Concert Pharmaceuticals announced that it will include an additional cohort of patients in the Phase 2a trial evaluating CTP-543. The protocol amendment provides for additional patients to be enrolled in the trial in order to evaluate a 12 mg dose of CTP-543 or placebo twice daily for 24 weeks. In 3Q18, an independent Data Monitoring Committee conducted a planned interim safety data review after patients in the trial had been dosed with an 8 mg dose of CTP-543 or placebo twice daily for at least 12 weeks. Based on this review, the DMC provided its recommendation to continue with the current 8 mg cohort to completion and also provided support for an additional cohort to evaluate the 12 mg dose twice daily. The company has initiated enrollment in the 12 mg cohort. The company also expects to report topline data from the 4 mg and 8 mg cohorts of the Phase 2a trial in 4Q18. The Phase 2a trial is a double-blind, randomized, placebo-controlled, sequential dose trial to evaluate the safety and efficacy of CTP-543 in adult patients with moderate-to-severe alopecia areata. With the protocol amendment, patients are randomized to receive one of three doses of CTP-543 or placebo twice daily. Enrollment in the 4 mg and 8 mg cohorts is complete and enrollment in the 12 mg cohort is ongoing. The primary outcome measure will utilize the severity of alopecia tool after 24 weeks of dosing.
Wednesday, September 26, 2018
Evofem initiated at Cantor Fitzgerald
Evofem initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst William Tanner started Evofem Biosciences with an Overweight rating and $9 price target. The analyst believes the company’s multi-purpose vaginal pH regulator technology will aid in the creation of novel products for women.
Cantor says concerns over Amarin IP ‘making a mountain out of a molehill’
After speaking with the company and reviewing the public record of its patents and abbreviated new drug application-related matter, Cantor Fitzgerald analyst Louise Chen believes concerns over Amarin’s intellectual property are “making a mountain out of a molehill.” Vascepa’s intellectual property will keep out generics until August 2029, Chen tells investors in a research note. She sees peak sales potential of “billions of dollars” and reiterates an Overweight rating on Amarin with a $15 price target.
Allergan says FDA accepts sNDA for depression med
Allergan announced that the U.S. FDA has accepted for review the company’s supplemental New Drug Application for VRAYLAR, seeking to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder in adults in the current product label. The sNDA is supported by data from three pivotal trials, including RGH-MD-53, RGH-MD-54 and RGH-MD-56. In all three pivotal studies, cariprazine demonstrated greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale total score. Both cariprazine 1.5 mg and 3 mg demonstrated superiority to placebo in reducing depressive symptoms associated with bipolar I depression.
Aldeyra to host conference call
Conference call to discuss results from phase 2b Dry Eye Disease Clinical Trial will be held on September 26 at 8 am. Webcast: http://ir.aldeyra.com/
RA Pharmaceuticals announces results from Phase 1b study of renal med
Ra Pharmaceuticals announced positive results from the Company’s Phase 1b pharmacokinetic study evaluating zilucoplan in patients with renal impairment. The Company has received International Nonproprietary Names clearance for use of the name zilucoplan from the World Health Organization. The Phase 1b, multi-center, open-label trial was designed to evaluate the PK profile of zilucoplan in patients with severe renal impairment as a lead-in to studying zilucoplan in complement-mediated renal disorders. The trial enrolled 16 subjects, including eight patients with severe renal impairment matched with eight healthy control subjects with normal renal function. Each patient received a single, subcutaneous dose of 0.3 mg/kg of zilucoplan. The PK profile of zilucoplan was consistent across both groups, with exposures similar in renally-impaired patients and healthy volunteers. There were no adverse events reported. Overall, the data indicate that zilucoplan can be used in clinical studies of patients with renal impairment without any need for dose adjustment. Zilucoplan is currently being studied in a Phase 2 study in generalized myasthenia gravis with a top-line data read-out expected around year-end 2018. The Company also recently completed interactions with regulators, including the U.S. Food and Drug Administration, for its global Phase 3 program of zilucoplan for the treatment of paroxysmal nocturnal hemoglobinuria. Based on these interactions, Ra Pharma plans to initiate a global, pivotal, single-arm Phase 3 trial in treatment-naive PNH patients during the first half of 2019.
JMP Securities ‘optimistic’ on Madrigal following Amarin’s Vascepa data
JMP Securities analyst Liisa Bayko said she feels “optimistic” regarding MGL-3196’s potential cardiovascular benefit following Amarin’s (AMRN) announcement that Vascepa reduced the risk of major adverse CV events in the REDUCE-IT long-term outcomes study. The REDUCE-IT data lays an argument that Madrigal’s MGL-3196, which has a similar impact on cardiometabolic parameters, may also provide a CV benefit, contends Bayko. She maintains an Outperform rating and $300 price target on Madrigal Pharmaceuticals shares.
https://thefly.com/landingPageNews.php?id=2795673
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