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PTI

Proteostasis

$4.35 /

+0.11 (+2.59%)

07:33
12/17/19
12/17
07:33
12/17/19
07:33

Proteostasis announces results from Phase 2 study of CFTR combinations

Proteostasis Therapeutics announced positive topline results from the Company's global, multicenter, randomized, placebo-controlled, 28-day, Phase 2 study evaluating its proprietary cystic fibrosis transmembrane conductance regulator, or CFTR, modulator combinations in F508del homozygous and heterozygous CF subjects 18 years of age and older. The trial is designed to assess the efficacy, safety and tolerability of PTI's once-daily proprietary combinations, 300 mg of dirocaftor, or PTI-808, and 600 mg of posenacaftor, or PTI-801, with or without 10 mg of nesolicaftor, or PTI-428, or placebo, over a four week treatment period. A total of 28 F508del homozygous and 40 F508del heterozygous subjects were enrolled into the doublet, triplet or placebo arms. The compounds were generally well tolerated and the majority of reported adverse events were mild to moderate in severity. Most subjects enrolled in the Phase 2 study carried a high disease burden, with over 80% of subjects trying and failing to enroll into trials of currently approved modulators due to ineligibility. Homozygous subjects receiving the triple combination experienced a mean absolute improvement in ppFEV1 of 8% over pooled placebo at day 28. Improvements in lung function were the highest in high disease burden subgroups, predefined as subjects with ppFEV1 less than70 at baseline. In PTI's first clinical study with F508del heterozygous population, 40 subjects with at least 26 different genotypes were enrolled. Based on these results, the Company is planning to launch a global, Phase 3, randomized, placebo-controlled, MORE trial in CF subjects with the common F508del homozygous mutation, beginning in 2020.

PTI Proteostasis
$4.35 /

+0.11 (+2.59%)

03/26/19 WBLR
William Blair upgrades Vertex to Outperform after 'subpar' competitor data
05/09/19 PIPR
Proteostasis price target lowered to $5 from $10 at Piper Jaffray
11/06/19 PIPR
Piper says Proteostasis guiding to TripleRx CF data sooner than expected
12/04/19 CANT
Proteostasis assumed with an Overweight at Cantor Fitzgerald

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Initiation
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General news
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General news
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Options
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