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Clinical Trial News

Rebel Medicine Secures $6M Series A Funding and FDA IND Clearance for Non-Opioid Pain Therapy Alevatrix

  • Rebel Medicine closed a $6 million Series A financing round led by Crocker Ventures to advance its non-opioid pain therapeutic development programs.
  • The company received FDA IND clearance for Alevatrix, a novel long-acting bupivacaine formulation designed to provide up to 72 hours of pain relief after surgery.
  • Funding will support a first-in-human Phase 2 clinical trial in bunionectomy patients to evaluate Alevatrix's safety and efficacy as an opioid-sparing therapy.
  • Preclinical studies demonstrated that Alevatrix provides prolonged, multi-day non-opioid analgesia with a favorable safety profile for post-operative pain management.

BullFrog AI Partners with Sygnature Discovery to Expand AI-Driven Drug Discovery Platform Access

AIDrug Discovery
  • BullFrog AI announced a strategic collaboration with UK-based CRO Sygnature Discovery to introduce its AI-driven BullFrog Data Networks™ platform to global biopharma clients.
  • The partnership is expected to generate $15-30 million in revenue for BullFrog AI through 2028 while accelerating brand recognition and user adoption.
  • BullFrog Data Networks™ supports critical drug discovery applications including target identification, mechanism-of-action studies, patient stratification, and clinical trial optimization.
  • The collaboration specifically targets small to mid-sized biopharma companies, a segment often underserved by existing bioinformatics solutions.

Predictive Oncology Develops Exclusive 3D Liver Toxicity Models for Labcorp to Accelerate Drug Discovery

  • Predictive Oncology has successfully developed two distinct 3D liver toxicity models exclusively for Labcorp, including human and rat models that represent the liver microenvironment for drug metabolism and toxicity evaluation.
  • The functional organoid models enable prediction of in vivo drug clearance, drug transport, and hepatotoxicity while providing species-specific data based on physiologic hepatic microenvironments.
  • These models complement Predictive Oncology's AI-driven platform PEDAL, which predicts tumor response to drug compounds with 92% accuracy using a biobank of over 150,000 human tumor samples.
  • Labcorp plans to expand this work into other species to support wider preclinical analyses and translate between animal and human models for new alternative approaches in drug development.

AlzeCure Receives FDA Support for ACD440 Development in Rare Pain Disorder Erythromelalgia

Orphan DrugRare Disease
  • AlzeCure Pharma received positive FDA guidance for advancing ACD440, a first-in-class TRPV1 antagonist, into Phase II/III studies for treating erythromelalgia, a rare chronic pain disorder affecting 1-4 per 100,000 people.
  • The FDA confirmed significant medical need for erythromelalgia treatment, which currently has no approved therapies and causes intense burning pain and severe skin redness in extremities.
  • ACD440 is being developed as a topical gel that maintains low systemic exposure while achieving high local concentrations for maximum analgesic effect, with potential for orphan drug designation and accelerated market access.
  • The drug candidate previously completed positive Phase IIa trials in chronic peripheral neuropathic pain and is based on Nobel Prize-winning scientific research from 2021.

FDA Grants Fast Track Designation to Sumitomo's Nuvisertib for Myelofibrosis Treatment

Orphan DrugRare Disease
  • The FDA has granted Fast Track Designation to nuvisertib (TP-3654), Sumitomo Pharma America's investigational PIM1 kinase inhibitor, for treating intermediate or high-risk myelofibrosis patients.
  • Updated Phase 1/2 data presented at EHA 2025 showed nuvisertib achieved 22.2% spleen volume reduction and 44.4% symptom score improvement in evaluable patients with relapsed/refractory myelofibrosis.
  • The oral selective inhibitor demonstrated significant cytokine modulation with p<0.001 correlation between anti-inflammatory effects and clinical responses, supporting its potential as monotherapy or combination treatment.
  • Myelofibrosis affects 1 in 500,000 people worldwide and represents a serious unmet medical need with limited treatment options for patients facing poor prognosis.

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

NCT04176198RecruitingPhase 1
Sumitomo Pharma America, Inc.
Posted 12/16/2019

Syensqo Opens World's Largest Microbiology Lab in France to Accelerate Biodegradable Product Development

  • Syensqo has inaugurated its largest global microbiology laboratory in Lyon, France, featuring 550 m² of advanced testing capabilities for biodegradation and eco-toxicology studies.
  • The facility will increase biodegradation testing capacity by tenfold compared to 2021 levels, supporting development of environmentally-friendly products across beauty care, home care, and agrochemical markets.
  • The laboratory targets Good Laboratory Practices accreditation in the second half of the year and will offer testing services to external customers and partners.
  • Construction incorporated sustainability measures resulting in 35% decreased net power consumption and 36% reduction in CO2 emissions compared to standard facilities.

AIM ImmunoTech Secures Manufacturing Patent for Ampligen Through 2041

  • AIM ImmunoTech received U.S. patent No. 12312376 covering manufacturing methods for therapeutic double-stranded RNA products including Ampligen, extending protection until January 25, 2041.
  • The patent strengthens AIM's intellectual property portfolio for its first-in-class TLR3 agonist immunomodulator, which has demonstrated broad spectrum activity in clinical trials for cancers, viral diseases, and immune disorders.
  • Combined with existing patents and multiple FDA and EMA orphan drug designations, the manufacturing patent provides AIM extended development runway as it seeks regulatory approval for Ampligen across various indications.

ScreenIn3D Secures £750,000 to Accelerate Cancer Drug Development with Lab-on-a-Chip Technology

  • ScreenIn3D, a University of Strathclyde spin-out, has raised £750,000 in seed funding led by TRICAPITAL Angels to advance its groundbreaking lab-on-a-chip system for cancer drug testing.
  • The technology enables drug developers to test dozens of cancer therapies on tiny patient-derived tumor samples, offering a faster and more accurate alternative to animal testing.
  • The platform dramatically increases the number of drug tests possible on precious human tissue samples, potentially reducing clinical trial failures and accelerating time to market for new therapies.
  • The company plans to expand beyond cancer into women's health, immune therapies, and fertility treatment while growing its workforce from five to eight employees.

Amneal Secures FDA Approval for Generic Prednisolone Acetate Eye Drops, Targeting $201 Million Market

Drug Approval
  • Amneal Pharmaceuticals received FDA approval for prednisolone acetate ophthalmic suspension 1%, a generic version of Allergan's Pred Forte for treating steroid-responsive ocular inflammation.
  • The complex generic product will launch in Q3 2025, entering a market with approximately $201 million in annual U.S. sales according to IQVIA data.
  • The approval represents a key milestone for Amneal's Affordable Medicines segment, demonstrating the company's R&D capabilities in developing complex ophthalmic formulations.
  • Common adverse reactions include elevated intraocular pressure with potential glaucoma development, optic nerve damage, cataract formation, and delayed wound healing.

Nanoform Initiates Pivotal Bioequivalence Studies for Nanoenzalutamide Prostate Cancer Treatment

  • Nanoform Finland has commenced pivotal bioequivalence studies of Nanoenzalutamide, a nanocrystalline-enabled formulation designed as an alternative to XTANDI for prostate cancer treatment.
  • The studies aim to demonstrate bioequivalence between a single 160 mg nanoformed tablet and four 40 mg XTANDI tablets, potentially reducing pill burden for patients.
  • The company has signed its first license and supply agreement for Germany, with additional agreements expected for key markets including the US, Japan, and France.
  • The project represents significant commercial potential with over EUR 35 million in combined development and commercial milestones plus profit sharing opportunities.

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