Clinical Trial News

Ocuphire Pharma has initiated the VEGA-3 phase 3 trial of phentolamine ophthalmic solution 0.75% for presbyopia treatment, aiming for a non-invasive, convenient alternative. The trial follows positive results from the VEGA-2 study, which demonstrated rapid onset, favorable safety profile, and sustained effect. VEGA-3 will evaluate 545 participants with presbyopia, with top-line data expected in 2025, potentially supporting a supplemental New Drug Application.

Atsena Therapeutics announced 12-month safety and efficacy data from its Phase I/II trial of ATSN-101, a gene therapy for Leber congenital amaurosis caused by biallelic mutations in GUCY2D, published in The Lancet. ATSN-101 demonstrated durable, clinically significant improvements in vision at the high dose and was well-tolerated. This marks the first gene therapy treatment for LCA1, with potential for a Phase III trial.

Hilleman Laboratories' partner Bharat Biotech launched Hillchol oral cholera vaccine, using a single, genetically engineered Hikojima strain. Approved in India, Bharat Biotech aims for WHO prequalification for global distribution. The vaccine, developed through collaboration, addresses global cholera vaccine shortages.

THINK Surgical's TMINI Miniature Robotic System receives FDA 510(k) clearance for use with Zimmer Biomet's Persona Knee System, offering both exclusive and open implant platform options for total knee arthroplasty.

Moderna's mRNA vaccine for mpox shows higher efficacy than Bavarian Nordic's Jynneos in preventing severe disease and reducing virus levels in monkeys, according to a study published in Cell. The vaccine also reduced viral replication and lesion formation, potentially limiting spread. Moderna is currently conducting a Phase I/II trial in the UK, with data expected in mid-2025.

Largest phage therapy trial for UTI treatment shows promise.

Lupin's share price surged over 1% to a 52-week high after USFDA approval for its generic Mirabegron tablets for overactive bladder. Lupin and Zydus are the only companies with approval for both 25 mg and 50 mg strengths, enjoying 6 months exclusivity. Lupin also launched doxorubicin hydrochloride liposome injection in the US.

Dr. Roos Jansåker's clean-bracket study assesses light-activated antibacterial treatment's efficacy in enhancing dental plaque control for adolescents with braces. The Lumoral device, utilizing PBM, aims to reduce plaque and gingival inflammation, potentially benefiting periodontal tissues. Despite PBM's positive effects in healing and reducing pain, its use in dentistry remains limited. The study highlights the challenges of oral hygiene with braces, including increased risk of caries and gingivitis, and the potential of Lumoral to mitigate these risks. The trial results are anticipated in early 2025.

Tisagenlecleucel (Kymriah) is increasingly used in earlier lines of therapy for pediatric and young adult relapsed/refractory B-ALL, reducing HSCT use and high disease burden. Data from the CIBMTR registry show a decrease in late-line tisagenlecleucel use and high disease burden rates, with improved morphological CR rates and favorable long-term safety profiles.

NOX inhibitors, including Calliditas Therapeutics' setanaxib, show potential in treating fibrotic diseases and cancers by reducing ROS levels, thereby allowing CD8+ T-cells to penetrate tumors and enhance immune response. Setanaxib has shown promising results in Phase II trials for squamous cell carcinoma of the head and neck, with plans for further trials in primary biliary cholangitis and Alport Syndrome.