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Incannex Healthcare Secures $60 Million Financing to Advance Clinical Programs

  • Incannex Healthcare has secured a financing agreement with Arena Investors for up to $60 million to advance its clinical-stage drug candidates.
  • The financing includes $10 million in secured convertible notes and a $50 million equity line of credit with Arena Business Solutions.
  • Incannex will use the funds to support ongoing clinical trials for IHL-42X, PsiGAD, and IHL-675A, and for general corporate purposes.
  • The agreement provides an initial funding tranche of $3.33 million, with options for two additional tranches totaling up to $6.67 million.

UK Study: Lifetime Statin Therapy Proves Cost-Effective for Seniors, Regardless of CVD History

• New modeling study demonstrates that statin therapy significantly improves quality-adjusted survival in adults aged 70 and older, with benefits ranging from 0.24 to 0.7 quality-adjusted life years.
• Analysis reveals statin therapy is highly cost-effective, with incremental costs ranging from £116 to £3,502 per quality-adjusted life year gained for standard therapy compared to no treatment.
• Research shows higher-intensity statin regimens provide additional survival benefits of 0.08 to 0.21 life years, remaining cost-effective across all studied population cohorts.

Roivant Launches Pulmovant with In-Licensed Bayer Drug for Pulmonary Hypertension

  • Roivant Sciences has launched Pulmovant, a new venture focused on developing mosliciguat for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • Mosliciguat, an inhaled soluble guanylate cyclase (sGC) activator, was in-licensed from Bayer for $14 million upfront, with potential milestones reaching $280 million.
  • Phase Ib ATMOS study data showed clinically meaningful reductions in pulmonary vascular resistance (PVR) with mosliciguat, suggesting potential for efficacy, safety, and convenient administration.
  • Pulmovant plans to initiate the Phase II PHocus trial imminently, with initial data expected in the second half of 2026, targeting the approximately 200,000 PH-ILD patients in the U.S. and Europe.

Iterum Therapeutics' Sulopenem Poised for FDA Approval for uUTIs, Analyst Predicts

  • H.C. Wainwright analyst Ed Arce maintains a Buy rating for Iterum Therapeutics, citing the potential FDA approval of sulopenem for uncomplicated urinary tract infections (uUTIs).
  • Sulopenem addresses an unmet need in treating uUTIs, particularly infections resistant to other oral antibiotics, despite concerns about antimicrobial resistance (AMR).
  • The FDA advisory panel suggests a restrictive label for sulopenem to minimize off-label use and mitigate AMR risks, potentially impacting Iterum's market position.
  • Approval could position sulopenem as a first-line oral treatment for patients with infections caused by extended-spectrum beta-lactamase (ESBL) producing organisms.

OncoHost's PROphet Platform Shows Promise in Predicting Outcomes for Renal Cell Carcinoma

  • OncoHost's PROphet platform, initially for NSCLC, shows potential in renal cell carcinoma (RCC) for predicting clinical outcomes, according to a study presented at ESMO 2024.
  • The study of 201 RCC patients found that PROphet-POSITIVE patients had significantly improved overall survival (OS) and progression-free survival (PFS) compared to PROphet-NEGATIVE patients.
  • The research identified distinct circulating proteins linked to clinical benefit across different therapies, suggesting the platform's proteomic features have broad predictive value.
  • OncoHost aims to further develop an RCC-specific model to guide patient treatment, expanding the clinical applications of their technology.

Verona Pharma's Ensifentrine (Ohtuvayre) Approved for COPD Maintenance Treatment

  • Verona Pharma's Ensifentrine, marketed as Ohtuvayre, received FDA approval on June 26th for maintenance treatment of chronic obstructive pulmonary disease (COPD).
  • Ohtuvayre, a first-in-class dual PDE3 and PDE4 inhibitor, combines bronchodilator and anti-inflammatory properties into a single compound.
  • Verona Pharma is also developing Ensifentrine for other respiratory indications, including Non-Cystic Fibrosis Bronchiectasis (NCFBE), with a Phase 2 study initiating this quarter.
  • The initial list price for Ohtuvayre is $2,950 per month, with the company focusing on high-volume prescribing healthcare providers and securing Medicare and insurance coverage.

Travere Therapeutics' Filspari Receives Full FDA Approval for IgAN Treatment, Expanding Patient Access

  • Travere Therapeutics' Filspari gains full FDA approval for IgAN, removing prior UPCR restrictions and broadening treatment access.
  • KDIGO guidelines now recognize Filspari as a foundational IgAN therapy, supporting its role in managing the disease.
  • Analysts project increased market penetration for Filspari, estimating a peak U.S. market share of 13.8% by 2031.
  • Phase 3 PROTECT study data supports Filspari's ability to preserve kidney function, leading to expanded eligible patient population.

Roivant Acquires Mosliciguat from Bayer for Pulmonary Hypertension Treatment

  • Roivant Sciences has acquired mosliciguat, an experimental drug, from Bayer to develop as a treatment for pulmonary hypertension.
  • Mosliciguat targets specific types of pulmonary hypertension, addressing high blood pressure in lung arteries and heart damage.
  • This acquisition expands Roivant's pipeline in pulmonary disease and represents Bayer's strategic divestment of the drug.

Biologics by McKesson Selected as Exclusive Pharmacy for Progeria Drug ZOKINVY

  • Biologics by McKesson has been chosen by Sentynl Therapeutics as the exclusive specialty pharmacy for ZOKINVY in the U.S.
  • ZOKINVY (lonafarnib) is the only FDA-approved treatment option for Hutchinson-Gilford Progeria Syndrome and certain Progeroid Laminopathies.
  • This ultra-rare genetic disease affects approximately one in 18-20 million people in the United States, causing premature aging and mortality in children.
  • Biologics by McKesson will ensure that patients prescribed ZOKINVY receive the necessary support and management to optimize their treatment.

Daewoong Pharmaceutical Receives IND Approval for Microneedle Growth Hormone Patch

  • Daewoong Pharmaceutical has secured IND approval for Phase 1 clinical trials of its dissolvable microneedle patch for human growth hormone administration.
  • The trial will assess the safety and pharmacokinetics of the patch against Daewoong's subcutaneous injection formulation, Caretropin Cartridge.
  • The microneedle patch aims to improve patient compliance and reduce discomfort associated with traditional growth hormone injections, especially in pediatric patients.
  • Daewoong's Clopam technology ensures drug stability and precise delivery, addressing challenges related to moisture-induced degradation in microneedle patches.

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