MW Viking Therapeutics reports positive data from trial of treatment for rare metabolic disorder X-ALD

By Ciara Linnane

Viking, which is also developing a weight-loss pill, has a buy rating from all 13 analysts offering coverage

Viking Therapeutics Inc. on Wednesday reported positive data from an early-stage trial of a treatment for the rare, and often fatal, metabolic disorder X-linked adrenoleukodystrophy, or X-ALD.

San Diego-based Viking $(VKTX)$, which is also developing an oral weight-loss treatment, said the Phase 1b trial of VK0214, a novel small molecule agonist of the thyroid hormone receptor beta, achieved significant reductions in mean VLCFA levels at two doses evaluated.

VLCFAs, or very long-chain fatty acids, are deemed to be biomarkers of disease in patients with X-ALD. The treatment was well tolerated with more gastrointestinal events in the placebo group than those treated with the drug.

The trial enrolled adult male patients suffering from the adrenomyeloneuropathy $(AMN)$ form of X-ALD, who were divided into three cohorts; placebo, VK0214 20 mg daily and VK0214 40 mg daily.

The primary endpoint was to evaluate safety and tolerability over a 28-day dosing period. Secondary goals included an evaluation of the pharmacokinetics of VK0214 following 28 days. And one further exploratory objective was to evaluate the effects of VK0214 on plasma levels of VLCFAs in subjects with AMN.

"Patients receiving VK0214 demonstrated progressive improvement in plasma levels of very long chain fatty acids in the relatively brief treatment period evaluated in this study," Viking Chief Executive Brian Lian said in prepared remarks. "In addition, VK0214 continued to show benefits on broader plasma lipids, such as LDL-C, important for overall cardiometabolic health."

Viking will pursue further development of VK0214, Lian said.

X-ALD is characterized by a breakdown in the protective barriers surrounding brain and nerve cells that cause a buildup of VLCFAs, which cause symptoms including cognitive impairment, motor skill deterioration and even death. The disorder, caused by a gene mutation, is estimated to affect 1 in 17,000 births. There are currently no treatment options approved.

Viking's stock rose early in the day before turning down 3.8% in morning trade. The stock has gained 245% in the year to date on the back of excitement about the prospect of its weight-loss drug, while the S&P 500 $(SPX.UK)$ has gained 20.8%.

Maxim Group said Wednesday's data was positive but all focus is on the weight-loss pill.

"While the data is positive, we believe Viking may ultimately partner the product for further development," analysts Naz Rahman and Jason McCarthy wrote in a note to clients.

Maxim did not make any updates to its model or estimates, but reiterated its buy rating on the obesity treatment opportunity. All 13 analysts who cover the stock on FactSet have a buy rating.

The stock is widely viewed as a cheaper entry to the weight-loss-drug craze than market leaders Eli Lilly & Co. Inc. $(LLY)$ and Novo Nordisk $(NVO)$ (DK:NOVO.B). Like Lilly's weight-loss drug Zepbound, the product called VK2735 acts on two different gut hormones, GLP-1 and GIP.

The drug may also have a clear differentiator from the wildly popular treatments already on the market. Viking plans to explore monthly dosing of VK2735, CEO Brian Lian said on a July call with analysts.

Both Novo Nordisk's Wegovy and Lilly's Zepbound are once-weekly injections. Patients often don't adhere to weekly dosing, so a once-monthly option "may be a highly attractive proposition," Maxim analysts said at that time.

See now: Viking Therapeutics posts positive results for oral weight-loss drug. Analysts remain unanimous the stock's a buy.

-Ciara Linnane

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October 09, 2024 14:09 ET (18:09 GMT)

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