Product Development

Gilead’s filgotinib may pass Phase III risk-benefit bar in RA with JAK-1 target despite safety caution; efficacy has more assurances, experts say

(NASDAQ:GILD) GLPG0634 (filgotinib) for rheumatoid arthritis (RA) may see its more targeted mechanism offer safety advantages for its Phase III FINCH 2 trial, though reservations linger after Eli Lilly’s (NYSE:LLY) Olumiant (baricitinib) setbacks, experts said. They remain upbeat on the janus kinase 1 (JAK1) inhibitor’s potential to provide strong efficacy based on previous signals and comparisons to Pfizer’s (NYSE:PFE) approved drug in the same class, Xeljanz (tofacitinib).

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Lilly’s Trulicity CVOT has experts optimistic based on past results but hesitant since not all prior GLP-1 CVOTs have shown benefit

Eli Lilly’s (NYSE:LLY) Trulicity (dulaglutide) for type 2 diabetes (T2D) has three experts cautiously optimistic over its potential to show benefit in its cardiovascular outcome trial (CVOT) while one declined to note expectations. Experts agreed that uncertainty prevails given the variation in past CVOT results for similar agents and the lack of clarity over the MOA for CV benefit.

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Novartis’s Phase III Kisqali MONALEESA-3 study will likely continue establishing efficacy, 1L randomized Faslodex combo data could provide a small but distinct advantage, experts say

Novartis’ (VTX:NOVN) Phase III MONALEESA-3 trial is rational in combining Kisqali (ribociclib) with AstraZeneca’s (LON:AZN) Faslodex (fulvestrant) in first- and second-line HR+Her2-negative advanced metastatic breast cancer due to Faslodex’s efficacy advantage over aromatase inhibitors (AIs) that are commonly used in first-line disease, experts said. They added the trial is expected to be a positive study.

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HBV functional cure likely to be triple combo, but no clear backbone; capsid target too crowded with other approaches showing potential, experts say

A hepatitis B virus (HBV) functional cure will likely be a triple therapy combination for most patients, but it is unclear which of the current investigated therapies are likely to have a pivotal backbone role, experts said.

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Alexion’s Soliris for neuromyelitis optica treads fine line for Phase III safety; common side effects of low concern, experts say

Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab) is under close scrutiny for meningococcal infection risk in its Phase III for neuromyelitis optica (NMO), experts said. Even a low incidence of meningococcal infection is going to impact its risk profile, they said, though noted other adverse events (AEs) seem acceptable.

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Jounce’s JTX-2011 has promising mechanism but experts highlight earliness of evidence to back clinical efficacy; combination elicits higher efficacy potential

Jounce Therapeutics’ (NASDAQ:JNCE) JTX-2011 mechanism as an inducible T-cell co-stimulator (ICOS) agonist holds promise to spur immune responses in gastric and breast cancer, experts said. However, the absence of validated clinical data draws pause on forecasting Phase I/II trial success, they noted.

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Genkyotex’s Phase II GKT831 trial has sound mechanism rationale though not specific to PBC; GGT primary endpoint lacks clinical relevance, experts say

Genkyotex’s (EPA:GKTX) Phase II trial investigating GKT831 for primary biliary cholangitis (PBC) has a positive mechanism rationale for efficacy as its antioxidant and anti-inflammatory effect may have an impact on fibrosis, experts said. However, this comes with the caveat that its targets NOX1/NOX4 are not directly linked to the disease, drawing some expert caution.

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J&J, Pfizer biosimilar payer policy case could survive motion to dismiss but proving anticompetitiveness remains challenging, experts say

Pfizer’s (NYSE:PFE) biosimilar antitrust claim against Johnson & Johnson (NYSE:JNJ) could be strong enough to reach the discovery stage of litigation but will survive only if the latter company's exclusionary tactics for Remicade (infliximab), beyond just lowered prices and bundling deals, are proven, said experts.

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Audentes Therapeutics’ AT132 Phase I/II ASPIRO trial in XLMTM will continue with low dose for next drug treatment cohort based on safety, efficacy signals, source says

Audentes Therapeutics (NASDAQ:BOLD) does not plan to increase the dose for its next drug treatment cohort in its Phase I/II ASPIRO trial of gene therapy AT132 against X-linked myotubular myopathy (XLMTM) despite the company saying otherwise, said a source familiar. Rather, due in part to a potentially worrisome safety signal, the company intends to keep dosing patients at the same level as announced in recent data, the source said.

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Blueprint’s BLU-285 mastocytosis ASH data promising, but KIT mutation-targeting knife may cut both ways – experts

Blueprint Medicines' (NASDAQ:BPMC) Phase I data for avapritinib in advanced systemic mastocytosis (SM) is praiseworthy but its advantageous target specificity could also engender resistance mutations down the line, experts said on the sidelines of the 2017 ASH meeting.

While the drug is seen as competitive to Novartis’ (VTX:NOVN) approved Rydapt (midostaurin), avapritinib’s greater specificity to KIT mutations – the driver mutation in SM – could also be a disadvantage with the resistance mutations having the potential to render the drug ineffective, experts said.

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