Clinical Trial News
DoxyPEP Shows Promise in Preventing STIs Among High-Risk Groups, but Concerns Over Resistance Remain
• DoxyPEP, a post-exposure antibiotic regimen, demonstrates efficacy in preventing bacterial STIs like syphilis and chlamydia, particularly among gay and bisexual men and transgender women.
• Studies show varying effectiveness against gonorrhea, potentially due to differing rates of antibiotic resistance across regions and populations.
• Concerns persist regarding the potential development of antimicrobial resistance with widespread doxyPEP use, necessitating careful monitoring and targeted implementation.
• Guidelines vary, with some agencies recommending doxyPEP for high-risk groups while others urge caution due to resistance concerns and limited data on cisgender women.
Genetic Variations in Serotonin Receptors Influence Psychedelic Drug Potency
- A new study identifies that genetic variations in serotonin (5-HT2A) receptors may alter the potency of psychedelic drugs, impacting individual responses.
- Researchers found that different gene forms of the 5-HT2A receptor exhibit significant differences in drug potency when binding to psychedelics like psilocin and mescaline.
- The study suggests that genetic factors should be considered in future clinical trials evaluating the therapeutic potential of psychedelic drugs for psychiatric applications.
- These findings may help explain the wide range of responses observed in patients treated with psychedelics, with some experiencing significant benefits and others none.
Sutro Biopharma and Merck Advance Novel Cytokine Derivative into Phase 1 for Solid Tumors
- Sutro Biopharma announces the dosing of the first patient in a Phase 1 study for a novel cytokine derivative therapeutic developed in collaboration with Merck.
- The therapeutic is designed for the treatment of advanced or metastatic solid tumors, marking a significant step in the collaboration between the two companies.
- Sutro Biopharma will receive a $10 million payment from Merck as a result of achieving this clinical milestone, per the 2018 agreement.
- The collaboration leverages Sutro's XpressCF® and Xpress CF+® platforms for cytokine derivative development, with Merck holding exclusive worldwide rights to resulting therapeutic candidates.
Senate Finance Committee Revises Medicare Drug Negotiation Policy, Removing Automatic Inclusion of Insulins
- The Senate Finance Committee's updated drug pricing draft removes insulins as a category automatically subject to Medicare price negotiation, potentially altering the landscape for diabetes treatment access and pricing.
- Under the revised timeline, Medicare will begin negotiating prices for 10 high-spending Part D drugs in 2026, expanding to include Part B drugs in 2028, with the first negotiation process starting September 2023.
- Avalere analysis estimates that 100 drugs across multiple therapeutic areas would be subject to Medicare negotiation during 2026-2031, representing approximately 45% ($106 billion) of all Medicare Part B and D drug spending.
Sling Therapeutics Initiates Enrollment in Phase 2b LIDS Clinical Trial for Thyroid Eye Disease
Sling Therapeutics has begun enrolling participants for a global Phase 2b LIDS clinical trial to evaluate the safety, pharmacokinetics, and efficacy of linsitinib, an oral IGF-1R inhibitor, in treating active, moderate to severe thyroid eye disease (TED). This trial marks a significant step towards reducing the treatment burden for TED patients.
Highlighted Clinical Trials:
Sling Therapeutics, Inc.
Posted 7/1/2022
Visual Field Telemedicine Shows Promise for Glaucoma Monitoring
- A 12-month visual field telemedicine (VFTM) trial demonstrated good compliance (75%) among glaucoma patients using weekly home monitoring.
- Test reliability of the VFTM was 65%, which is significantly lower than the 85% reliability observed with in-clinic Humphrey Field Analyzer (HFA) tests.
- VFTM results showed good concordance with in-clinic assays, suggesting it's a viable option for monitoring glaucoma progression between visits.
- The study found that VFTM detected clinical progression in two eyes, aligning with findings from HFA-guided progression analysis.
Spectral Medical's Tigris Trial Shows Early Promise for PMX in Septic Shock
- Spectral Medical's Tigris trial, evaluating Polymyxin B Hemoperfusion (PMX) for septic shock, has randomized 40 patients across 14 sites, showing steady recruitment progress.
- An early case study from the University of Michigan demonstrated rapid patient improvement and quicker ICU discharge following PMX administration.
- The Tigris trial aims to reduce 28-day mortality in septic shock patients using PMX hemoperfusion compared to standard care, addressing a $1.6 billion unmet need.
- Spectral Medical is advancing towards FDA submission for PMX, supported by Breakthrough Device designation and a commercial partnership with Baxter.
CardioFocus Advances in Pulsed Field Ablation Technology for Atrial Fibrillation Treatment
CardioFocus, Inc. has announced significant progress in the development of its next-generation Pulsed Field Ablation (PFA) technology for treating atrial fibrillation (Afib), including the formation of a clinical advisory board, filing of key patents, and completion of initial pre-clinical studies. The company is leveraging its HeartLight X3 System to address current PFA catheter shortcomings, aiming for first human use in early 2023.
FDA Authorizes Novavax's Protein-Based COVID-19 Vaccine for US Adults
- The US Food and Drug Administration has authorized Novavax's protein-based COVID-19 vaccine for adults, making it the fourth COVID-19 shot available in the United States.
- Novavax's vaccine uses traditional protein-based technology that has been employed for decades against diseases like hepatitis B and influenza, potentially appealing to the 27 million unvaccinated American adults skeptical of mRNA platforms.
- The US government has secured 3.2 million Novavax doses to be released after quality testing, though European uptake has been limited with only about 242,000 doses administered since its December launch.
FDA Grants Orphan Drug and Fast Track Designations to CV-01 for Recurrent Glioblastoma Treatment
The FDA has granted orphan drug and fast track designations to CV-01, Alpheus Medical's novel sonodynamic therapy delivery platform, for treating recurrent glioblastoma. This innovative approach aims to non-invasively target and eradicate solid tumors, offering new hope for patients with this aggressive brain cancer.
Highlighted Clinical Trials:
Alpheus Medical, Inc.
Posted 6/29/2022