BRISBANE, Calif. - Vera Therapeutics, Inc. (NASDAQ:VERA), a biotech firm specializing in immunological disease treatments, announced today that the FDA has granted Breakthrough Therapy Designation to its drug atacicept for treating IgA nephropathy (IgAN). This designation is based on Phase 2b ORIGIN trial data, indicating that atacicept could significantly improve upon existing therapies for IgAN, a serious autoimmune kidney disease.
The FDA's decision hinges on the trial's findings that atacicept may enhance kidney function, as evidenced by eGFR measurements, more effectively than current treatments. Dr. Marshall Fordyce, CEO of Vera Therapeutics, expressed optimism about atacicept's potential as a transformative therapy for IgAN patients.
The Phase 2b ORIGIN trial assessed atacicept's efficacy in maintaining eGFR over a 72-week treatment period. Patients initially underwent a 36-week double-blind phase, followed by a 36-week open-label extension with self-administered atacicept. Results showed eGFR stabilization, aligning with general population profiles rather than those with IgAN.
The trial, which included 116 patients at high risk of IgAN progression despite existing medication, met primary and secondary endpoints, demonstrating significant proteinuria reduction and eGFR stabilization through week 36. Atacicept's safety profile was similar to placebo.
Vera Therapeutics plans to release 96-week results from the Phase 2b trial later this year and anticipates primary endpoint results from the Phase 3 ORIGIN 3 trial in the first half of 2025 to support regulatory approval submissions for atacicept in IgAN.
The FDA's Breakthrough Therapy Designation aims to expedite the development and review of drugs for serious conditions where preliminary evidence suggests a substantial improvement over existing therapies. Atacicept's designation reflects its potential to meet this criterion for IgAN treatment.
The Phase 3 ORIGIN 3 trial is currently evaluating atacicept's safety and efficacy in a larger patient cohort, with a primary focus on proteinuria reduction and kidney function preservation. The trial consists of a 104-week double-blind treatment period, followed by a 52-week open-label extension and 26 weeks of follow-up.
This news is based on a press release statement from Vera Therapeutics.
InvestingPro Insights
Vera Therapeutics, Inc. (NASDAQ:VERA) has been a company of interest for investors following its recent FDA Breakthrough Therapy Designation. With a market capitalization of approximately $2.03 billion, the company is navigating a critical phase in its growth trajectory. Notably, InvestingPro data reveals that the company's Price / Book ratio stands at 5.74 as of the last twelve months of Q1 2024, indicating a valuation that is high relative to its book value. This could be reflective of the market's optimism about Vera's future prospects, particularly in light of the potential of its drug atacicept.
An InvestingPro Tip highlights that Vera holds more cash than debt on its balance sheet, which is a positive sign for investors concerned about the company's financial resilience. Moreover, the stock's Relative Strength Index (RSI) suggests it is in oversold territory, potentially indicating an opportunity for investors looking to capitalize on recent pullbacks.
However, investors should be aware that analysts have revised their earnings expectations downwards for the upcoming period, which could impact the stock's performance. Additionally, the company is not expected to be profitable this year, and it has been unprofitable over the last twelve months. These financial metrics are crucial for investors to consider as they assess the risk and potential of their investment in the context of Vera's product development timeline and market dynamics.
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