Clinical Trials

Gilead, Galapagos announce 52-week results of filgotinib in FINCH 1, FINCH 3 studies in rheumatoid arthritis

Gilead Sciences and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid arthritis (RA) are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.

Ionis’ Factor XI anti-thrombotic medicine advances with Bayer following positive clinical results

Ionis Pharmaceuticals, the leader in RNA-targeted therapeutics, announced today that the company has been notified by its partner Bayer about the decision to advance IONIS-FXI-LRx following positive clinical results. IONIS-FXI-LRx is an antisense medicine being developed to treat patients with clotting disorders.

Dermira begins phase 3 programme to assess lebrikizumab in patients with moderate-to-severe atopic dermatitis

Dermira, a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, announced dosing of the first patient in a Phase 3 study evaluating the safety and efficacy of lebrikizumab in adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis, the most common form of eczema.

IDEAYA announces first patient dosing of IDE196 for solid tumors outside of uveal melanoma

IDEAYA Biosciences has dosed its first patient with cutaneous melanoma harboring a GNAQ or GNA11 (GNAQ/11) mutation, a key milestone for evaluating Protein Kinase C (PKC) inhibitor IDE196 in solid tumors outside of metastatic uveal melanoma (MUM) as part of IDEAYA's ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions".

Hoth Therapeutics completes phase 1 of in-life dose escalation study for treating Eczema

Hoth Therapeutics, a biopharmaceutical company focused on unique targeted therapeutics for patients suffering from indications such as atopic dermatitis–also known as eczema–as well as dermatological and chronic wound disorders, announced that they have completed Phase I of their In-Life dose escalation study.

RESTORE-IMI 2 phase 3 study of Merck’s RECARBRIO in HABP/VABP meets primary endpoint

Merck, known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 RECARBRIO (imipenem 500 mg, cilastatin 500 mg, and relebactam 250 mg) RESTORE-IMI 2 trial met its primary endpoint.

Clover Biopharmaceuticals doses first patient in Phase I study of SCB-313 in China for malignant ascites

Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, announced that the first patient was dosed in another Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in China for the treatment of cancer patients with malignant ascites.

Tagrisso is only first-line treatment for EGFR-mutated NSCLC to deliver median overall survival of over three years

AstraZeneca announced overall survival (OS) results from the Phase III FLAURA trial of Tagrisso (osimertinib) in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

GSK’s niraparib meets PFS goal in phase 3 PRIMA trial

GlaxoSmithKline (GSK) said that a phase 3 trial called PRIMA has demonstrated its polymerase (PARP) inhibitor Zejula (niraparib) to have significantly improved progression free survival (PFS) in women with first-line platinum responsive advanced ovarian cancer.