TEL AVIV - SciSparc Ltd. (NASDAQ: SPRC), a pharmaceutical company specializing in central nervous system therapies, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with Phase IIb clinical trials for its drug candidate SCI-110, intended for the treatment of adults with Tourette Syndrome (TS). This development follows the company's Investigational New Drug (IND) application submitted on August 23, 2024.
The upcoming trials will evaluate the efficacy, safety, and tolerability of SCI-110 through a randomized, double-blind study involving a 1:1 ratio of the drug and a matched placebo. The primary aim is to measure tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. Additionally, the trial will assess the frequency of serious adverse events in both the drug and placebo groups.
Trials are set to take place at three global centers of excellence, including the Yale Child Study Center at the Yale School of Medicine, the Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board approvals have been secured at all locations.
SciSparc's CEO, Oz Adler, expressed enthusiasm for reaching this milestone with SCI-110, emphasizing the company's commitment to providing novel treatments for central nervous system disorders. The swift FDA approval and positive outcomes from the previous Phase IIa trial strengthen the company's belief in SCI-110's potential as a safe and effective treatment for TS.
SciSparc, known for its focus on cannabinoid-based pharmaceuticals, also develops treatments for Alzheimer's disease, agitation, Autism Spectrum Disorder (ASD), and status epilepticus. The company maintains a controlling interest in a subsidiary that sells hemp seed oil products on Amazon (NASDAQ:AMZN) Marketplace.
The information in this article is based on a press release statement from SciSparc Ltd. It should be noted that historical results from scientific research and clinical trials do not guarantee future outcomes. SciSparc's forward-looking statements are subject to risks and uncertainties that could affect the company's actual results, performance, or achievements.
In other recent news, SciSparc Ltd. has made several significant strides in its operations. The pharmaceutical company has advanced its phase IIb clinical trial for SCI-110, a drug candidate aimed at treating Tourette Syndrome. The trial will evaluate the drug's efficacy, safety, and tolerability in adult participants.
Simultaneously, SciSparc has extended an additional $1.85 million bridge loan to AutoMax Motors Ltd., eliminating the need for previously agreed closing financing in the merger plan between the two entities. The company has also signed an exclusive patent license agreement with Polyrizon Ltd. for the out-licensing of its SCI-160 program, aimed at treating pain.
In addition, SciSparc has initiated a clinical trial for its proprietary SCI-210 therapy, aimed at treating symptoms of autism spectrum disorder in children. The company also announced the appointment of Professor Nir Peled, a renowned oncologist, to the scientific advisory board of its cancer-focused venture, MitoCareX Bio Ltd. These are the recent developments in SciSparc's operations.
InvestingPro Insights
As SciSparc Ltd. (NASDAQ: SPRC) advances its clinical trials for SCI-110, a drug candidate for Tourette Syndrome, the company's financial metrics and market performance provide additional context for investors. According to InvestingPro data, SciSparc holds a market capitalization of 0.86 million USD, which is reflective of the company's current valuation in the market. Notably, the company's Price / Book ratio, as of the last twelve months ending Q4 2023, stands at a low 0.11, suggesting that the stock may be undervalued compared to the company's net asset value.
Moreover, while SciSparc has experienced a significant 113.73% revenue growth in the last twelve months as of Q4 2023, it is important to note that the quarterly revenue growth for the same period showed a decline of 32.67%. This discrepancy highlights the volatility in the company's revenue streams, which could be a factor for potential investors to consider. Additionally, the company's stock price has been under pressure, trading near its 52-week low and experiencing a substantial price total return decrease of 93.38% over the last year.
InvestingPro Tips for SciSparc reveal a mix of potential strengths and concerns. The company holds more cash than debt on its balance sheet, which is a positive indicator of financial stability. However, analysts anticipate a sales decline in the current year, which could impact the company's financial growth. For those interested in a deeper analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/SPRC, which could provide further insights into SciSparc's financial health and market expectations.
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