Company Product Description Indication Status
Phase I
Apnimed Inc., of Cambridge, Mass. AD-109 Norepinephrine reuptake inhibitor atomoxetine plus the antimuscarinic R-oxybutynin Healthy volunteers (eventually obstructive sleep apnea) Drug demonstrated a favorable pharmacokinetic profile and was well-tolerated; plans to start a phase II study before the end of 2020
Virometix AG, of Schlieren, Switzerland V-306  Respiratory syncytial virus vaccine RSV prophylaxis All 20 subjects received the first dose of vaccine or placebo and there were no adverse events reported; data safety monitoring board scheduled to meet Oct. 2, 2020; second dose scheduled for the week commencing Nov. 2, 2020
Phase II
Epygenix Therapeutics Inc., of Paramus, N.J. EPX-100 Antihistamine  Dravet syndrome Started the 20-week study
Intensity Therapeutics Inc., of Westpoint, Conn. INT230-6 Cisplatin and vinblastine plus a penetration enhancer molecule Breast cancer, liver cancer and sarcoma First patient dosed in the cohort of the IT-01 study testing INT230-6 plus Yervoy (ipilimumab, Bristol Myers Squibb Co.)
Principia Biopharma Inc., of South San Francisco Rilzabrutinib BTK inhibitor  IgG4-related disease First of about 25 participants with active disease dosed in phase IIa trial assessing study drug plus glucocorticoids vs. glucocorticoids alone; primary endpoint is proportion who achieve complete remission at week 12 with no glucocorticoid use at week 4 for rilzabrutinib arm and week 12 for glucocorticoids arm; after 12-week treatment period participants may be eligible to enter 40-week extension followed by 4-week safety follow-up
Rhovac AB, of Stockholm RV-001 RhoC GTPase modulator Prostate cancer First participant in Sweden enrolled in phase IIb Bravac trial expected to recruit more than 175 people to assess effectiveness of study drug to prevent or limit advanced disease after curative intent therapy
Rigel Pharmaceuticals Inc., of South San Francisco Tavalisse (fostamatinib) Spleen tyrosine kinase inhibitor COVID-19 infection Study sponsored by NIH's NHLBI in collaboration with Inova Health System initiated and expected to enroll about 60 hospitalized patients rated 5 to 7 on 8-point ordinal scale of respiratory measures to assess early efficacy and clinically relevant measures of disease progression vs. placebo
Phase III
Mimedx Group Inc., of Marietta, Ga. Micronized dehydrated human amnion chorion membrane Injectable wound care product Plantar fasciitis  Concluded enrollment in study 
Novartis AG, of Basel, Switzerland Tafinlar (dabrafenib) + Mekinist (trametinib) Raf B kinase inhibitor + dual MEK-1/2 kinase inhibitor Melanoma 5-year Combi-AD data, published in The New England Journal of Medicine, showed 52% in treatment arm remained alive and relapse-free vs. 36% for placebo; median relapse-free survival was not reached in treatment arm vs. 16.6 months for placebo
Octapharma AG, of Lachen, Switzerland Panzyga Human immunoglobulin (10% solution) Secondary immunodeficiency Recruitment initiated in PRO-SID study evaluating therapy as primary prophylaxis for infection control in at least 240 adults with chronic lymphocytic leukemia; primary outcome is occurrence of at least 1 major infection over 52 weeks vs. placebo, with both groups also receiving standard-of-care infection prophylaxis

Notes

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

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