BREAKING Allysta advances ALY688 - first adiponectin receptor agonist in human testing TRIAL OASIS-1 Phase 2b/3 enrolled 922 dry eye patients FUNDING $20M Series A from Morningside Venture Investments PIPELINE Dry eye · NASH/MASH · Duchenne muscular dystrophy FOUNDED 2013 by Henry Hsu, MD PLATFORM Anti-inflammatory · anti-fibrotic · regenerative peptides
Allysta Pharmaceuticals logo
Clinical-Stage Biopharma Adiponectin Platform Rare Diseases

Allysta Pharmaceuticals

"Science driven. Results focused."

A private, venture-backed biopharmaceutical company building first-in-class peptides that switch on adiponectin signaling - the body's own protective cytokine - to fight inflammation, fibrosis and tissue damage across serious diseases.

Bellevue, Washington - The company logo photographed against Allysta's signature navy. Founded 2013 - clinical-stage - a six-person team running a near-1,000-patient trial.
2013
Founded
$20M
Series A Raised
922
OASIS-1 Patients
3+
Target Indications
The Company

One molecule, a big idea

What Allysta does

Most drug companies chase a symptom. Allysta chased a hormone. Adiponectin is one of the most abundant proteins circulating in human blood, and it quietly does something valuable: it dampens inflammation, resists fibrosis, and helps tissue repair itself. Biologists have called it a "protective" cytokine for exactly that reason.

The problem is that adiponectin is large, complex and unstable - a poor candidate for a conventional medicine. Allysta's answer is ALY688, a small engineered peptide that binds the adiponectin receptor and activates the same beneficial signaling pathways. The company describes it as the first adiponectin receptor agonist to enter human clinical testing.

Founded in 2013 by drug-development veteran Henry Hsu, MD, Allysta is a private, venture-backed, clinical-stage biopharmaceutical company focused on rare diseases with high unmet needs. Its thesis rests on decades of published adiponectin biology, with the innovation concentrated at the hard edge: turning that biology into a drug-like molecule.

Because adiponectin touches inflammation, fibrosis and regeneration all at once, a single agonist can be pointed at diseases that look unrelated on the surface - from a dry, inflamed eye to a scarring liver to a failing muscle.

"Adiponectin is a unique protective cytokine - reducing inflammation and fibrosis, and enhancing regeneration. ALY688 is the first adiponectin receptor agonist to enter human testing."

- Allysta Pharmaceuticals, on its lead program

Products & Services

The ALY688 family

One peptide, several formulations
2020 · OPHTHALMIC

ALY688 Ophthalmic Solution

A first-in-class peptide eye drop that reduces ocular surface inflammation and accelerates corneal re-epithelialization. Evaluated in the OASIS-1 Phase 2b/3 trial for moderate-to-severe dry eye disease.

2021 · SYSTEMIC

ALY688-SR / ALY688ER

A sustained/extended-release formulation for systemic use, targeting fibrotic and metabolic disease - including NASH/MASH and Duchenne muscular dystrophy.

2013 · PLATFORM

Adiponectin Agonist Platform

The underlying peptide chemistry: anti-inflammatory, anti-fibrotic, cell-regenerative and metabolic effects that can be directed at multiple disease areas from one core molecule.

Pipeline

Where ALY688 stands

Approximate development stage by indication
Dry Eye Disease - ALY688 OphthalmicPhase 2b/3 · OASIS-1
PreclinicalPhase 1Phase 2Phase 3
NASH / MASH - ALY688-SRPhase 1 / Preclinical
PreclinicalPhase 1Phase 2Phase 3
Duchenne Muscular Dystrophy - ALY688-SRPreclinical
PreclinicalPhase 1Phase 2Phase 3

Stages are approximate, based on publicly reported milestones; late-stage clinical results were not publicly confirmed at the time of writing.


The Market

The problems it takes on

Customers, competition, and fit

The problems it solves

Dry eye disease affects millions and is driven by inflammation and damage to the ocular surface. Fibrotic and metabolic diseases like NASH/MASH scar vital organs. Duchenne muscular dystrophy progressively destroys muscle through inflammation and fibrosis. Allysta's wager is that one underlying mechanism - restoring adiponectin signaling - can address the inflammation-and-fibrosis engine common to all three.

Who its customers are

As a pre-commercial, clinical-stage company, Allysta has no product buyers yet. Its ultimate beneficiaries are patients; its near-term stakeholders are clinical trial sites, investigators, investors, and potential pharmaceutical partners who could license or co-develop the programs.

