Puretech Health Stock Price, News & Analysis

PureTech Health announced positive results from the ELEVATE IPF Phase 2b trial evaluating deupirfenidone for idiopathic pulmonary fibrosis (IPF). The trial achieved its primary and key secondary endpoints with a 98.5% probability of superiority over placebo in slowing lung function decline.

The higher dose of deupirfenidone (825 mg TID) showed an 80.9% treatment effect versus placebo (-21.5 mL vs. -112.5 mL decline), significantly outperforming pirfenidone's 54.1% effect (-51.6 mL vs. -112.5 mL). Both doses demonstrated favorable tolerability with comparable gastrointestinal adverse events to pirfenidone.

Over 90% of trial completers opted to enroll in the ongoing open-label extension study, with the longest treatment duration reaching 79-81 weeks.

Seaport Therapeutics, a PureTech Founded Entity, presented additional data from its Phase 1 study of SPT-300 at the ACNP Annual Meeting 2024. The study, involving 99 participants, evaluated an oral prodrug of allopregnanolone designed for treating major depressive disorder. Key findings showed SPT-300 was well-tolerated with mild to moderate adverse effects, achieving blood levels up to nine times greater than unmodified allopregnanolone. The drug demonstrated pharmacodynamic activity through EEG and VOG assessments, with effects peaking at 4 hours post-dose and diminishing within 6-8 hours. Based on these results, SPT-300 is deemed suitable for chronic, nightly dosing in a planned Phase 2b placebo-controlled study.

PureTech Health presented data from its Phase 1b trial of LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for treating relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) at the 2024 ASH Annual Meeting.

The trial evaluated LYT-200 both as monotherapy and in combination with venetoclax and hypomethylating agents. In monotherapy, 59% of 22 evaluable patients achieved stable disease or better, with two partial responses. In combination therapy, 80% of 15 evaluable patients achieved stable disease or better, including two complete responses.

The treatment showed a favorable safety profile across all dose levels with no dose-limiting toxicities. The mean duration of treatment exceeded two months in both arms, surpassing the standard survival rate for venetoclax/HMA-refractory patients.

PureTech Health (Nasdaq: PRTC) announced that its Founded Entity, Seaport Therapeutics, has appointed Sandi Peterson to its Board of Directors. Peterson, currently Lead Independent Director at Microsoft and Operating Partner at Clayton, Dubilier & Rice, brings significant experience from her previous role as Group Worldwide Chair at Johnson & Johnson. Her appointment strengthens Seaport's leadership as the company advances its development of novel neuropsychiatric medicines. Peterson's extensive background includes executive positions at Bayer, Medco Health Solutions, and Nabisco, with recognition from Fortune Magazine's Most Powerful Women in Business list.

PureTech Health (Nasdaq: PRTC, LSE: PRTC), a clinical-stage biotherapeutics company, has announced its management team's participation in two upcoming investor conferences. Bharatt Chowrira, CEO, and Eric Elenko, Co-founder and President, will present at the UBS Global Healthcare Conference on November 13, 2024, at 8:45 a.m. PST, and the Jefferies London Healthcare Conference on November 19, 2024, at 2:30 p.m. GMT. Webcasts of both presentations will be accessible through PureTech's investor relations website.

PureTech Health's Founded Entity, Seaport Therapeutics, has closed an oversubscribed $225 million Series B financing round, bringing its total capital raised to $325 million since its launch in April 2024. The round was led by General Atlantic, with participation from various top-tier investors and founding investors.

Seaport will use the proceeds to advance its clinical-stage pipeline of neuropsychiatric medicines and further develop its Glyph™ technology platform. The platform is designed to enhance oral bioavailability and reduce side effects of clinically active drugs. PureTech will hold a 36.7% equity ownership in Seaport on a diluted basis following the financing.

Seaport's pipeline includes SPT-300 for major depressive disorder, SPT-320 for generalized anxiety disorder, and SPT-348 for mood and other neuropsychiatric disorders. The company aims to deliver novel therapeutics for patients suffering from depression, anxiety, and other neuropsychiatric disorders.

PureTech Health presented research on idiopathic pulmonary fibrosis (IPF) and its clinical trial strategy for LYT-100 (deupirfenidone) at the CHEST 2024 Annual Meeting. The company shared insights from a 90-person IPF patient survey, highlighting the high disease burden and gaps in symptom management. Key findings include:

- 86% experience shortness of breath
- 78% report fatigue
- 77% suffer from cough
- Differences in care between ILD centers and community pulmonary practices

PureTech also presented its plan to use a Bayesian approach in evaluating the Phase 2b ELEVATE IPF trial of LYT-100. This method aims to enhance statistical power and reduce placebo group size. Topline results from the trial are expected by the end of 2024.

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) announced its participation in the CHEST 2024 Annual Meeting in Boston from October 6-9. The company will present three studies related to LYT-100 (deupirfenidone) for treating idiopathic pulmonary fibrosis (IPF). These presentations will inform clinical, commercial, and patient engagement strategies for LYT-100.

Key points:

• Topline data from the Phase 2b ELEVATE IPF trial of LYT-100 is expected by the end of 2024
• A streamlined development program is planned, potentially advancing to Phase 3 pending positive outcomes and regulatory feedback
• PureTech believes successful Phase 2b and Phase 3 trials could support registration in the U.S. and other regions

The presentations will cover patient experiences at ILD centers vs. community practices, the ongoing burden of IPF in the antifibrotic era, and a Bayesian approach for the ELEVATE IPF trial.

PureTech Health announced that KarXT, now marketed as Cobenfy, has received FDA approval for treating schizophrenia in adults. This milestone triggers $29 million in payments to PureTech and unlocks potential future payments and royalties. Cobenfy, invented by PureTech, is the first new drug mechanism approved in over 50 years for schizophrenia treatment.

The approval validates PureTech's unique R&D model, which has now produced three FDA-approved therapeutics. PureTech has generated approximately $1.1 billion from its involvement with Karuna Therapeutics, which was recently acquired by Bristol Myers Squibb. This success enables PureTech to self-fund the advancement of several programs, including LYT-100 for idiopathic pulmonary fibrosis, with topline data expected by year-end.