Zelira Upbeat On Positive Feedback For Cannabis-Based Autism Drug

Zelira Therapeutics Ltd (ASX:ZLD) has highlighted significant advancement in its cannabinoid-based HOPE® autism drug program following a successful meeting with the United States Food and Drug Administration (FDA).

Calling it a “major milestone”, the company received a positive and clear written response from the FDA to preliminary questions submitted ahead of the meeting.

Following the positive feedback, Zelira is poised to progress the HOPE program toward an investigational new drug (IND) submission.

Looking ahead, this marks a significant step forward in the development of treatments for irritability associated with autism spectrum disorder (ASD).

At the indices, the market welcomed the news with shares trading as high as A$0.61 during mid-day trade, up 27% from previous close.

ZLD share price chart

Key Highlights

FDA’s response provided essential clarity on all matters presented, said the company.

In particular, it defines the indication for treatment of irritability associated with patients with ASD, Phelan-McDermid Syndrome (PMS) and Smith-Magenis Syndrome (SMS).

During the meeting, Zelira discussed the design of the IND opening phase 1 study in healthy volunteers.

In response, the FDA provided guidance on the study design, aiming to evaluate the safety and pharmacokinetics of the proposed doses of ZEL-HOP1, ensuring a robust framework for further clinical development.

“Crucial step forward”

Zelira managing director Oludare Odumosu said:” We are particularly pleased with the FDA’s prompt and detailed response to our preliminary questions.

“The clarity provided by the FDA, especially regarding the indication and study design, is incredibly positive for our company and the HOPE® SPV program.

“This meeting represents a crucial step forward in our mission to develop effective treatments for autism-related irritability.”

About Zelira

Zelira Therapeutics is a leading global cannabinoid-based biopharmaceutical company with access to the world’s largest and fastest growing markets.

The company owns a portfolio of proprietary revenue generating products and a pipeline of candidates undergoing clinical development that are positioned to enter global markets.

Zelira is focused on developing branded cannabinoid-based medicines for the treatment of a variety of medical conditions in its Rx business, including insomnia, autism and chronic non-cancer pain.



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