Product Development

Sage to explore brexanolone in treatment-resistant depression trial this summer/fall; PPD data propels decision for late-stage study, investigators say

Sage Therapeutics’ (NASDAQ:SAGE) brexanolone could initiate a late-stage trial in treatment-resistant depression (TRD) as early as this summer or fall, buoyed by strong results from its developments in postpartum depression (PPD), said two investigators on the forthcoming trial.

The trial appears to be a late-stage study (either Phase IIb or III) following discussions with the FDA, which encouraged Sage to proceed directly to this stage following work done in PPD, the first investigator said.

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Intercept’s Ocaliva an increasing enrolment obstacle in ongoing/future second-line PBC clinical trials, yet-to-be approved therapies unlikely for first-line, experts say

Ongoing and future clinical trials in second-line primary biliary cholangitis (PBC) are likely to face Intercept Pharmaceuticals’ (NASDAQ:ICPT) Ocaliva (obeticholic acid) as an increasing enrolment hurdle, four European experts said. Ocaliva’s positive efficacy profile has leading to its establishment as a second-line standard, and competitors are likely to experience enrolment challenges with placebo-controlled trial designs, they said.

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Roche’s 614-patient Phase III Tecentriq/BCG vaccine trial in nonmuscle invasive bladder cancer has five patients so far, opened in December, source says

Roche’s (SIX:ROG) Phase III ALBAN trial investigating Tecentriq (atezolizumab) in combination with BCG vaccine in high-risk, nonmuscle invasive bladder cancer has so far recruited at least five patients after starting enrolling patients in December, a source familiar with the trial said.

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Reata’s bardoxolone Phase II prospects in FSGS obstructed by checkered data in other kidney disorders, experts say

Reata Pharmaceuticals’ (NASDAQ:RETA) Phase II pursuit of bardoxolone in focal segmental glomerulosclerosis (FSGS) may be thwarted given proteinuria increases seen in other kidney disorder trials, said nephrologists.

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Roche’s cobas EGFR liquid biopsy use suffers in light of popular panel tests as NSCLC landscape evolves, experts say

Roche’s (SIX:ROG) cobas EGFR Mutation Test v2 liquid biopsy diagnostic used with and after initial treatment with its own drug Tarceva (erlotinib) is becoming increasingly redundant as more physicians choose AstraZeneca’s (LON:AZN) Tagrisso (osimertinib) for first-line (1L) treatment of EGFR mutant non-small cell lung cancer (NSCLC).

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Tyme’s future Phase III needs to focus on patient subsets due to BCR prostate cancer heterogeneity; early Phase I/II SM-88 data provide limited foresight potential, experts say

Tyme Technologies’ (NASDAQ:TYME) potential Phase III trial investigating SM-88 in biochemically recurrent (BCR) prostate cancer should zero in on niche populations for trial success due to significant heterogeneity between such patients, experts said.

While three experts noted specifically enrolling patients according to prostate-specific antigen (PSA) doubling time—a BCR prostate cancer diagnostic test—could be helpful, one expert said classification according to genomic features can be challenging due to cell differences between tumour cells.

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Spark has submitted updated Phase I/II choroideremia data for ARVO meeting in April; earlier-stage patients show improved albeit nonstatistically significant efficacy, exec says

Spark has submitted updated Phase I/II choroideremia data for ARVO meeting in April; earlier-stage patients show improved albeit nonstatistically significant efficacy, exec says

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Sarepta's golodirsen DMD data elicit lackluster expert interest for accelerated approval; clinical benefits from Phase I/II dystrophin increase expected to be mild

Sarepta Therapeutics’ (NASDAQ:SRPT) Phase I/II SRP-4053 (golodirsen) data is not strong enough for approval in Duchenne’s muscular dystrophy, experts said.

On 20 December, Sarepta announced that it had finished its rolling NDA for accelerated approval of golodirsen in DMD patients who have genetic mutations subject to skipping exon 53. One analyst report noted a likely approval based on the data’s strength; another analyst stated the results show a modest benefit but pointed out there is a lack of treatment options.

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Eli Lilly Verzenio usage split roughly three-ways in HR+ breast cancer, exec says

Eli Lilly’s (NYSE:LLY) Verzenio (abemaciclib) usage within its three labelled indications in hormone receptor-positive (HR+) breast cancer has been approximately 20% as a late-line monotherapy, 30% as an initial therapy in combination with anastrozole, and 40% in combination with AstraZeneca’s (LON:AZN) Faslodex (fulvestrant), said Alex Horn, global development leader for Abemaciclib, Eli Lilly, Indianapolis.

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Arena’s Phase II etrasimod has welcome anti-inflammatory MOA for PBC but may be nonspecific, data in UC inapt for extrapolation, experts say

Although Arena Pharmaceuticals’ (NASDAQ:ARNA) etrasimod has a logical anti-inflammatory mechanism for potential Phase II success in primary biliary cholangitis (PBC), experts also noted the same mechanism may lack specificity to have clear impact on the autoimmune disease.

While there is etrasimod Phase II data in ulcerative colitis (UC), it is unlikely to be areliable gauge for potential efficacy in PBC due to disease differences, even if both have inflammatory disease elements, experts noted.

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