Realm Therapeutics announced that the Company has completed enrollment in its Phase II study of PR022, Realm’s first-in-class topical IL-4 / IL-13 inhibitor, for the treatment of Atopic Dermatitis. The trial is being conducted in the U.S. The Phase II study is a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study assessing the safety and efficacy of multiple doses of PR022 in 122 adult patients with mild-to-moderate Atopic Dermatitis. Multiple endpoints are being explored, including Eczema Area and Severity Index (EASI), an investigator-assessed tool used to measure the extent (area) and severity of atopic eczema; Investigator Global Assessment (IGA), an investigator-assessed instrument measuring severity of Atopic Dermatitis on a 5 grade scale; as well as additional assessments of pruritus and quality of life. In pre-clinical models of Atopic Dermatitis, PR022 has shown immunomodulatory effects, without the same immunosuppressive side effects often associated with steroids, which are the current standard of care.
Genentech announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). The co-primary endpoints were PFS as determined by the investigator using RECIST v1.1 in all randomized people without an EGFR or ALK mutation (intention-to-treat wild-type; ITT-WT) and OS in the ITT-WT population. The combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and ABRAXANE [albumin-bound paclitaxel; nab-paclitaxel]) helped people live significantly longer compared to chemotherapy alone in the initial treatment of advanced non-squamous non-small cell lung cancer (NSCLC). IMpower130 is a Phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with Stage IV non-squamous NSCLC. The study enrolled 724 people who were randomized equally (1:1) to receive TECENTRIQ plus carboplatin and nab-paclitaxel (Arm A), or Carboplatin and nab-paclitaxel (Arm B, control arm). During the treatment-induction phase, people in Arm A received TECENTRIQ and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People received TECENTRIQ during the maintenance treatment phase until loss of clinical benefit was observed. During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People who were consented prior to a protocol revision were given the option to crossover to receive TECENTRIQ as monotherapy until disease progression.
Atox Bio announced that the first patient has been enrolled in the Phase II REAKT (Reltecimod E fficacy for Acute Kidney Injury T rial) study. The Phase II randomized, placebo-controlled study, will enroll 120 patients with abdominal sepsis and Stage 2/3 Acute Kidney Injury (AKI) (as described by KDIGO criteria) at approximately 50 level 1 trauma centers in the U.S. Patients will receive Reltecimod or placebo, administered as a single dose within 6 hours of the diagnosis of AKI, in addition to standard of care treatment. Reltecimod (AB103) is a rationally designed peptide that binds to the CD28 co-stimulatory receptor and restores the host’s appropriate immune response to severe infections. By modulating, but not inhibiting, the body’s acute inflammatory response, Reltecimod is designed to help control the cytokine storm that could otherwise quickly lead to morbidity and mortality. The primary endpoint is complete recovery from Stage 2/3 AKI, defined as alive, free of dialysis and return of serum creatinine to <150 percent of reference baseline. The primary end point is a clinical composite that evaluates both the local and systemic components of this disease. Important secondary endpoints include survival, resolution of organ dysfunction and other health economic outcomes such as days on the ventilator, days in the ICU, duration of hospital stay and need for hospital readmission.
Novo Nordisk announced the headline results from PIONEER 2, the second Phase IIIa trial with oral semaglutide for treatment of adults with type 2 diabetes. Oral semaglutide is a new GLP-1 analogue taken once daily as a tablet. PIONEER 2 was a 52-week, randomized, open-label, active-controlled, parallel-group, multicentre, multinational trial with two arms comparing the efficacy and safety of oral semaglutide with empagliflozin in people with type 2 diabetes mellitus, inadequately controlled on metformin. 816 people were enrolled in PIONEER 2 and randomized 1:1 to receive either 14 mg oral semaglutide or 25 mg empagliflozin once daily. The confirmatory endpoints were change in HbA1c and body weight from baseline to week 26. Key secondary endpoints included change in HbA1c and body weight from baseline to week 52. The most common adverse event for oral semaglutide was mild to moderate nausea, which diminished over time. The proportion of subjects who discontinued treatment due to adverse events was 11 percent for people treated with 14 mg oral semaglutide compared to 4 percent for people treated with 25 mg empagliflozin.