17 June 2021 - - US-based biopharmaceutical company Lenz Therapeutics has emerged from stealth mode with a USD 47m series A financing from Versant Ventures and RA Capital Management, the company said.

Proceeds from the financing will be utilized to progress the company's lead asset, an eyedrop formulation of aceclidine, towards an NDA submission for the treatment of presbyopia.

Presbyopia impacts more than 120 m people in the US and almost two bn people globally, and is commonly viewed as the largest ophthalmology market with no current pharmaceutical solutions available to offer to patients.

Currently the available choices are reading glasses, which are viewed by many patients as very undesirable, or irreversible invasive surgical procedures that have inherent risks.

As a result, there is high interest from patients in an effective and safe pharmaceutical option.
Lenz Therapeutics (formerly Presbyopia Therapies) is developing a proprietary eye drop formulation of aceclidine.

Aceclidine is an NCE in the US and has an established safety profile from its prior use in Europe for glaucoma.

In a 58-patient Phase II trial the molecule met the primary endpoints, showing significant rapid and long-lasting improvements in near vision.

Within 30 minutes, 53% of patients showed three lines or more of reading improvement and 81% showed two lines or more.

Effects were significant up to seven hours, the last measured time point. Importantly, there was no loss in distance vision under normal and low luminance conditions and the product was well tolerated with no serious adverse events.

Schimmelpennink brings a proven track record in successfully building and scaling biopharmaceutical companies.

Previously, he was CEO of Pfenex Inc., which was acquired by Ligand Pharmaceuticals Inc. (NASDAQ: LGND) last year for USD 516m.

Before Pfenex, Schimmelpennink was CEO of Alvotech, where he led the company through a critical growth phase, and aligned R and D, manufacturing and commercial capabilities across a portfolio of monoclonal antibodies.

Prior to that he held senior positions at Pfizer and Hospira within their global specialty injectables businesses.

Aceclidine is a small molecule acetylcholinesterase receptor agonist that causes pupil contraction, or miosis, creating a pinhole effect that improves near vision.

Studies have shown that aceclidine's mechanism of action is differentiated from competing therapeutic options due to its ability to create a pinhole pupil effect while avoiding myopic shift. It is crucial to minimize myopic shift as it can significantly impair distance vision for a majority of presbyopes.

Aceclidine's unique MOA, in which miosis is decoupled from myopic shift, is expected to allow it to target the broadest patient population.

In the Phase II trial, the near vision improvement was due to aceclidine's ability to maintain a pinhole pupil sweet spot of 1.5 mm to 2 mm for seven hours.

There was no loss and a slight trend toward net gain in best corrected distance vision. In addition, aceclidine was well tolerated with most common side effect being mild discomfort on instillation and no serious adverse events.

The company plans to use proceeds from its USD 47m series A financing to progress aceclidine towards an NDA submission.

Lenz Therapeutics also is positioned to build and advance a pipeline of therapeutic options for patients in the ophthalmology space.

Lenz Therapeutics is a late-stage clinical company developing innovative ophthalmic pharmaceutical products that improve vision. Its lead program, aceclidine, is an eye drop designed to restore the loss of near vision associated with presbyopia.