Enveric Biosciences Announces Positive Preclinical Data for EV102 Radiodermatitis Drug Candidate

Rhea-AI Summary

Enveric Biosciences (NASDAQ: ENVB) announced promising preclinical results for its product EV102, aimed at treating radiodermatitis in cancer patients. In rodent models, EV102 demonstrated a nearly 50% reduction in skin redness and overall dermatitis severity, as well as a decrease in symptom duration. These findings are critical as radiodermatitis affects up to 95% of radiation therapy patients. The company plans to advance EV102 to a Phase I clinical study in the second half of 2022, underpinning its commitment to improving the quality of life for cancer patients.

Positive

• Significant reduction in dermatitis severity reported, nearly 50% decrease in skin redness.
• Decrease in overall duration of dermatitis symptoms observed in preclinical trials.
• Plans to move EV102 to a Phase I clinical study in the second half of 2022, indicating progress.

Negative

• None.

-  Significant Reduction in Dermatitis Severity Demonstrated

NAPLES, Fla., Nov. 18, 2021 /PRNewswire/ - Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and cancer support care therapies by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, today announced that EV102, the Company's cannabidiol (CBD) based product in development for topical prescription treatment of radiodermatitis, has demonstrated significant and meaningful reduction in dermatitis severity, skin redness, and duration in a preclinical rodent model.

"Cancer patients around the world suffer the harsh side effects of various anti-cancer treatments," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "Radiodermatitis, the most common side effect of radiation therapy, is a physical skin irritation with symptoms ranging from red rash to open wounds.  EV102 was topically applied during a daily treatment regimen and resulted in a nearly 50% reduction in redness scoring severity. Similar results were obtained for overall dermatitis severity, which includes desquamation (skin peeling) and ulceration as part of a composite score.  Extending these promising results was an observed reduction in overall duration of dermatitis symptoms." The significance of these preclinical findings will be evaluated in a planned human evaluation in 2022.

"At Enveric, we are focused on improving quality of life for cancer patients. The encouraging results of EV102 positions us to take the next steps in bringing safer and more effective prescription treatment options to market. We expect results from the preclinical study to support our efforts to move EV102 to a Phase I clinical study, targeted to begin in the second half of 2022," concluded Dr. Tucker.

Radiodermatitis (also called radiation dermatitis) is a condition caused by the high-energy X-rays delivered during radiation therapy. It affects nearly 95% of patients who receive radiation for cancer treatment, with approximately 85% of patients having moderate-to-severe skin reactions. Radiodermatitis usually begins to occur within 1-4 weeks of treatment and persists for the duration of radiation therapy. The severity of the skin reactions ranges from mild erythema (red rash) to dry desquamation (itchy, peeling skin) to the more severe moist desquamation (open wound) and severe ulceration. Radiodermatitis can be similar to the discomfort of a mild-to-severe sunburn: painful, difficult to move or wear clothing, itching, and peeling skin. In the most severe cases, ulceration can occur, disrupting the treatment.

About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is an innovative biotechnology company developing a next-generation mental health and oncology treatment clinical discovery platform, leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body. Enveric's robust pipeline supports drug development from the clinic to commercialization for millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more. For more information, please visit www.enveric.com.

Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans", " expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric's ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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SOURCE Enveric Biosciences

FAQ

What is EV102 developed by Enveric Biosciences?

EV102 is a cannabidiol-based product aimed at treating radiodermatitis, a common side effect of radiation therapy in cancer patients.

What were the results of the preclinical trials for EV102?

The preclinical trials showed a nearly 50% reduction in dermatitis severity and skin redness, along with a decrease in symptom duration.

When does Enveric plan to begin human trials for EV102?

Enveric Biosciences plans to initiate Phase I clinical trials for EV102 in the second half of 2022.

How common is radiodermatitis among cancer patients?

Radiodermatitis affects nearly 95% of patients undergoing radiation therapy, with about 85% experiencing moderate to severe reactions.

What is the significance of the EV102 trial results for cancer patients?

The results indicate potential for improved treatment options that could enhance the quality of life for cancer patients suffering from radiation-induced skin reactions.