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Lenz Therapeutics merges with Graphite Bio

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Four months after first entering into a definitive merger agreement, LENZ Therapeutics and Graphite Bio, Inc. have officially joined under one name.

Quick refresh on these players.

LENZ is a San Diego, California-based, late-stage biopharmaceutical company focused on developing and potentially commercializing innovative therapies to improve vision.

Their main focus: presbyopia via two potential investigational therapies.

Graphic Bio was a clinical-stage, next-generation gene editing company with a lead product candidate for sickle cell disease.

Now this merger.

As we previously reported, Graphite Bio entered into a subscription agreement for private investment in public equity (PIPE) financing ($53.5 million) at the close of the deal.

The price tag: Adding the PIPE financing proceeds and cash expected from both companies at closing, the deal was worth an estimated $225 million in cash or cash equivalents.

On top of that, Graphite Bio was expected to pay $115 million as well as a dividend to its shareholders (approximately $60 million) when the transaction closed.

Gotcha. So what is this new company’s focus on?

LENZ’s priorities include advancing its two presbyopia therapeutic candidates formulated as preservative-free, single-use, once-daily eye drops:

More about aceclidine: The small-molecule acetylcholine receptor agonist can cause miosis, which might result in a “pinhole” effect to improve near vision and prevent a myopic shift.

Any clinical data on these?

Positive topline data was reported from the phase 2 INSIGHT trial (NCT05294328), which evaluated both LNZ100 and LNZ101.

Each therapy met the primary endpoints of a 3-line or greater improvement in visual acuity (VA) without losing 1-line or more in distance VA at 1 hour:

  • LNZ100: 70% of treated patients (p<0.0001)
  • LNZ101: 56% of treated patients (p<0.0001)

Additionally, the formulations maintained an average pupil size of 1.5-2 mm for 10 hours, which was a biomarker of efficacy:

  • LNZ100: 37% of treated patients
  • LNZ101: 48% of treated patients

So what’s next for them?

Funny you should ask … A pivotal phase 3 CLARITY program was initiated in December 2022 following the INSIGHT 2 study completion.

The program involves a sequence of three double-masked, randomized, US-based, multi-center, safety/efficacy trials to further evaluate LNZ100 and LNZ101 for presbyopia:

  • CLARITY 1 for LNZ100 (NCT05656027)
    • Estimated completion: December 2023
  • CLARITY 2 safety study (NCT05753189)
    • Estimated completion: January 2024
  • CLARITY 3 for LNZ101 (NCT05728944)
    • Estimated completion: April 2024

And the outcome measures?

Per LENZ, the primary efficacy endpoints for both the CLARITY-1 and CLARITY-2 trials is the “percentage of participants who achieve 3-lines or greater improvement in near vision at 3 hours post-treatment” (instead of 1 hour, as in the INSIGHT trial) “compared to brimonidine and vehicle, respectively.”

For CLARITY-3, the main objective is to confirm “the long-term safety profile of LNZ100 and LNZ101 over a 6-month period.”

When is data expected?

Topline data from all three trials is expected in April 2024, according to LENZ. That data will also include the final determination of which candidate will be moving forward for a potential new drug application (NDA) submission to the FDA by mid-2024 for eventual market commercialization.

What else to know?

LENZ also announced its new executive leadership, which includes:

  • President / CEO: Eef Schimmelpennink
  • Chief Medical Officer: Marc Odrich, MD
  • Chief Commercial Officer Shawn Olsson
  • Chief Financial Officer: Dan Chevallard (effective March 21)