Shares of AbCellera Biologics Inc. soared by more than 25 per cent in value Monday in pre-market trading after the Vancouver antibody developer published positive results from a clinical trial assessing the efficacy of its treatment for women experiencing moderate or severe hot flashes during menopause.

The positive trial results could position the drug to be a best-in-class nonhormonal therapy with fewer health risks than competing treatments and represent a significant milestone by the company whose stated goal is to build Canada’s first homegrown pharma giant.

“Since founding the company, our vision has been to build Canada’s first global biotech company, a company that is known for innovation, a company that can repeatedly invent, develop and commercialize breakthrough medicines,” with its multi-faceted technology platform for discovering antibodies, chief executive officer Carl Hansen said on a conference call with analysts to discuss the results. “Obviously nothing is certain but today it sure looks like we’ve found our first winner.”

AbCellera said its drug, called ABCL635, was found during an 80-person trial to deliver significant improvements in the frequency and severity of hot flashes compared to those who were taking a placebo. The company said those who took the drug experienced a mean 83 per cent reduction of the number of moderate and severe hot flashes over the trial’s four-week span, compared to a 33 per cent reduction for those on the placebo.

Thirty-seven per cent of those taking the drug experienced no moderate or severe hot flashes at all during the four-week period, while 61 per cent experienced a reduction of 90 per cent or more. The company plans to publish further data after 12 weeks of trial results.

Those on the experimental drug experienced a 58 per cent mean reduction in the severity of hot flashes after four weeks, compared to just 12 per cent in the placebo group, and more than one-quarter of the women experienced a complete reduction in the severity level of their hot flashes.

The efficacy data “is practically off the chart on everything measured” and are better than other non-hormone therapies for hot flashes on the market – Astellas Pharma’s Veozah and Lynkuet by Bayer – said Cantor Fitzgerald analyst Steve Seedhouse in a research note.

AbCellera’s drug still needs to succeed in an expanded efficacy trial before gaining regulatory approval, a considerable challenge that has felled many promising late-stage drug candidates. But if it prevails, ABCL635 could be a significant new treatment option for menopausal women, who are currently either prescribed hormonal therapies, or the once-daily pills from Bayer and Astellas that have caused side effects in some users, including liver toxicity and gastrointestinal issues.

By contrast, the AbCellera drug is expected to be delivered once monthly by self-injection, similar to how GLP-1 drugs like Ozempic are delivered. Because the antibody is not processed by the liver it has not shown any toxicity issues in safety and efficacy results to date. Side effects in the trial were largely limited to temporary mild headaches and fatigue in 13 per cent of patients that took the drug. There were no serious or severe adverse events, and patients on the drug experienced meaningful improvements in their sleep scores.

AbCellera’s success in the clinic comes six years after the company rapidly discovered an antibody treatment for people hospitalized with the COVID-19 virus, which received emergency authorization for sale by regulators in the U.S. and Canada.

Partner Eli Lilly & Co. took the drug to market in 2020 and AbCellera ultimately earned nearly US$1-billion in royalties during the drug’s brief commercial life. The company went public late that year was briefly worth more than US$15-billion before its stock began a long, slow decline. Investor interest picked up this year as AbCellera published promising safety data for ABCL635 and completed enrolment for the trials, which were conducted at 13 locations across four Canadian provinces.

Mr. Hansen said the company expects to bring at least two more drugs into clinical development next year.

more to come