SYBX - Synlogic gains after early Phase 2 data for phenylketonuria candidates

The clinical-stage biotech Synlogic, Inc. ( NASDAQ: SYBX ) jumped ~10% on Tuesday after the company reported top-line data from the Phase 2 trial for experimental oral drugs SYNB1934 and SYNB1618 in rare genetic condition phenylketonuria (PKU).

PKU is characterized by the accumulation of amino acid phenylalanine in the body to neurotoxic levels.

The trial named Synpheny-1 involved 20 adults with PKU, out of whom 11 were part of the SYNB1618 and nine enrolled in the SYNB1934 arm.

The company said that out of 10 patients who concluded the SYNB1618 arm and five who completed the SYNB1934 arm, 60% demonstrated a response defined as >20% reduction in Phe at either day seven or day 14.

Those who received SYNB1618 and SYNB1934 indicated 20% and 34% declines as mean change in fasting plasma Phe at Day 14 from baseline, respectively.

While all adverse events were mild or moderate, many were linked to gastrointestinal effects. However, three patients discontinued the trial due to GI-related issues.

One patient withdrew consent, and another withdrew, citing an adverse event of facial flushing linked to a possible allergic reaction, according to the company. Data are yet to undergo peer review.

Based on data, SYBX has selected SYNB1934 to study in a Phase 3 registrational study scheduled to start in H1 2023.

The readout has prompted Oppenheimer to raise the per-share target on SYBX to $8 from $6. “With all the usual caveats associated with small trials, we view the results as impressive, easily justifying Synlogic’s plans to advance ‘1934 into a pivotal study in 1H23,” the firm wrote.

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