Equillium, 9 Meters Biopharma and ABVC Biopharma have something to say about lupus, short bowel syndrome and ADHD.
Equillium, 9 Meters Biopharma and ABVC Biopharma have something to say about lupus, short bowel syndrome and ADHD.
For that and more, keep reading.
Equillium Sees “Clinically Meaningful Responses” in Lupus Study
Equillium announced positive interim results Tuesday from the EQUALISE study assessing itolizumab in patients with lupus nephritis.
In EQUALISE Part B, itolizumab demonstrated a “clinically meaningful response” in highly proteinuric subjects, the company reported.
Five of six study participants achieved either a complete or partial response to the drug while four of six had a reduction had a greater than 80% reduction in urine protein creatinine ratio by week 28. Another eight of 12 patients enjoyed a greater than 50% reduction in UPCR, Equillium stated. Another six patients are still being dosed.
Itolizumab is a first-in-class anti-CD6 monoclonal antibody selectively targeting the CD6-ALCAM pathway.
The company is “very encouraged” by the “compelling responses in a patient population with significantly greater baseline proteinuria than recent studies, with a mean baseline UPCR of 5.8 grams,” said Bruce Steel, chief executive officer at Equillium.
The study continues to enroll and Steel anticipates sharing topline data in mid-2023.
9 Meters Extends Positive Update in Short Bowel Syndrome
9 Meters Biopharma reported final data Monday showing a Phase II study of vurolenatide in short bowel syndrome met the primary endpoint.
The VIBRANT study consisted of 11 patients across four randomized arms, with three patients in each vurolenatide arm and two patients in the placebo arm.
Dosing 50 mg vurolenatide every two weeks led to a 30% reduction in total stool output over six weeks compared with a 32% increase for patients on placebo for a mean reduction of 62%, the company reported.
9 Meters noted vurolenatide was generally well tolerated, with mild to moderate and transient side effects.
Based on a meeting held at the end of Phase II, 9 Meters will submit protocol for a Phase III study incorporating the 50 mg Q2W dosing regimen, according to a company statement.
ABVC Shares Update On Phase II ADHD Drug Trial
ABVC Biopharma‘s latest update on the ongoing enrollment for its Phase II clinical trial of ABV-1505 for adults diagnosed with attention-deficit hyperactivity disorder (ADHD) showed that researchers have already screened 43 subjects and enrolled 30 since the first patient was treated on May 10 in Taiwan.
Eighteen of the 30 enrolled subjects have already finished the eight-week treatment. The goal is to enroll around 100 total patients in Taiwan and the U.S.
In addition to this progress, the University of California, San Francisco Medical Center Institutional Review Board stated it plans to participate in this project, which is set to begin in the fourth quarter.
Part 1, which focused on ABV-1505’s active ingredient PDC-1421, was conducted at UCSF from Jan. 2020 to July 2020. It gained the U.S. FDA’s go-ahead by Oct. of the same year after meeting primary endpoints and demonstrating that PDC-1421 is safe, efficacious and well-tolerated. These results prompted the advancement of the study to test ABV-1505 for ADHD.
If outcomes continue to go favorably for the drug, ABVC stated Part 2 is expected to be complete by the third quarter of 2023.
Favorable Response Noted In Innate Phase II Trial On MF Therapy
Interim results from Innate Pharma’s ongoing Phase II TELLOMAK trial studying lacutamab in adults with mycosis fungoides who express KIR3DL2 demonstrated the candidate drug’s ability to provide benefit to patients.
The details, which were shared recently at the EORTC CLTG annual meeting in Spain, showed that lacutamab, a first-in-class anti-KIR3DL2 antibody, produced a global objective response rate of 28.6% in MF patients with the target, including four partial and two complete responses.
The March 4 data cutoff also demonstrated a favorable safety profile for the proposed drug. The TELLOMAK Phase II study is being conducted in the U.S. and Europe.
Innate Pharma plans to announce final data for both MF and Sézary syndrome in 2023, as well as advance two more clinical studies on lacutamab for peripheral T cell lymphoma.
AEON Phase II Trial On Cervical Dystonia Drug Delivers Positive Topline Data
AEON Biopharma announced positive topline results from its Phase II clinical study of ABP-450 for adults with cervical dystonia. The randomized, placebo-controlled trial looked at 57 patients across 20 study locations in the U.S., where participants were divided into three dose cohorts and a placebo group.
Participants were evaluated for the primary safety endpoint at four weeks from dosing, while the follow-up was conducted around 20 weeks after. All three doses of 150, 250 and 350 ABP-450 units demonstrated safety and appeared to be well tolerated. All treatment-related adverse effects were either mild or moderate and transient.
At the end of the Phase II study, patients were given the option to extend into a 52-week open-label trial; 51 of the 57 agreed to continue.
AEON licenses ABP-450 from Daewoong Pharmaceutical, which granted it exclusive development and distribution rights in the U.S., the EU and Canada, among other international territories.
TILT Signs Deal With MSD For Keytruda Combo
TILT Biotherapeutics signed a collaboration and supply deal with Merck subsidiary MSD to start a new clinical trial on TILT-123 combined with Keytruda (pembrolizumab) for patients with immune checkpoint inhibitor refractory non-small cell lung cancer.
This study builds on emerging data on TILT-123, which has shown positive intravenous usability in other indications, including melanoma, ovarian cancer and head and neck cancer.
TILT-123 is a 5/3 chimeric serotype adenovirus with two human cytokines: IL-2 and TNF alpha. It has shown a 100% response rate during in vivo pre-clinical cancer models. In addition to this deal, TILT Bio has another agreement with MSD to use the candidate drug with Keytruda in ovarian cancer.
Anebulo Announces Promising Interim Data From Proposed ACI Therapy
Anebulo Pharmaceuticals shared positive interim results from the first two cohorts of Part B of the ongoing Phase II study on ANEB-001 for acute cannabinoid intoxication (ACI). The two cohorts were given 21 mg of THC orally and then divided into those who received 30 mg of ANEB-001, 10 mg of the same or a placebo.
Participants who received any of the two drug dosages were seen to have significant and sustained reductions in “high” feelings, as measured by the visual analog scale feeling high score. They also saw improvements in VAS alertness and reduced THC-induced body sway compared to those who took a placebo.
Currently, there is no FDA-approved therapy for ACI, and treatment typically requires lengthy emergency room intervention and costly follow-up sessions.
Given the positive results from the first two cohorts, Anebulo researchers are empowered to continue and enroll at least six cohorts in Part B, with up to 15 participants each.
The company is also continuing Part B of the trial at the Center for Human Drug Research in the Netherlands to further study dose-response and the effects of separating ANEB-001 and THC doses. It is also collaborating with the Model-Informed Drug Development group at the FDA to create a PK/PD model that will predict optimal doses for ACI patients.
