Daily Top News – July 6, 2020

July 6, 2020

daridorexant (ACT-541468) / Idorsia, Mochida
Idorsia announces positive results in the second Phase 3 study of daridorexant (GlobeNewswire) – Jul 6, 2020 – P3, N=924; NCT03575104; Sponsor: Idorsia Pharmaceuticals Ltd.; “Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the second pivotal Phase 3 study investigating 10 and 25 mg doses of its dual orexin receptor antagonist, daridorexant, in 924 adult and elderly patients (39.3% ≥ 65 years) with insomnia….Showed positive effects on daytime functioning, with patients reporting no morning sleepiness and no evidence of rebound or withdrawal symptoms upon treatment discontinuation….Two Phase 3 studies allows for the two groups of 25 mg and placebo to be pooled and a pre-planned analysis to be made….Company is united in the effort to file the NDA with the US FDA around the end of this year and to prepare for a successful launch….Detailed results of the Phase 3 studies will be made available through scientific disclosure at upcoming congresses…”

 

SEP-4199 / Sumitomo Dainippon
Sunovion Announces Topline Results from Global Phase 2 Study of SEP-4199 in Patients with Bipolar I Depression (Businesswire) – Jul 6, 2020 – P2, N=344; NCT03543410; Sponsor: Sunovion; “Sunovion Pharmaceuticals Inc. (Sunovion) today announced topline results from study SEP380-201…for the treatment of major depressive episodes associated with bipolar I disorder (bipolar I depression)….SEP-4199 showed numerical improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo after six weeks of treatment….While the study did not meet its primary endpoint, a relatively large improvement in MADRS total score was observed….’The results of this study will guide us as we consider our plans to start Phase 3 studies.'”

 

vafidemstat (ORY-2001) / Oryzon
ORYZON Presents Final Data From its Phase IIa Clinical Trial REIMAGINE at the 28th European Congress of Psychiatry, EPA 2020 (GlobeNewswire) – Jul 6, 2020 – P2a, N=30; “Oryzon Genomics, S.A….has presented the final data from its Phase IIa clinical trial REIMAGINE….The data presented are the final data of the 30 patients who participated in the study: 12 patients with Borderline Personality Disorder (BPD), 11 with ADHD and 7 with Autism Spectrum Syndrome (ASD)….The efficacy of vafidemstat in the control of agitation and aggression was assessed….The most significant improvements were found in the BPD population….Oryzon plans to submit in the coming weeks a Clinical Trial Application (CTA), the European IND equivalent, to the Spanish Drug Agency (AEMPS) to perform a Phase IIb clinical trial to evaluate vafidemstat for the treatment of agitation and aggressiveness in patients with Borderline Personality Disorder….This trial, named PORTICO, will start in Spain to progressively deploy to other European countries and the USA.”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer (Businesswire) – Jul 6, 2020 – “Daiichi Sankyo Company…today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP)….The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer…”

 

Dayvigo (lemborexant) / Eisai
EISAI TO LAUNCH IN-HOUSE DEVELOPED NEW ANTI-INSOMNIA DRUG DAYVIGO (LEMBOREXANT) WITH INDICATION FOR INSOMNIA IN JAPAN (Eisai Press Release) – Jul 6, 2020 – “Eisai Co., Ltd….announced today that it has launched its in-house-discovered and developed orexin receptor antagonist DAYVIGO® 2.5 mg, 5 mg, 10 mg tablets (lemborexant) for treatment of insomnia in Japan on July 6, 2020. Eisai received marketing and manufacturing approval for this formulation on January 23, 2020, and the product was added to Japan’s National health Insurance drug price list on April 22, 2020….In addition, Eisai submitted a new drug application seeking approval of DAYVIGO in Canada and Australia.”

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