Out of the starting gate

A roundup of clinical trial startups and initial breakthroughs

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Starting off our roundup of news about trial studies either just beginning or going into new phases, we have Germany’s MorphoSys and Belgium-based Galapagos announcing in mid-September a Phase 1 bridging study testing a subcutaneous formulation of MOR106, an investigational antibody directed against IL-17C. MOR106 was generated using MorphoSys’s Ylanthia antibody platform and is based on a target discovered by Galapagos.
This bridging study is a parallel-design Phase 1 clinical trial conducted in two parts. Part 1 is a single center, randomized, open-label study in healthy volunteers who will be treated with different single-dose levels of MOR106, administered subcutaneously or intravenously. Part 2 is a multiple center randomized, placebo-controlled, multiple-dose study in patients with moderate to severe atopic dermatitis who will be treated subcutaneously for 12 weeks. Safety and tolerability, pharmacokinetics and occurrence of anti-drug antibodies after administration of MOR106 will be assessed as endpoints. Efficacy of MOR106 will also be explored in subjects with moderate-to-severe atopic dermatitis.
“This study represents the next important step in our strategy to progress MOR106 rapidly in the clinic and is expected to provide additional insights into patient response, while we await the results of our ongoing IGUANA Phase 2 trial with MOR106 in atopic dermatitis patients,” said Dr. Walid Abi-Saab, chief medical officer of Galapagos.
EyeGate randomizes first patients in punctate epitheliopathies study
WALTHAM, Mass.—EyeGate Pharmaceuticals has randomized the first three patients in its study evaluating the ability of EyeGate’s Ocular Bandage Gel (OBG) to reduce corneal staining—a sign of ocular surface damage—in patients with punctate epitheliopathies (PE) due to pathologies such as dry eye. Randomization occurs if a patient meets specific clinical criteria after a two-week qualification period and can then enter the treatment phase of the study. To date, EyeGate has enrolled 34 subjects in the qualification stage. Enrollment is ongoing, as 30 subjects are required to qualify for the treatment stage.
EyeGate’s other ongoing OBG study, for patients who have large corneal defects due to photorefractive keratectomy surgery, is currently greater than 80 percent enrolled. Consequently, EyeGate expects to be on track for announcing top-line data on both studies in the fourth quarter of 2018. Both studies aim to test the potential of the unique proprietary OBG technology to manage the healing of the corneal epithelium for the benefit of patients experiencing these common conditions, which can cause pain, irritation and reduced vision.
PE are an early sign of epithelial compromise and are associated with a variety of pathologic ocular inflammatory conditions. PE are characterized by a breakdown or damage of the epithelium of the cornea, which will stain positively with fluorescein. The endpoint of treatment is to re-epithelialize the cornea and reduce corneal staining.
Opiant Pharmaceuticals enrolls final patient in OPTN001 Phase 2 clinical trial
SANTA MONICA, Calif.—Opiant Pharmaceuticals has completed patient enrollment in its Phase 2 clinical trial of OPTN001, a naloxone nasal spray, for the treatment of bulimia nervosa. The company expects to report top-line data from this trial in the first quarter of 2019.
“OPNT001 has the potential to address the unique needs of this patient population because it has demonstrated a rapid absorption profile and allows for on-demand dosing by patients when they experience the urge to binge,” said Dr. Susan McElroy, an eating disorders expert at the Lindner Center of HOPE. “This can help to establish a sense of control, which patients with bulimia desperately want, and if bingeing is controlled, patients won’t carry out compensatory behaviors, primarily purging. It may also support medication adherence, because once OPNT001 is administered intranasally, the treatment cannot be purged.”
The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the safety and tolerability of OPNT001 as well as its impact on various clinical outcomes, including changes in eating behavior. The primary endpoint of the study is a reduction in binge-eating days. The study has enrolled 86 patients across 19 clinical sites in the United Kingdom.
Pieris Pharmaceuticals doses first patient in Phase 1 PRS-343 and atezolizumab combination trial
BOSTON—Pieris Pharmaceuticals announced last month the dosing of the first patient in its Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology drug candidate targeting HER2 and 4-1BB, plus atezolizumab (Tecentriq), an approved PD-L1 inhibitor. The trial, a multi-center, open-label, Phase 1 dose-escalation study, is designed to determine the safety, tolerability and potential synergistic anti-tumor effects of PRS-343 plus anti-PD-L1 immunotherapy in patients with advanced or metastatic HER2-positive solid tumors.
“The initiation of the combination trial of PRS-343 with an anti-PD-L1 immunotherapy marks the beginning of Pieris’ investigation into the potential synergistic effects of its 4-1BB-targeted therapy with PD-1/L1 blockade,” commented Dr. Louis Matis, senior vice president and chief development officer of Pieris. “Given evidence from multiple preclinical studies demonstrating synergistic antitumor activity from concurrent 4-1BB activation and PD-(L)1 pathway blockade, we believe that combination therapy with PRS-343 and atezolizumab has the potential to provide significant clinical benefit for patients. We are enthusiastic to be initiating this trial and look forward to reporting our findings from this combination study next year.”
RedHill Biopharma receives allowance of two new RHB-104 patents
TEL-AVIV, Israel & RALEIGH, N.C.—In July, RedHill Biopharma Ltd. received a Notice of Allowance from the United States Patent and Trademark Office and an Intention to Grant from the European Patent Office for two new patents covering RHB-104. The patents are expected to be valid until at least February 5, 2029, once granted.
RHB-104 is an orally administered antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. The development of RHB-104 for Crohn’s disease is based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients.
RedHill is conducting a first Phase 3 study of RHB-104 in Crohn’s disease. The last patient enrolled in the study completed 26 weeks of treatment for primary endpoint evaluation in early May 2018, and top-line results from the study are expected to be announced in the coming weeks. The MAP US study is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of RHB-104 in subjects with moderately to severely active Crohn’s disease (defined as Crohn’s Disease Active Index (CDAI) between 220 and 450). The primary endpoint is disease remission, defined as CDAI value of less than 150 at week 26. The study has enrolled 331 patients across clinical sites in the U.S., Canada, Europe, Australia, New Zealand and Israel.

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