Company Product Description Indication Status
Phase I
Arcturus Therapeutics Holdings Inc., of San Diego  ARCT-810 Messenger RNA-based therapeutic Ornithine transcarbamylase deficiency Dosed first healthy volunteer; study will evaluate 5 cohorts, each with 6 subjects
Magenta Therapeutics Inc., of Cambridge, Mass.    MGTA-145 Stem cell mobilization therapy Autoimmune diseases Data showed combination with plerixafor reliably mobilized sufficient stem cells (median: 4.3 million CD34+ cells/kg) for transplant in a single day; MGTA-145 was safe and well-tolerated in 79 subjects as a single agent and in combination with plerixafor
Nektar Therapeutics Inc., of San Francisco NKTR-358 T regulatory cell stimulator Systemic lupus erythematosus Results from phase Ib study show NKTR-358 was safe and well-tolerated in patients with mild to moderate SLE and led to marked and selective, dose-dependent expansion of regulatory T cells that was maintained over multiple administrations
Phase II
Lysogene SA, of Paris LYS-SAF302 Gene therapy Mucopolysaccharidosis type IIIA Trial placed on clinical hold
PDS Biotechnology Corp., of Florham, N.J. PDS-0101 Versamune immunotherapy product Locally advanced cervical cancer Trial to begin
Tetra Bio-Pharma Inc., of Ottawa Qixleef Cannabinoid-derived drug Chronic pain Trial resumes
Phase III
Aurinia Pharmaceuticals Inc., Victoria, British Columbia Voclosporin  Calcineurin inhibitor Lupus nephritis Renal response rate was 40.8% for voclosporin and 22.5% for the control (p<0.001); drug met all secondary endpoints, including renal response at 24 weeks, partial renal response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UCPR) ≤ 0.5 and time to 50% reduction in UPCR; response rates favoring voclosporin were seen across age, sex, race, biopsy class, region and prior mycophenolate mofetil use subgroups
Avenue Therapeutics Inc., of New York, I.V. tramadol  Opioid receptor mu agonist Pain associated with abdominoplasty surgery Data published in Drugs in R&D showed I.V. tramadol was statistically superior to placebo and comparable to I.V. morphine for the primary and all key secondary efficacy outcomes
Novartis AG, of Basel, Switzerland, and Sosei Group Corp., of Tokyo Enerzair Breezhaler Fixed dose combination of indacaterol, glycopyrronium and mometasone furoate Asthma Data from the Argon published in Respiratory Medicine showed Enerzair Breezhaler was noninferior to a free combination of twice-daily, high-dose salmeterol xinafoate/fluticasone propionate plus once-daily tiotropium in change from baseline in Asthma Quality of Life Questionnaire

Notes

For more information about individual companies and/or products, see Cortellis.

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