Sydnexis names long-time industry executive as new leader

Sydnexis, Inc. has selected pharma and biotech executive Perry J. Sternberg as CEO and the newest member of the company’s Board of Directors.

Refresh me on this company.

Launched in 2014 and based in San Diego, California, Sydnexis is a privately held, pre-commercial-stage biopharmaceutical company.

Its lead asset: SYD-101, a patented low-dose atropine sulfate ophthalmic solution intended to decrease pediatric myopia progression.

Clinical status: Currently in phase 3 clinical trials within the United States, Europe (partnered with Santen Pharmaceuticals), and China (planning stage for phase 3, per the company)
- Note: We’ll get to that phase 3 evaluation in a moment.

Now to Sternberg.

Sternberg is a 30-year veteran of the biotech and pharmaceutical industry with 15 years in eye care.

Most recently: He served as president and CEO of Corium, LLC, a commercial central nervous system (CNS) therapeutics company that has earned FDA approval and commercially launched two novel CNS therapies: AZSTARYS and ADLARITY.

Zeroing in on eye care: Sternberg previously worked at Novartis, Bausch + Lomb, and Shire US Inc.

His roles:
- Shire: Executive Vice President and Head of U.S. Commercial
- B+L: Vice President and General Manager, U.S. and Canada Pharmaceuticals
- Novartis: Head of Sales, Ophthalmology

Let’s get into specifics.

While at Shire, Sternberg served as lead on the build-out of the company’s ophthalmic business unit and the 2016 U.S. commercial launch of Xiidra (lifitegrast ophthalmic solution 5%).

The significance: Xiidra was FDA-approved as the first treatment for the signs and symptoms of dry eye disease (DED)
- Note: Xiidra was originally manufactured by Shire before being acquired by Novartis in 2019, followed by B+L just 4 years later, in September 2023

So why switch back to eye care?

According to Sternberg, pediatric myopia progression has a significant and growing unmet need—and, most notably, no FDA-approved pharmacological treatment options.

“I look forward to collaborating with this talented (Sydnexis) team to bring such an innovative treatment option like SYD-101 to pediatric patients, their families, and clinicians,” he stated.

According to Sydnexis Lead Board Director Jeffrey Weinhuff, Sternberg will be an asset to the company. “Perry has deep expertise in commercialization of new therapies across diverse markets and extensive experience leading organizational growth and transformation,” Weinhuff stated.

About this lead asset …

SYD-101 is currently undergoing clinical evaluation as two different dosage strengths in the 5-arm, multicenter, randomized, double-masked, placebo-controlled phase 3 STAR trial (NCT03918915).

The study is being conducted in two parts:

Part 1: Primary 3-year treatment period
- Participants receive one of three masked medications
  - Dosed as one drop at bedtime
Part 2: Randomized withdrawal period during year 1
- Participants originally receiving vehicle will receive SYD-101; participants originally receiving SYD-101 will receive either vehicle or SYD-101
  - Dosed as one drop at bedtime

Talk about these participants.

A total of 852 pediatric patients have been enrolled, aged 3 to 14.

Inclusion criteria:

Myopia of 0.5 D to 6.00 D in both eyes
Astigmatism ≤1.50 D in both eyes.
Anisometropia ≤1.00 D in both eyes.
See here for more, including exclusion criteria.

And what’s being measured?

Primary outcome: myopic progression > 0.75 D in participants, based on spherical equivalent (SE).

Time frame: Month 36

Also measured at Month 36, secondary outcomes include annual myopic progression as well as participants with an annual myopia progression rate of:

< = 0.50 D/year
< = 0.25 D/year
> = 0.50 D/year

See the complete list.

So … when can we expect data?

Per Clinical Trials, the STAR study is expected to conclude in June 2025 (with primary completion in June 2024).

Interim data will likely be released before then, though!

And lastly, when does Sternberg’s new role take effect?

August 5.