4D Molecular Therapeutics Interim Clinical Data from the On-going Phase 1/2 Clinical Trial of 4D-710 for Cystic Fibrosis Lung Disease to be Presented at NACFC 2022

Rhea-AI Summary

4D Molecular Therapeutics (Nasdaq: FDMT) will present interim clinical data from its Phase 1/2 trial of 4D-710 at the North American Cystic Fibrosis Conference (NACFC) from November 3-5, 2022. The presentation will cover safety, tolerability, delivery, and CFTR transgene expression in cystic fibrosis patients. Following the presentation, a conference call will be hosted on November 3rd at 4:30 PM ET to discuss results. 4D-710 aims to treat cystic fibrosis via aerosol delivery, potentially benefiting a wide range of patients with various CFTR mutations.

Positive

• Interim clinical data from Phase 1/2 trial of 4D-710 to be presented at NACFC.
• 4D-710 targets a broad range of cystic fibrosis patients with various CFTR mutations.
• Conference call scheduled to discuss interim results may enhance investor engagement.

Negative

• None.

4D Molecular Therapeutics to host a conference call on November 3rd, 4:30 pm E.T.

EMERYVILLE, Calif., Oct. 26, 2022 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced that interim clinical data from the Phase 1/2 clinical trial of 4D-710 will be presented during a symposium at the upcoming North American Cystic Fibrosis Conference (NACFC), being held November 3-5, 2022. The presentation will include a summary of 4D-710 safety, tolerability, delivery and CFTR transgene expression in patients with cystic fibrosis who have been enrolled on cohort 1 of the dose exploration portion of the clinical trial (n=3; 1E15 vg).

NACFC Oral Presentation Details for 4D-710:

Title: Update on AAV-mediated CFTR gene delivery programme (4D-710)

Session Title: Design of Clinical Trials to Evaluate Nucleotide-based Interventions

Presenter: Jennifer L. Taylor-Cousar, MD, MSCS, Professor, Departments of Medicine and Pediatrics, and Co-Director, Adult Cystic Fibrosis Program, Director, Cystic Fibrosis Foundation Therapeutics Development Center, National Jewish Health; Lead Principal Investigator, 4D-710 Phase 1/2 Clinical Trial

Session Date/Time: November 3^rd, 2022 from 9:45 – 11:45 am E.T.

Conference Call Information

4D Molecular Therapeutics will host a conference call and live webcast on November 3^rd, 2022 at 4:30 pm E.T to further discuss the interim clinical data presented at NACFC. Registration and dial-in for the conference call may be accessed through 4D Molecular Therapeutics website under Events & Presentation in the Investors section through the following link: https://ir.4dmoleculartherapeutics.com/events. An archived replay of the webcast will be available following the event.

The presentation from NACFC will also be available on the 4D Molecular Therapeutics website under Scientific Presentations: https://4dmoleculartherapeutics.com/technology/scientific-presentations.

About 4D-710 and Cystic Fibrosis

4D-710 is comprised of our targeted and evolved vector, A101, and a codon-optimized microCFTR transgene. 4D-710 has the potential to treat a broad range of patients with cystic fibrosis, independent of the specific CFTR mutation, and is designed for aerosol delivery to achieve CFTR expression within lung airway epithelial cells. 4D-710 is being initially developed in the approximately 10-15% of patients whose disease is not amenable to existing medicines targeting the CFTR protein. In patients with CFTR mutations whose disease is amenable to modulator medicines, the improvement in lung function is variable. We therefore expect to potentially develop 4D-710 in this broader patient population, as a single agent and/or in combination with these CFTR modulator small molecule medicines.

Cystic fibrosis is a major inherited disease caused by mutations in the CFTR gene. According to the CF Foundation, more than 30,000 people in the United States and more than 70,000 people worldwide are living with cystic fibrosis, with approximately 1,000 new cases of cystic fibrosis diagnosed in the United States each year. Cystic fibrosis is a multisystem disorder affecting the lungs, digestive system and reproductive tract. Lung disease is the leading cause of morbidity and mortality. Cystic fibrosis causes impaired lung function, inflammation and bronchiectasis and is commonly associated with persistent lung infections and repeated exacerbations due to the inability to clear thickened mucus from the lungs. Patients with cystic fibrosis require lifelong treatment with multiple daily medications. The complications of the disease result in progressive loss of lung function and hospitalizations, and ultimately lead to end-stage respiratory failure.

About 4DMT

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. 4DMT seeks to unlock the full potential of genetic medicines using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent targeted and evolved vectors for use in our products. The company is initially focused on five clinical-stage products in three therapeutic areas for both rare and large market diseases: ophthalmology, cardiology (including Fabry disease) and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered at relatively low doses through clinically routine, well tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. The five 4DMT product candidates in clinical development are: 4D-150 for wet AMD, 4D-310 for Fabry disease, 4D-710 for cystic fibrosis, 4D-125 for XLRP, and 4D-110 for choroideremia.

4D-150, 4D-310, 4D-710, 4D-125, and 4D-110 are in clinical trials and have not yet been approved for marketing by the US FDA or any other regulatory authority. No representation is made as to the safety or effectiveness of 4D-150, 4D-310, 4D-710, 4D-125, and 4D-110 for the therapeutic use for which they are being studied. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.

Contacts:

Media:

Katherine Smith
Evoke Canale
Katherine.Smith@evokegroup.com

Investors:

Mike Zanoni
VP, Investor Relations & Corporate Affairs
mzanoni@4dmt.com 

FAQ

What is the purpose of the 4D-710 clinical trial?

The 4D-710 clinical trial aims to assess safety, tolerability, and the ability of the treatment to deliver CFTR transgene expression in cystic fibrosis patients.

When will the interim data for 4D-710 be presented?

Interim clinical data for 4D-710 will be presented on November 3rd, 2022, at the North American Cystic Fibrosis Conference.

What are the implications of the 4D-710 trial results for cystic fibrosis patients?

Positive trial results could lead to a new treatment option for cystic fibrosis patients not responsive to existing therapies.

How can I access the conference call for 4D-710?

The conference call can be accessed through the 4D Molecular Therapeutics website under Events & Presentation in the Investors section.