Little Evelo sees big promise in its first cut of data from a tiny study on atopic dermatitis
Anyone putting together an early-stage trial involving 24 patients with a big-market disease like atopic dermatitis wants to know one thing: Do they have a drug that’s active, with real potential as a therapy?
Evelo $EVLO just posed that question, and the answer in the data, says chairman David Epstein, is yes.
“The drug starts to work at 2 weeks,” Epstein says as he looks at the data. “That’s really fast.”
In a mega-market field like severe eczema, the blockbusters post pivotal numbers involving big groups of patients as they line up to take a shot at Dupixent. And it takes some awesome results to be competitive in a field of powerful biologics.
But little Evelo, with a market cap that’s likely below what those Phase IIIs cost, is competing for a whole different segment. And this data on 24 patients, they believe, offer actual human evidence that their microbiome strategy has a real chance of making it among a much larger number of patients with mild to moderate forms of AD as well as other inflammatory conditions that are all linked to the same triggers.
The bottom line on the data was statistical significance on 2 key scores in a placebo comparison:
EASI (62% difference, p=0.034) and the percentage change in IGA*BSA (71% difference, p=0.019)…At day 56, 10/16 patients in the active group showed improvements in EASI score, with 4/16patients having achieved an EASI50 clinical response, 3 of which achieved at least an EASI75, compared to 0/7 ofpatients in the placebo group.
It was also proven tolerable with no serious adverse events.
All of that is critical as the team at Evelo pursues mid-stage work on a drug that takes a page from nature and develops a book of data on this lead anti-inflammatory treatment.
As Epstein explains it, the mucosal lining of the stomach contains a hidden mucosal microbiome, and certain bacterial strains can directly speak to the immune system.
“We selected our strains that increase or decrease cytokines,” he says.
And in this instance you get an inhibitory effect on the TH2 inflammatory response that drives this disease among certain people.
So they developed this drug that only works in the gut, reducing the risk of any systemic safety issues. The data won’t work in severe cases, he adds, but the mild to moderate group represent the lion’s share of this market — and that’s just where they’re aimed.
This is simply a preliminary indication of efficacy, a proof of concept study, of course. And the journey ahead is long and highly risky. But the evidence that they could be on the right track was worth a 15% spike to the admittedly beaten-down value of the shares.
So how do you pay to get a drug like this through a very expensive pivotal effort?
Epstein, a Big Pharma vet with plenty of experience on that side of the industry, says that “based upon previous discussions in the pharma industry, we’re quite certain that pharma companies will want to talk to us.”
The microbiome field overall has had a mixed record on the investor front, but Epstein also points out that Wall Street pays attention when the data are right, as Seres recently demonstrated.
Besides that, Evelo is a Flagship startup, which routinely enjoys raising big sums for the platform companies they back. And Epstein points to multiple potential readouts in not just anti-inflammatory areas, but oncology as well — where researchers are looking at how you can fight cancer with their technology.
Evelo is pinning its hopes for big ambitions on a small study. But at this important milestone, Evelo believes there’s good reason to think big.