drug market, which has taken off in recent years thanks to the success of the GLP-1 class. “I really believe that once we prove this can be a multibillion-dollar business, there’s going to be pharma companies that take a hard look at it,” Jimenez told Endpoints in October 2023. Dolmetsch said he could envision Tempero going all the way to the market on its own. “Given the relative absence of drugs in the addiction space, we think there’s a lot of enthusiasm for having fairly accelerated registration timelines,” he said. “There is a real potential to develop a company here that not only develops the medicines but also develops the infrastructure that allows you to treat people with substance use disorders,” he said. “And the post-Covid world is one where people are much more willing to go online and be connected to caregivers and get a prescription and then have their prescriptions sent home.” If approved, Dolmetsch pictures TMP-301 being a drug that people use for a certain period of time to reduce their alcohol or drug abuse to the point where they have a “better relationship” with substances, he said. Then, they could eventually be weaned off the medication. But it would likely depend on individual circumstances, as they don’t want people to relapse, the executive added.