Company Product Description Indication Status
Phase I
Ampio Pharmaceuticals Inc., of Englewood, Colo. Ampion  Stem cell antigen-1 inhibitor COVID-19 respiratory distress Patients taking Ampion required less oxygen and showed greater clinical improvement than those receiving the standard of care; the drug improved all-cause mortality; plans to increased number of patients in the study from 40 to 140
Enb Therapeutics Inc., of New York ENB-003 Endothelin ET-B receptor antagonist Solid tumors Completed the third dosing cohort of the phase I portion of the phase I/II study; ENB-003 plus Keytruda (pembrolizumab, Merck & Co. Inc.) produced 1 partial response and 4 patients with stable disease among 9 patients with platinum refractory ovarian cancer
Sichuan Clover Biopharmaceuticals Inc., of Chendgdu, China COVID-19 S-Trimer vaccine COVID-19 spike glycoprotein COVID-19 prophylaxis Data published in The Lancet showed vaccine adjuvanted with CpG 1018 plus alum (Dynavax Technologies Corp.) or pandemic adjuvant system (Glaxosmithkline plc) induced high levels of neutralizing antibodies comparable to or exceeding levels in human convalescent sera
Sifi SpA, of Catania, Italy Polihexanide  Polymer targeting trophozoites and cysts of the protozoan Acanthamoeba Healthy volunteers (eventually Acanthamoeba keratitis) Data published in the British Journal of Ophthalmology showed drug had a good safety and tolerability profile including the 0.08% dose, the highest tested
Sorrento Therapeutics Inc., of San Diego COVI-MSC Human allogeneic adipose-derived mesenchymal stem cells COVID-19-induced acute respiratory distress or acute respiratory distress syndrome In addition to the first 3 patients previously reported, the fourth patient treated in the study was discharged after treatment with COVI-MSC
Spark Therapeutics Inc., of Philadelphia, a unit of Roche Holding AG SPK-3006 Adeno-associated viral-based gene therapy expressing a secretable acid alpha-glucosidase Late-onset Pompe disease Dosed first of 20 patients in the Resolute study testing the safety of the gene therapy
Vaccitech Ltd., of Oxford, U.K. VTP-300 ChAdOx1 nonreplicating viral vector delivering 3 full-length HBV antigens Chronic hepatitis B infection Treated first of 64 patients in the HBV002 study testing VTP-300 both with and without a low-dose anti-PD-1 antibody
Phase II
Concert Pharmaceuticals Inc., of Lexington, Mass. CTP-692 Deuterated form of D-serine, a co-agonist of the NMDA receptor Schizophrenia  Study didn't meet primary endpoint assessing the Positive and Negative Syndrome Scale (PANSS) Total Score at 12 weeks; secondary endpoints also weren't met
Matinas Biopharma Holdings Inc., of Bedminster, N.J. Lypdiso Omega-3 fatty acid-based therapeutic Hypertriglyceridemia In the Enhance-It study, Lypdiso increased EPA by 46% and reduced triglycerides by 39% from baseline relative to Vascepa (icosapent ethyl, Amarin Corp. plc); primary endpoint of change from baseline to end of treatment in triglycerides in the pharmacodynamic population didn't meet statistical significance over Vascepa
Sichuan Clover Biopharmaceuticals Inc., of Chendgdu, China, and  Dynavax Technologies Corp., of Emeryville, Calif. S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum COVID-19 spike glycoprotein plus adjuvant COVID-19 prophylaxis Plans to start a phase II/III study in the first half of 2021; interim analysis could occur in the the middle of 2021
Vicore Pharma Holding AB, of Gothenburg, Sweden C-21 Angiotensin II type 2 receptor agonist COVID-19 with signs of an acute respiratory infection but not requiring mechanical ventilation  In the Attract study, treatment with C-21 reduced the need for supplemental oxygen at day 14 by 90% (p=0.003); 1 of 51 patients treated with C-21 required mechanical ventilation compared to 4 of 55 patients treated with placebo
Phase III
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. Roflumilast cream (ARQ-151) Phosphodiesterase type 4 inhibitor Plaque psoriasis In the DERMIS-1 study, roflumilast cream 0.3% produced an Investigator Global Assessment score of clear or almost clear with at least a 2-grade improvement from baseline in 42.4% of patients compared to a vehicle rate of 6.1% (p<0.0001); in DERMIS-2 an IGA success rate was 37.5% for roflumilast  compared to a vehicle rate of 6.9% (p<0.0001)
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Monoclonal antibody targeting PD-1 Metastatic non-small-cell lung cancer without EGFR or ALK genomic tumor aberrations and with PD-L1 expression In the Keynote-498 study, overall survival was 21.4 months for Keytruda plus Yervoy (ipilimumab, Bristol Myers Squibb Co.) compared to 21.9 months for Keytruda alone (p=0.74); median progression-free survival was 8.2 months for the combination vs. 8.4 months for Keytruda alone (p=0.72)
Novan Inc., of Morrisville, N.C. SB-206 Antiviral gel Molluscum contagiosum Completed enrollment in the B-Simple4 study; top-line results expected before the end of the second quarter of 2021
Zosano Pharma Corp., of Fremont, Calif. Qtrypta Zolmitriptan-coated titanium microneedles Acute migraine Post-hoc retrospective analyses of the Zotrip study showed 74% of patients treated with Qtrypta 3.8 mg who had pain relief at 30 minutes were pain free at 2 hours and 100% of patients who were pain free at 30 minutes were pain free at 2 hours; for placebo 35% of those with pain relief at 30 minutes were pain free at 2 hours and 50% of those who were pain free at 30 minutes were pain free at 2 hours

Notes

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