Clinical Trial News

Milestone Pharmaceuticals announced positive results from Ji Xing Pharmaceuticals' Phase 3 trial of etripamil nasal spray for paroxysmal supraventricular tachycardia (PSVT) in China, meeting primary and secondary endpoints with significant efficacy and safety. The trial aligns with Milestone's RAPID Phase 3 Study. Milestone and Ji Xing have a licensing agreement for etripamil in Greater China, with potential milestone payments and royalties.

Alopexx, Inc. receives investment from Biotech Consortia, Inc. to advance AV0328, a broad-spectrum anti-microbial vaccine targeting PNAG, with potential to treat bacterial, fungal, and parasitic infections. AV0328 completed Phase I trials, showing tolerance and antibody induction against PNAG-expressing pathogens, with an affordable cost of $1 per dose.

Ventyx Biosciences initiates Phase 2a trial of VTX3232, an oral NLRP3 inhibitor, in early Parkinson’s disease patients, aiming to assess safety, tolerability, and biomarkers. Topline results expected in 2025.

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Palatin Technologies Inc received FDA approval for PL9643 Phase 3 trials for dry eye disease, with MELODY-2 and MELODY-3 set to begin in Q4 this year. PL9643 aims to address DED inadequacies with early efficacy and good tolerability, with potential NDA submission in H1 2026 if trials succeed. MELODY-1 showed significant symptom relief and safety.

The DEA approved Takeda Pharmaceuticals to increase Vyvanse production by 24% to address ongoing ADHD drug shortages, with a 13,478-pound increase including 3434 pounds for domestic and 10,313 pounds for foreign demand.

AI's potential in drug discovery is highlighted by Recursion Pharmaceuticals' Phase 2 SYCAMORE trial for REC-994, targeting cerebral cavernous malformation, which met safety endpoints but showed mixed efficacy. Despite AI's ability to analyze vast datasets, challenges include data scarcity for rare conditions and predicting drug efficacy accurately. Experts suggest developing more complex AI models and combining AI with traditional techniques to advance drug discovery.

Obeticholic acid (Ocaliva) faces EU ban for lack of benefit in early-stage PBC, but Advanz Pharma secured a temporary suspension of the ban. Patients protest, highlighting the drug's critical role when initial treatments fail.

Strides Pharma Science's subsidiary, Strides Pharma Global Singapore, received USFDA approval for generic Theophylline Extended-Release Tablets, 300 mg and 450 mg, bioequivalent to Schering Corp's THEO-DUR. Indicated for chronic asthma and lung diseases, the tablets will be manufactured in Bengaluru, with a market size of ~$11.5 million.

Drug-drug interactions with statins and calcium channel blockers did not significantly alter colchicine's safety and efficacy in COVID-19 patients, suggesting pharmacokinetic changes do not translate into clinically significant effects.