Company Product Description Indication Status
Phase I
Abeona Therapeutics Inc. of New York EB-101 Autologous gene-corrected cell therapy Recessive dystrophic epidermolysis bullosa Detailed analysis from phase I/IIa trial showed wound healing following treatment was associated with improved long-term pain relief
Ziopharm Oncology Inc., of Boston CD19-specific CAR T cells Cell therapy Leukemias and lymphomas Initiated study to enroll up to 24 patients with advanced CD19+ disease who have relapsed after allogeneic bone marrow transplant
Phase II
Center Laboratories Inc., of Taipei, Taiwan C-S02 Small molecule Diabetes Study met primary endpoint, showing significant decreases of HbA1c in treated patients vs. placebo by 0.45% (p= 0.0098)
Macrogenics Inc., of Rockville, Md. Margetuximab Monoclonal antibody targeting HER2 Gastroesophageal adenocarcinoma The Lancet Oncology published results showing combination with pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive disease previously treated with chemotherapy and trastuzumab resulted in objective response rate of 18% (17/92), including complete responses and partial responses; disease control rate was 53% (49/92); median progression-free survival was 2.7 months and median overall survival was 12.5 months 
Phase III
Atox Bio Inc., of Durham, N.C. Reltecimod Synthetic peptide antagonist of superantigen exotoxins and CD28 T-cell co-stimulatory receptor Severe necrotizing soft tissue infection Analysis of the modified intent-to-treat population from the Accute study showed 48.6% of treated patients achieved clinical success, assessed using the necrotizing infection clinical composite endpoint (NICCE), vs. 39.9% for placebo (p=0.14); in key endpoint of assessment of resolution of organ dysfunction at day 14, assessed by Modified Sequential Organ Failure Assessment, treated patients showed advantage over placebo (65.1% vs. 52.6%, p=0.041); using more clinically relevant patient population in clinically evaluable analysis, 52.6% of Reltecimod patients achieved success on NICCE endpoint vs. 40.3% on placebo (p=0.039), while 70.9% of treated patients achieved resolution of organ dysfunction by day 14 vs. 53.4% on placebo (p=0.005)
DBV Technologies SA, of Montrouge, France Viaskin Peanut Allergy immunotherapy Peanut allergy Results of People study published in The Journal of Allergy and Clinical Immunology showed patients demonstrated durable, long-term clinical benefit with an additional 2 years of treatment, with low discontinuations due to adverse events
Gilead Sciences Inc., of Foster City, Calif. Remdesivir COVID19 non-structural protein 8 modulator/replicase polyprotein 1AB inhibitor; RNA polymerase COVID-19 Comparative analysis of Simple-Severe trial showed remdesivir was associated with improvement in clinical recovery and 62% reduction in the risk of mortality vs. standard of care; subgroup analyses, including evaluation of safety and efficacy across different racial and ethnic patient subgroups treated in the U.S., found that traditionally marginalized racial or ethnic groups treated in the study experienced similar clinical outcomes as the overall study patient population
Sedana Medical AB, of Stockholm Isoconda (isoflurane) General anesthetic  Sedation Top-line results showed pivotal study reached primary endpoint, showing administration with Anaconda is an effective sedation method for ventilator-intensive care patients, which is noninferior to propofol
Sosei Group Corp., of Tokyo, and Novartis AG, of Basel, Switzerland  Enerzair Breezhaler (QMF-149; indacaterol acetate, glycopyrronium bromide and mometasone furoate) Long acting beta2 agonist/long-acting muscarinic antagonist/inhaled corticosteroid Asthma The Lancet Respiratory Medicine published data from Iridium study showing once-daily treatment with high- and medium-dose resulted in statistically significant improvements in lung function vs. once-daily QMF-149 in patients whose asthma is uncontrolled with LABA/ICS treatment
Tonix Pharmaceuticals Holding Corp., of New York TNX-102 SL (cyclobenzaprine HCl sublingual tablets) Non-opioid, centrally acting analgesic Fibromyalgia Met target enrollment of about 470 patients in Relief trial ahead of schedule; optional interim analysis expected in September 2020 of first 50% of randomized patients evaluable for efficacy; top-line data expected in fourth quarter of 2020

Notes

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