Xenon Pharmaceuticals Inc. XENE announced top-line data from the phase II proof-of-concept X-NOVA study, which evaluated its lead pipeline candidate, XEN1101, for the treatment of moderate-to-severe major depressive disorder (“MDD”).
The placebo-controlled, double-blind proof-of-concept X-NOVA study investigated the clinical efficacy, safety and tolerability of two doses of XEN1101 (10 mg and 20 mg) in 168 patients with moderate-to-severe MDD. The primary endpoint of the study was to see the change in the Montgomery-Åsberg Depression Rating Scale, or MADRS, at week six of treatment.
Data from the study showed that treatment with XEN1101 (10 mg) led to a mean reduction of 15.61, while the mean reduction was 16.94 in the XEN1101 (20 mg) group. The mean reduction in the placebo group was 13.90.
Though the data suggested a clear dose response and a clinically meaningful benefit, it was not statistically significant, as patients receiving the 20 mg dose of XEN1101 demonstrated a 3.04 difference from the placebo group.
Despite XEN1101 failing to achieve statistical significance versus placebo in the X-NOVA study, shares of Xenon were up 17.8% on Monday following the announcement of the news.
The stock has lost 13.5% so far this year compared with the industry’s decline of 22.9%.
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Per the company, XEN1101 achieved statistical significance on the pre-specified endpoint of the Hamilton Depression Rating Scale, or HAM-D17, at week six of treatment. This was probably as treatment with XEN1101 (20 mg) achieved statistical significance on the key secondary endpoint of a change in the Snaith-Hamilton Pleasure Scale or SHAPS.
Treatment with XEN1101 was generally well tolerated, with no serious adverse side effects being observed in the two treatment groups.
Per the company, through its unique mechanism, XEN1101 has the potential to address anhedonia, a common co-morbidity in depression. The company is actively exploring the future development of XEN1101 as a treatment for MDD and other neurological disorders.
XEN1101 is currently being evaluated in various phase III studies for the treatment of epilepsy.
In the absence of a marketed product, the successful development of XEN1101 remains the key focus area for this clinical stage biopharmaceutical company.
Zacks Rank & Stocks to Consider
Xenon currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. CTMX, Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, sporting a Zacks Rank #1 (Strong Buy) each.You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 16.9%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have lost 7.5%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 62 cents. Year to date, shares of PBYI have risen 6.1%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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