Clinical Trial News
PAN Foundation Study Reveals 'C' Grade for U.S. Healthcare Access, Highlighting Systemic Disparities
- A comprehensive national survey by PAN Foundation gives U.S. healthcare access a 'C' grade (75.8), revealing significant barriers particularly affecting marginalized communities and chronic disease patients.
- Insurance-related treatment access received a concerning 'D-' grade (62.8), with Hispanic, Native American, Pacific Islander, and LGBTQIA+ patients experiencing the most severe challenges.
- The study found that 36% of patients had to take financial measures to afford medications, while 48% faced logistical barriers in accessing care, demonstrating widespread healthcare accessibility issues.
Dermata Therapeutics Advances Phase 3 Trial for Novel Once-Weekly Acne Treatment DMT310
- Dermata Therapeutics reports steady enrollment progress in its Phase 3 STAR-1 clinical trial for DMT310, a once-weekly topical acne treatment derived from freshwater sponge technology.
- The company expects to complete enrollment by end of 2024 with topline results anticipated in Q1 2025, positioning DMT310 as a potential first-line treatment for the 32 million diagnosed acne patients in the US.
- Dermata continues partnership discussions for its DMT410 program, which uses Spongilla technology for topical delivery of botulinum toxin, and recently received a Japanese patent for DMT410 in hyperhidrosis treatment.
AI Revolutionizes Drug Discovery: Industry Leaders Share Latest Advances at London Conference
• Leading pharmaceutical companies including GSK, Schrödinger, and Insilico Medicine showcase how AI and machine learning are transforming the drug discovery process, with potential to create a $50 billion market in the next decade.
• Advanced AI platforms like Schrödinger's Autodesigner demonstrate remarkable efficiency, generating 118,000 drug candidate ideas in one day compared to 317 ideas from traditional crowdsourcing methods over two weeks.
• Companies are leveraging AI across multiple areas including target discovery, molecular design, and clinical trial simulation, with Insilico Medicine expanding to over 30 drug development programs in just four years.
Clinical Trials Support Services Market Set to Reach $47.1 Billion by 2032 Amid Growing Outsourcing Trend
• The global clinical trials support service market is projected to grow from $25.2 billion in 2023 to $47.1 billion by 2032, representing a 7.22% CAGR driven by increasing trial complexity and R&D investments.
• Pharmaceutical companies are increasingly outsourcing clinical trials to specialized CROs, with studies showing outsourcing can reduce Phase III trial costs by up to 41% compared to in-house execution.
• Patient-centric approaches are reshaping the clinical trials landscape, with diversity in trial participation rising from 20% in 2019 to 35% in 2022, potentially accelerating drug time-to-market by six months.
Elixir Medical's DynamX BTK System Receives FDA Breakthrough Device Designation for Chronic Limb-Threatening Ischemia
- Elixir Medical's DynamX BTK System receives FDA Breakthrough Device Designation for treating below-the-knee arterial disease in chronic limb-threatening ischemia (CLTI) patients.
- The DynamX Bioadaptor platform aims to restore vessel function by providing dynamic support during healing and maintaining an open lumen in affected vessels.
- The breakthrough designation expedites the review process, acknowledging the technology's potential to address unmet needs in treating severe peripheral arterial disease.
- Clinical data has demonstrated the Bioadaptor's ability to achieve high acute lumen gain and restore vessel motion, potentially improving outcomes in BTK revascularization.
Scandion Oncology's SCO-101 Shows Promise in Metastatic Colorectal Cancer Phase II Trial
- Scandion Oncology's CORIST Phase II trial update reveals early signs of SCO-101 efficacy in metastatic colorectal cancer (mCRC).
- Optimized dosing of SCO-101 with FOLFIRI demonstrates encouraging pharmacokinetic data and biomarker potential.
- Patients with UGT1A1 wildtype showed a median Progression Free Survival of 7.04 months and a median Overall Survival of 13.74 months.
- Scandion Oncology plans to expand Part 3 data to further optimize dosing for a randomized Phase IIb study.
Corvus Pharmaceuticals Updates on Clinical Trials and Financials for 2023
Corvus Pharmaceuticals reported a net loss of $6.7 million for Q4 2023, with R&D expenses totaling $4 million. The company is preparing for Phase 3 trials of soquelitinib for PTCL and a Phase 1 trial for atopic dermatitis in 2024, highlighting significant market opportunities and clinical progress.
Lenvatinib-Pembrolizumab Combo Misses Survival Endpoints in Endometrial Cancer Trial
The phase III LEAP-001 trial revealed that the combination of lenvatinib and pembrolizumab did not meet survival endpoints compared to chemotherapy as a first-line therapy for advanced or recurrent endometrial cancer. However, it showed promise in specific subgroups, including those with deficient mismatch repair (dMMR) and patients who had prior neoadjuvant/adjuvant chemotherapy.
FDA Accepts Journey Medical's NDA for DFD-29 (Minocycline Hydrochloride) for Rosacea Treatment
- The FDA has accepted Journey Medical's NDA for DFD-29 (minocycline hydrochloride modified release capsules, 40 mg) for treating rosacea in adults.
- The PDUFA goal date is set for November 4, 2024, indicating the timeline for the FDA's decision on the drug's approval.
- DFD-29 demonstrated statistically significant superiority over Oracea and placebo in Phase 3 trials, reducing inflammatory lesions and erythema.
- If approved, DFD-29 could be the only oral medication addressing both inflammatory lesions and erythema associated with rosacea.
Highlighted Clinical Trials:
Journey Medical Corporation
Posted 3/29/2022
Journey Medical Corporation
Posted 3/14/2022
Acelyrin's Lonigutamab Shows Promise in Thyroid Eye Disease, Challenging Amgen's Tepezza
- Acelyrin presented proof-of-concept data for lonigutamab, a subcutaneous treatment for thyroid eye disease (TED), demonstrating similar efficacy to Amgen's Tepezza.
- In a small study, lonigutamab showed improvements in clinical activity score (CAS) and eyeball protrusion, with a favorable safety profile and no reports of hyperglycemia or hearing impairment.
- Acelyrin plans to advance lonigutamab into registrational studies in the second half of the year, aiming for a monthly dosing schedule to compete in the TED market.
- The company's CEO emphasizes the potential of lonigutamab and izokibep to significantly improve patient care, supported by a strong cash position for multiple registration programs.