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Clinical Trial News

Dr Ashleys Limited Acquires Impact BioMedical in Strategic Reverse Merger to Accelerate Global Drug Development

  • Dr Ashleys Limited, a Hong Kong-based pharmaceutical company, announced a strategic reverse merger with Impact BioMedical Inc. (NYSE American: IBO) on June 21, 2025, creating a combined entity to be traded on NYSE American.
  • The merger combines Dr Ashleys' global manufacturing capabilities and over 300 million annual medical doses with Impact BioMedical's robust portfolio of 90+ patents across critical health areas.
  • Both companies focus on addressing infectious diseases including malaria, COVID-19, tuberculosis, and dengue fever, as well as cancer and gastrointestinal disorders.
  • The transaction requires regulatory approvals and Impact BioMedical shareholder approval, with the combined entity to be operated by Dr Ashleys' management team.

LifePlus Achieves Clinical Validation for Revolutionary Non-Invasive Glucose and Blood Pressure Monitoring Device

AI
  • LifePlus announced clinical validation of LifeLeaf®, the world's first non-invasive wearable for continuous glucose and blood pressure tracking, tested at Mayo Clinic, Cleveland Clinic, and other global centers.
  • The device achieved impressive accuracy with 10.8% MARD against blood glucose meters and 8.5% MARD against Dexcom G6, while demonstrating blood pressure monitoring accuracy within ±12.5 mmHg systolic and ±8.4 mmHg diastolic.
  • Clinical validation was supported by over 70,000 paired multi-biomarker datapoints from more than 500 subjects across 14 countries, with the device being 70% more cost-effective than current solutions.
  • LifePlus is initiating additional longitudinal outcome studies across multiple continents, targeting prediabetic and hypertensive populations to demonstrate early intervention benefits.

Candel Therapeutics Names Charles Schoch as Permanent CFO Following Successful $86M Capital Raise

  • Candel Therapeutics has appointed Charles Schoch as permanent Chief Financial Officer, transitioning from his interim role held since January 2024.
  • Schoch led the company through a successful $86 million capital raise following positive phase 3 results for CAN-2409 in localized prostate cancer in December 2024.
  • The appointment comes as Candel prepares for its Biologics License Application submission for CAN-2409 in localized prostate cancer and advances its multimodal immunotherapy pipeline.

BioStem Technologies Completes Enrollment in Diabetic Foot Ulcer Trial Testing Placental-Derived Allograft

  • BioStem Technologies has completed enrollment of 71 patients in its BR-AC-DFU-101 clinical trial evaluating BioREtain Amnion Chorion allograft versus standard care for non-healing diabetic foot ulcers.
  • The multicenter, randomized controlled trial aims to demonstrate superior wound closure rates over 12 weeks, with topline results expected in Q4 2025.
  • Diabetic foot ulcers affect approximately 15% of diabetic patients and represent a $9-13 billion annual healthcare burden in the United States.
  • The company is simultaneously advancing three clinical trials to validate its proprietary BioREtain processing platform for advanced wound care applications.

Evofem's PHEXXI Hormone-Free Contraceptive Seeks Regulatory Approval in UAE Through Strategic Partnership

  • Pharma 1 Drug Store has submitted PHEXXI for marketing approval to the UAE Ministry of Health and Prevention, marking a key milestone in Evofem's international expansion strategy.
  • The FDA-approved hormone-free contraceptive gel represents the first locally-acting contraceptive that maintains vaginal pH to prevent sperm viability without systemic hormonal effects.
  • Commercial launch is targeted for Q1 2026 in the UAE, with Pharma 1 holding exclusive rights across multiple Middle Eastern markets including Kuwait, Saudi Arabia, and Qatar.
  • Market research indicates growing demand for hormone-free, on-demand contraception in the UAE and surrounding region, positioning PHEXXI to address unmet needs in women's reproductive health.

Oxford BioMedica Achieves Full Ownership of US Subsidiary to Strengthen Global Gene Therapy Manufacturing Network

  • Oxford BioMedica completed acquisition of the remaining 10% stake in its US subsidiary from Q32 Bio, achieving 100% ownership of the Bedford, Massachusetts facility.
  • The 96,000 square foot facility offers both lentiviral and AAV vector manufacturing capabilities and has successfully integrated OXB's lentiviral platform in 2024.
  • The acquisition strengthens OXB's position in the expanding viral vector manufacturing market and supports global client access to cell and gene therapy development services.

Laekna's LAE102 Shows Promising Safety Profile in First-in-Human Obesity Trial at ADA 2025

Monoclonal Antibody
  • Laekna presented positive Phase I results for LAE102, an ActRIIA-selective antibody targeting obesity, demonstrating favorable safety profile and prolonged target engagement in healthy volunteers.
  • The first-in-human study enrolled 64 participants and showed no serious adverse events, with LAE102 maintaining 2-to-3-fold increases in Activin A levels for 28 days post-administration.
  • Preclinical studies revealed LAE102 significantly induced muscle growth and reduced fat mass, with synergistic effects when combined with LAE103, positioning it as a potential next-generation weight-loss therapy.
  • The company has established a comprehensive ActRII receptor portfolio and secured clinical collaboration with Eli Lilly to accelerate global development of LAE102 for obesity treatment.

Lexaria Bioscience Reaches 50-Patent Milestone with New Epilepsy and Nicotine Delivery Patents

  • Lexaria Bioscience Corp. has achieved a significant intellectual property milestone by reaching 50 patents worldwide, including two new international patents for epilepsy treatment and nicotine delivery applications.
  • The company received a new patent in Australia for its DehydraTECH technology in epilepsy treatment, expanding protection beyond its existing six U.S. patents in this therapeutic area.
  • A new patent was granted in Japan for sublingual nicotine delivery, joining existing patents in the U.S. and Canada within the same patent family.
  • The epilepsy drug market was valued at $9.5 billion in 2023 and is projected to exceed $15 billion by 2032, while the global oral nicotine market was worth $5.5 billion in 2023 with expected 26% annual growth through 2030.

Carisma Therapeutics and OrthoCellix Announce $25M Merger to Advance Phase 3 Knee Cartilage Therapy

  • Carisma Therapeutics and OrthoCellix have entered into a definitive merger agreement to create a Nasdaq-listed regenerative cell therapy company focused on orthopedic diseases.
  • The combined company will advance NeoCart®, an autologous cartilage implant technology that uses patient cells to repair knee articular cartilage defects, into Phase 3 trials by end of 2025.
  • The merger includes $25 million in concurrent financing, with OrthoCellix stockholders expected to own approximately 90% of the combined company upon closing.
  • NeoCart® has received FDA Regenerative Medicine Advanced Therapy designation and utilizes a 3D scaffold platform to grow chondrocytes that produce adolescent-like cartilage.

Cure Rare Disease Advances LGMDR9 Gene Therapy Following Positive FDA Pre-IND Meeting

Rare Disease
  • Cure Rare Disease completed a successful pre-IND meeting with the FDA for CRD-003, a gene therapy targeting Limb-Girdle Muscular Dystrophy type 2I/R9 using a novel AAVMYO2 capsid.
  • The FDA endorsed the company's clinical trial design and biomarker strategy while agreeing that a 4-month murine toxicology study could support first-in-human trials.
  • The agency suggested CRD-003 may be eligible for accelerated approval based on Phase I/II results, marking a significant regulatory milestone for this rare neuromuscular disease treatment.

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