FDA greenlights SciSparc’s Phase IIb Tourette Syndrome study By Investing.com

TEL AVIV – SciSparc Ltd. (NASDAQ: SPRC), a pharmaceutical company specializing in central nervous system disorders, has received confirmation from the U.S. Food and Drug Administration (FDA) to proceed with Phase IIb clinical trials for its drug candidate SCI-110 in adult patients with Tourette Syndrome (TS). This follows the FDA’s approval and is seen as a significant milestone for the company.

The upcoming trial will evaluate the efficacy, safety, and tolerability of the oral treatment SCI-110. It will be conducted at three leading global centers: the Yale Child Study Center at the Yale School of Medicine in Connecticut, Hannover Medical School in Germany, and the Tel Aviv Sourasky Medical Center in Israel. Institutional Review Board approvals have been secured from all sites, in addition to the necessary federal administrations.

Patients aged 18 to 65 will be randomized to receive either SCI-110 or a matched placebo. The primary goal is to measure the change in tic severity using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. Additionally, the trial will monitor the frequency of serious adverse events in the SCI-110 and placebo groups.

SciSparc’s CEO, Oz Adler, expressed the company’s belief in the unmet medical need for effective TS management. Adler highlighted the Phase IIa trial results, which showed a 21% average tic reduction, with nearly 40% of participants experiencing over 25% reduction. Based on these findings, SciSparc anticipates SCI-110 could be a favorable therapy for TS.

The company’s focus extends to other cannabinoid pharmaceuticals, including treatments for Alzheimer’s disease, agitation, Autism Spectrum Disorder (ASD), and status epilepticus. SciSparc also holds a controlling interest in a subsidiary selling hemp seed oil-based products online.

The information in this article is based on a press release statement from SciSparc Ltd. The forward-looking statements in the press release are subject to risks and uncertainties, and actual results may vary from those projected. SciSparc’s past scientific research and clinical trials do not guarantee future outcomes. The company’s Annual Report on Form 20-F, filed on April 1, 2024, contains further details under the “Risk Factors” section. SciSparc has no obligation to update any forward-looking statements made.

In other recent news, SciSparc Ltd. has been active on several fronts. The company announced its intention to divest its 52.73% stake in MitoCareX Bio Ltd., potentially fetching up to $8 million. The divestiture begins with the sale of 27% of its shares for $700,000 in cash. Additionally, the company has received FDA approval to proceed with Phase IIb clinical trials for its drug candidate SCI-110, intended for the treatment of adults with Tourette Syndrome.

SciSparc has also extended a $1.85 million bridge loan to AutoMax Motors Ltd., negating the need for previously agreed closing financing in the merger plan between the two entities. The company has also inked an exclusive patent license agreement with Polyrizon Ltd. for the out-licensing of its SCI-160 program aimed at treating pain.

The company recently initiated a trial for its proprietary SCI-210 therapy, aimed at treating symptoms of autism spectrum disorder in children, and 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 recent developments in SciSparc’s operations.

InvestingPro Insights

SciSparc Ltd.’s recent FDA approval to proceed with Phase IIb clinical trials for SCI-110 comes at a critical time for the company, as reflected in its financial metrics and market performance. According to InvestingPro data, SciSparc’s market capitalization stands at a modest $0.81 million, indicating the company’s current small-cap status in the pharmaceutical sector.

Despite the positive news on the clinical trial front, SciSparc faces financial challenges. The company’s revenue for the last twelve months as of Q4 2023 was $2.88 million, with a substantial revenue growth of 113.73% over the same period. However, this growth is tempered by an operating income margin of -200.52%, suggesting significant ongoing research and development costs typical of pharmaceutical companies in the clinical trial phase.

InvestingPro Tips highlight that SciSparc “holds more cash than debt on its balance sheet” and “liquid assets exceed short term obligations,” which could provide some financial flexibility as the company advances its clinical trials. However, the tip that the company is “quickly burning through cash” aligns with the negative operating income and reflects the capital-intensive nature of drug development.

The stock’s performance has been challenging, with InvestingPro data showing a one-year price total return of -92.86% as of the most recent data. This decline is further emphasized by the InvestingPro Tip noting that the stock is “trading near 52-week low.” Despite these headwinds, analysts anticipate that SciSparc will be profitable this year, which could be a positive sign for investors looking at the company’s long-term potential.

For investors seeking a more comprehensive analysis, InvestingPro offers 16 additional tips for SciSparc, providing a deeper understanding of the company’s financial health and market position as it progresses through this crucial clinical trial phase.

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