Company Product Description Indication Status
Phase I
Ascletis Pharma Inc., of Hangzhou, China ASC-18 (ravidasvir, sofosbuvir) NS5A inhibitor, nucleotide analog inhibitor Hepatitis C virus infection Bridging study showed pharmacokinetics, safety and tolerability of the drug were comparable to the two drugs given as separate pills
Aquestive Therapeutics Inc., of Warren, N.J. AQST-108 Sublingual epinephrine Healthy volunteers (eventually allergic reactions, including anaphylaxis) Dosed first of up to 28 healthy volunteers in the study comparing the pharmacokinetics and pharmacodynamics of AQST-108 to subcutaneous and intramuscular injections of epinephrine; secondary endpoints include changes in blood pressure and heart rate
Immunic Inc., of New York IMU-856  Small-molecule modulator of an undisclosed target Healthy volunteers and diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn's disease Treated first subject in the study testing single and multiple ascending doses in healthy volunteers to test safety, tolerability and pharmacokinetic properties of IMU-856; part 3 will enroll patients to measure changes in bowel permeability using a 2-sugar test to monitor therapeutic effects
Matinas Biopharma Holdings Inc., of Bedminster, N.J. MAT-2203 Oral formulation of the fungicide amphotericin B HIV-infected patients with cryptococcal meningitis Data published in Antimicrobial Agents and Chemotherapy showed MAT-2203 was well-tolerated when given in 4-6 daily doses without the toxicities commonly seen with intravenous amphotericin B
Phase II
Annovis Bio Inc., of Berwyn, Pa. ANVS-401 Acetylcholinesterase/beta-amyloid synthesis/huntingtin/synuclein alpha/tau protein inhibitor Alzheimer’s disease (AD) and Parkinson’s disease (PD) Restarting enrollment in 24-patient study; 15th AD patient expected to be enrolled at the end of August; data expected in 2021; starting a new study enrolling 14 AD and 14 PD patients with initial data expected in early 2021; study will be followed by a dose response study in 40 PD patients with data expected by late summer 2021
CNS Pharmaceuticals Inc., of Houston Berubicin  Anthracycline that interferes with topoisomerase II  Glioblastoma multiforme Engaged with worldwide clinical trials to run the study
Entera Bio Ltd., of Boston EB-613 Human parathyroid hormone (1-34) Osteoporosis  Interim data from first 50% of patients expected to enroll showed 6 months of treatment with 1.5 mg EB-616 increased lumbar spine bone mineral density (BMD) by 1.44% compared to a 0.71% decrease for placebo (p=0.08); the lower doses of 0.5 mg and 1.0 mg showed a dose dependent increase in lumbar spine BMD
Orgenesis Inc., of Germantown, Md. Ranpirnase   Pancreatic ribonuclease enzyme External genital warts caused by human papilloma virus Entered into a services agreement with Therapeutics Inc. to run the study expected to start in early 2021
Puma Biotechnology Inc., of Los Angeles Neratinib  EGFR antagonist; Erbb2/Erbb4 tyrosine kinase receptor inhibitor Early stage HER2-positive breast cancer In the Control study published in Annals of Oncology, a dose escalation of loperamide and a lower dose of neratinib during the first 2 weeks of a 52-week treatment reduced grade 3 diarrhea rate to 15% of the subjects compared to 40% in the Extenet study; discontinuations were 3% in the Control study vs 17% in Extenet; 3% of Control subjects need to dose reduce compared to 26% of Extenet subjects
Phase III
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Evinacumab  Monoclonal antibody targeting angiopoietin-like 3 Homozygous familial hypercholesterolemia Data published in the New England Journal of Medicine showed evinacumab added to other lipid-lowering therapies reduced low-density lipoprotein cholesterol by 47% compared to a 2% increase for lipid-lowering therapies alone (p<0.0001)
Revive Therapeutics Ltd., of Toronto Bucillamine  Cysteine derivative Mild or moderate COVID-19 FDA approved the expansion of phase III in Asia-Pacific countries and Canada with dosing to start in September
Viiv Healthcare Ltd., of London  Dovato (dolutegravir/lamivudine) Once-daily, single pill combining integrase strand transferase inhibitor and nucleoside analogue reverse transcriptase inhibitor HIV-1 infection  In the Stat study testing rapid test and treat protocol before baseline HBV co-infection status, renal function and resistance test results are available, 92% of the 111 evaluable patients achieved a viral load of <50 c/mL at 24 weeks; data include 5 patients who switched from Dovato to an alternative antiretroviral treatment due to hepatitis B virus co-infection or resistance to lamivudine, all of whom achieved viral load of <50c/mL

Notes

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