LAUSANNE, Switzerland - AC Immune SA (NASDAQ: NASDAQ:ACIU), a company specializing in neurodegenerative disease therapies, announced that its Alzheimer's disease treatment candidate, ACI-35.030 (JNJ-2056), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The designation is aimed at expediting the development and review of drugs intended to treat serious conditions and fill an unmet medical need.
The treatment targets phosphorylated Tau (pTau), a pathological form of the Tau protein associated with Alzheimer's disease. The Phase 2b clinical trial, named ReTain, is currently enrolling participants with preclinical Alzheimer's disease, who are cognitively normal but have Tau pathology. The trial is being fully funded and conducted by Janssen Pharmaceuticals, Inc., a Johnson & Johnson company.
Dr. Andrea Pfeifer, CEO of AC Immune, stated that the Fast Track designation recognizes the potential value of their anti-pTau active immunotherapy. The ReTain study marks the first instance of an active immunotherapy being tested on a preclinical Alzheimer's population. Pfeifer highlighted the potential for therapeutic advantages and benefits in terms of convenience and access that this treatment modality could offer.
The ReTain trial is designed to assess whether JNJ-2056 can delay or prevent the onset of cognitive impairment in preclinical Alzheimer's disease through the inhibition of pathological Tau propagation. Around 500 participants will be randomized to receive either JNJ-2056 or a placebo, with treatment lasting up to four years. Primary and secondary endpoints will include cognitive decline measurements and Tau pathology assessment through PET imaging.
ACI-35.030 has demonstrated in earlier clinical studies the ability to induce a robust antibody response against pTau, which is thought to contribute to Tau aggregation and disease progression. The candidate stems from AC Immune's proprietary SupraAntigen® platform.
AC Immune, with a pipeline featuring several therapeutic and diagnostic programs for neurodegenerative diseases, continues its commitment to innovation in Alzheimer's treatment and prevention.
This press release is based on a press release statement.
In other recent news, AC Immune SA has been the subject of significant developments. The company received a 'Buy' rating and a price target of $8.00 from BTIG, emphasizing its extensive pipeline which focuses on detecting and clearing toxic proteins related to neurodegenerative diseases. The firm anticipates the first plaque removal data from AC Immune's lead program, an anti-Aβ vaccine, to be released in 2024.
Additionally, AC Immune has entered into a global option and license agreement with Takeda Pharmaceutical Company (NYSE:TAK) Limited for the development of ACI-24.060, a potential Alzheimer's disease treatment. The agreement could potentially earn AC Immune up to approximately $2.1 billion in additional milestones. The ongoing ABATE Phase 1b/2 trial, evaluating the safety and efficacy of ACI-24.060, has reported encouraging safety profiles with no concerns raised thus far.
InvestingPro Insights
As AC Immune SA (NASDAQ: ACIU) advances its Alzheimer's disease treatment candidate, investors are closely watching the company's financial health and market performance. According to InvestingPro data, AC Immune holds a market capitalization of approximately $331.66 million USD. Despite the challenges in the biotech sector, the company has shown a remarkable revenue growth of 276.14% in the last twelve months as of Q1 2024.
InvestingPro Tips suggest that AC Immune holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability. Additionally, analysts are anticipating sales growth in the current year, aligning with the company's recent advancements and FDA Fast Track designation for its Alzheimer's treatment candidate. However, it is important to note that analysts do not anticipate the company will be profitable this year, and the company suffers from weak gross profit margins, as evidenced by a gross profit margin of -277.66% in the same period.
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