Human Trials

ViiV begins implementation science study for HIV treatment regimen candidate in Europe

ViiV Healthcare announced the start of the CARISEL study (Cabotegravir And Rilpivirine Implementation Study in European Locations), which aims to evaluate the best approaches to implementing an investigational, every-two-month, injectable HIV treatment regimen into clinical practice in Europe.

Inovio announces partial hold on Covid-19 vaccine candidate trial over FDA queries

Inovio has announced the partial hold on its planned phase 2/3 trial of its Covid-19 vaccine candidate INO-4800 due to additional queries from the US Food and Drug Administration (FDA).

Arena doses first subject in ELEVATE UC 12 phase 3 trial of Etrasimod in ulcerative colitis

Arena Pharmaceuticals announced that the first subject has been dosed in the ELEVATE UC 12 global Phase 3 trial evaluating etrasimod, an investigational, next-generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator, for the potential treatment of moderately to severely active ulcerative colitis.

Millendo Therapeutics initiates first-in-human clinical trial of MLE-301

Millendo Therapeutics announced dosing of the first subject in a Phase 1 clinical trial evaluating the safety, pharmacokinetics and preliminary efficacy of MLE-301, a selective neurokinin 3 receptor (NK3R) antagonist that is being developed for the treatment of VMS, commonly known as hot flashes and night sweats, in menopausal women.

OncoImmune’s SACCOVID demonstrates significant therapeutic efficacy in Covid-19 trial

OncoImmune announced that its investigational immunomodulator SACCOVID (CD24Fc) has demonstrated significant therapeutic efficacy in the phase III SAC-COVID clinical trial.

J&J begins phase 3 trial of Covid-19 vaccine candidate JNJ-78436735

Johnson & Johnson (J&J) has started a phase 3 trial for the JNJ-78436735 (Ad26.COV2.S) vaccine candidate developed by Janssen Pharmaceutical Companies against the prevention of Covid-19.

Micreos initiates clinical trial to evaluate endolysin-drug in atopic dermatitis

Dutch biotech company Micreos Human Health has enrolled the first patients in a Phase I/IIa, randomized, double-blind, placebo-controlled, parallel treated dose-ranging study to assess the safety and efficacy of XZ.700 in patients with mild to moderate atopic dermatitis.

Sinovac begins Covid-19 vaccine candidate trials in Turkey

Chinese biopharmaceutical company Sinovac Biotech has begun phase III clinical trials for its inactivated Covid-19 vaccine candidate in Turkey.

Merck’s Keytruda plus chemotherapy meets OS and PFS goals in KEYNOTE-590 trial

Merck announced first-time data from the pivotal Phase 3 KEYNOTE-590 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer.