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Synlogic (Nasdaq: SYBX) shares are rallying premarket after the company reported positive data from clinical studies evaluating SYNB1618 and SYNB1934, investigational Synthetic Biotic medicines for the treatment of phenylketonuria (PKU).
In an interim analysis, the clinical-stage company said SYNB1618 demonstrated “clinically meaningful reductions of phenylalanine at several dose levels, across multiple time points.”
Meanwhile, SYNB1934, a strain evolved from SYNB1618, displayed two-fold higher activity than SYNB1618 in a head-to-head Phase 1 study in healthy volunteers.
The company now intends to incorporate SYNB1934 into part of the Phase 2 SynPheny-1 trial, with final results expected in H1 2022.
“Based on the favorable clinical data from the SYNB1618 and SYNB1934 programs available to date, the company intends to initiate planning for a pivotal Phase 3 study for the most promising strain,” Synlogic said in a statement.
Aoife Brennan, Synlogic's President and CEO, said: “The PKU program demonstrated clear proof of concept in this analysis, with SYNB1618 achieving a clinically meaningful reduction of phenylalanine in patients across multiple endpoints and time points.
“Additionally, our second PKU candidate SYNB1934 provides greater potency, which will allow us to optimize the clinical profile to address the profound needs of patients with PKU.”
Synlogic's share price is trading at $3.87 premarket, up 17.63% from Friday's close.
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