Founded in 2008, Samumed has spent most of its lifetime working under the radar. It came out of the shadows in 2016 with a war chest of $220 million drawn from investors including Ikea’s private venture arm and some very wealthy individuals along with a pipeline of drugs it says can reverse aging.
“People label us as an anti-aging company sometimes, but we consider our platform to be ‘de-aging,’” Samumed CEO Osman Kibar told FierceBiotech. “That is, to actually restore youth, to go back to peak health.”
The San Diego-based biotech is targeting the Wnt pathway to create regenerative medicines that, in Kibar’s words, treat patients so they won’t be patients any longer.
Take Samumed’s lead program, lorecivivint, which is in phase 3 for knee osteoarthritis. There is no treatment for osteoarthritis that reverses damage to the joint, so doctors focus on managing symptoms: They prescribe exercise and weight loss to improve muscle strength and reduce burden on joints as well as drugs such as painkillers, anti-inflammatory meds and cortisone injections. Some patients may eventually undergo joint repair or replacement surgery.
Lorecivivint is designed to fix joint damage, so patients don’t need to go through all that.
A phase 2 proof-of-concept study reported (PDF) in 2017 tested the drug in one knee in 455 patients. If the patient had disease in both knees, the investigators treated the more painful one. One year after treatment, X-rays showed that a single injection of the drug increased the “medial compartment joint space width” in patients with osteoarthritis in one knee—in other words, it grew cartilage.
The total population—which included patients with disease in both knees—saw "clinically meaningful improvements” in pain and function scores, but those changes didn’t reach statistical significance. Samumed pointed out that this wasn’t unexpected, as these patients might feel “diffusion of sense of pain from the untreated joint” or put more weight on their treated leg, negating some of the treatment’s benefits.
Nevertheless, Samumed figures the data paint lorecivivint’s potential as a disease-modifying drug for osteoarthritis.
“If you look at other OA drugs, every single one of them is either a painkiller or an anti-inflammatory. But after taking those, patients remain patients. They are still in pain once the drug wears off,” Kibar said. “In our case, the idea is to grow cartilage such that the overall health of the joint is restored.”
By Kibar’s count, lorecivivint has been tested in upward of 800 patients from phase 1 through phase 2b. And it will be tested in 725 more: Samumed just kicked off a 56-week phase 3 study designed to show that lorecivivint can indeed change the course of knee osteoarthritis.
In addition to knee osteoarthritis, lorecivivint is in phase 1 trials for degenerative disc disease, with trials in other kinds of osteoarthritis following close behind.
“We are going to start a phase 2 study in hand OA, expand into hip OA and we have muscle and bone programs in preclinical now. If we are able to restore the health of each of these tissues, the major components of the musculoskeletal system, then we should be able to reverse the clock on the physical health of everyone—not just patients,” Kibar said.
"Even if you’re not a patient—you've not gone to the doctor to get diagnosed with a certain disease—a 60-year old is not at the same level of health as that person was when she was 20 years old. It's our longer-term vision, or aspiration," he added.
Others before Samumed have tried to drug the Wnt pathway, but found out, in Kibar’s words, that “safety and efficacy were mutually exclusive.” So why does Samumed think it will succeed where others have failed?
One word: targets.
Targeting Wnt can be tricky, Kibar said, “because Wnt receptors have multiple purposes and the Wnt pathway is diverse enough, rich enough, that it always finds a way to bypass your drug intervention, which makes the efficacy go down.”
What’s more, hitting Wnt receptors hard can backfire. A drug may have its intended effect, but it may disrupt other processes, leading to side effects and safety concerns. So, instead of aiming at Wnt receptors on the cell membrane, Samumed’s drugs target CLK and DYRK, kinase enzymes that are upstream of the Wnt pathway.
“Our approach to drugging the Wnt pathway is as natural as it gets because we are not fighting the body’s own machinery or telling it to do something it wasn’t doing anyway,” Kibar said. “Instead, once we bring a certain signaling level back into balance, the progenitor stem cells and all the associated biological processes, they kick into autopilot and then the body knows exactly how to restore health.”
“Because we’re not going against the current but rather working with the body’s own machinery, both the hardware and the software, we are able to achieve such safety,” he said.
In addition to lorecivivint, Samumed has a treatment for androgenetic alopecia in phase 3 followed by earlier-stage programs in solid tumors, Alzheimer’s disease and idiopathic pulmonary fibrosis.
Samumed is Kibar’s third company. As a doctoral student at the University of California, San Diego he co-founded two startups—antenna-maker E-Tenna and cancer diagnostics company Genoptix, which was snapped up by Novartis for $470 million in 2011 and then sold on to NeoGenomics by way of two private investment firms.
“That’s when I got the bug,” he said. “I decided to move to New York and joined a private equity fund.”
“The amount of money we were managing on the private side was large, so we couldn’t move to earlier, seed-stage deals. We had to move to later-stage deals. One morning, I woke up, I was an investment banker,” Kibar said. “We had very little to do with technology."
So, he left. Taking his experience looking at business plan after business plan, Kibar hashed out “a smarter way to access technologies” and started his own incubator.
After assessing other people’s companies using that method, Kibar wondered, why not use it to find a technology he could run a company around?
The story is long, and Kibar declined to discuss specifics—but it involves Pfizer and its incubator, lawsuits and a startup named Witherix that would eventually become Samumed, according to a 2016 Forbes report.
“Pfizer provided us with the initial funding, but after that, there was a litigation—and I'm not at liberty to discuss the details—but at the end, we parted ways completely, so Pfizer was out of the picture completely. They don’t have any equity, no technology rights, no IP rights at the end, as of now,” Kibar said.
After its breakup with Pfizer, Samumed had to go out and get some cash. But it didn’t go the conventional route of courting biotech-focused venture capitalists. Instead, Samumed has pulled capital from some unconventional sources including sovereign funds, family offices, the venture arm of furniture giant Ikea, a single VC firm—Vickers Venture Partners—and what it calls “high net worth individuals.”
"I didn’t think the traditional biotech investors would be a good match for us because VCs and PEs, they need to raise their own funds every two to three years. Their timelines are much quicker in terms of arriving at a meaningful exit, whether that exit is an IPO or a partnership with a Big Pharma,” Kibar said.
A modest round might have bankrolled a program or two, but Kibar wanted to build out a platform that could be applied to many Wnt-related diseases. After disclosing that it had raised $220 million in 2016, Samumed went out and bagged a whopping $438 million in August 2018. This provided the runway to “move our later stage programs to commercialization, as well as expand on our earlier stage science and clinical portfolio,” Kibar said at the time.
Samumed expects its phase 3 osteoarthritis study to read out by the end of 2020 and hopes to submit lorecivivint for FDA approval in the first quarter of 2021. Its alopecia treatment is close behind, with approval anticipated in late 2021 or early 2022. As for its oncology program, the company aims to start an expansion study in pancreatic cancer this year.
“Depending on how that goes, we’re looking at—hopefully—the first half of 2021 for our first approval in oncology,” Kibar said.
Once it’s got a couple of approvals under its belt, Samumed’s plan is to “book revenue for about six to 12 months, and then take the company public.
“We’re probably looking at three to four years, depending on the market conditions, where we will be looking for an IPO,” Kibar said.