How it is different

The differentiator is the target itself. Rather than competing on incremental improvements to known drug classes - the cyclosporine and lifitegrast eye drops in dry eye, or the crowded field of NASH candidates - Allysta pursues a first-in-class mechanism with no direct comparator. That is both the opportunity and the risk: first-in-class means no roadmap and no precedent for regulators.

Where it fits in the market

Allysta sits at the intersection of ophthalmology, metabolic disease and rare neuromuscular disease - unusual breadth for a six-person company. It occupies the niche of a lean, science-first developer advancing a platform asset, positioned to create value through clinical milestones and partnerships rather than building its own commercial engine.


Expertise

A small, senior team

The people behind the peptide
Henry Hsu, MDFounder & CEO

Extensive experience across all stages of drug development, from lead identification to Phase 3. Previously co-founded and led Altheos, raising over $32M to develop a ROCK inhibitor for glaucoma. MD from UCSF.

Ken Sall, MDMedical Head

Board-certified ophthalmologist directing clinical development of ALY688. Former Medical Director of the Sall Research Medical Center and principal investigator on 200+ clinical trials.

Kathryn Crawford, PhDVP, Head of Preclinical Development

25+ years in early-stage biotech and pharmaceutical development, with deep expertise in animal studies and disease models and 30+ peer-reviewed publications. PhD, Pharmacology, University of Wisconsin-Madison.

Melissa BlackHead of Program Management

Program management, strategic planning and partner management, with prior roles at Unity Biotechnology and Plexxikon.

Jeanette Stewart, RNHead of Clinical Operations

Three-plus decades managing clinical trials; co-founder and COO of the PRN Pharmaceutical Research Network, with 100+ scientific articles in ophthalmic research.


Business & Funding

How the company works

Capital-efficient, milestone-driven

Allysta runs the classic clinical-stage biopharma model: raise private capital, advance a proprietary asset through the clinic, and create value at milestones through partnership, licensing or acquisition rather than current product sales. Estimated annual revenue is minimal - the company is pre-commercial.

What stands out is capital efficiency. Allysta advanced a near-1,000-patient Phase 2b/3 trial on a $20M Series A with a team of roughly six. In a field where late-stage studies routinely burn nine figures, that discipline is a survival trait.

April 2019

$15M Series A

Preferred Series A financing led by Morningside Venture Investments to advance the ALY688 programs.

December 2019

+$5M Series A

Additional Series A financing from Morningside, bringing the total commitment to $20M.

Total

$20M raised

Single lead investor, Morningside - a focused, patient capital base for a rare-disease developer.

Milestones

The story so far

2013 to today
2013

Allysta founded

Henry Hsu, MD founds the company to develop first-in-class peptides targeting adiponectin signaling.

2019

$20M Series A from Morningside

$15M in April and $5M in December bring the Series A commitment to $20M.

2020

Positive early data

Positive Phase 1/2a dry eye results and preclinical NASH findings reported for ALY688.

2021

Late-stage programs begin

Dosing initiated in the OASIS-1 Phase 2b/3 dry eye trial; a Phase 1 study of ALY688-SR begins.

2022

OASIS-1 enrollment completed

Enrollment of 922 subjects completed in the Phase 2b/3 dry eye disease trial.


Questions

Frequently asked

The basics, answered
What does Allysta Pharmaceuticals do?

It is a clinical-stage biopharmaceutical company developing first-in-class peptide therapeutics that target adiponectin signaling - with anti-inflammatory, anti-fibrotic, regenerative and metabolic effects - for diseases such as dry eye, NASH/MASH and Duchenne muscular dystrophy.

What is ALY688?

ALY688 is Allysta's lead peptide, described as the first adiponectin receptor agonist to enter human testing. It is developed as an ophthalmic solution for dry eye and as a sustained/extended-release formulation (ALY688-SR / ALY688ER) for systemic conditions.

Who founded and leads Allysta?

Allysta was founded in 2013 by Henry Hsu, MD, who serves as Founder and CEO. He previously co-founded and led Altheos, developing a ROCK inhibitor for glaucoma.

How much funding has Allysta raised?

Allysta raised a $20M Series A from Morningside Venture Investments - $15M in April 2019 and an additional $5M in December 2019.

What is the OASIS-1 trial?

OASIS-1 is Allysta's randomized, double-masked, vehicle-controlled Phase 2b/3 trial evaluating ALY688 Ophthalmic Solution in moderate-to-severe dry eye disease; it enrolled 922 subjects.

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