Mr. Fabio Chianelli reports

PHARMATHER BUILDS PORTFOLIO OF PERSONALIZED, 3D-PRINTED PEPTIDE PRODUCTS FOR NEW U.S. PEPTIDE PATHWAY, LED BY COLON-TARGETED KPV AND BPC-157

Pharmather Holdings Ltd. is building a portfolio of personalized peptide products for niche indications on its M3-DICINES 3-D-printed medicines platform, for near-term commercialization through the new United States peptide pathway. The first products are oral, colon-targeted KPV and BPC-157. They are being designed with the patent-pending COntRollable Release in 3-D printed Colonic Targeting (CORR3CT) technology of Craft Health Pte. Ltd. to carry the peptide through the stomach and release it in the colon-creating differentiated oral dosage forms for gastrointestinal applications where site-specific delivery may matter.

The timing is driven by a new United States Department of Health and Human Services (HHS) policy that creates a conditional pathway for qualified Section 503A pharmacies to compound six specified peptides; KPV and BPC-157 are the only two covered for oral use.

Pharmather's strategy is to develop personalized peptide products where formulation and delivery create a clear advantage, and to commercialize them with health care companies, telehealth platforms and pharmacies that already have patients, distribution and complementary peptide portfolios.

Key highlights

• Personalized peptide portfolio. Pharmather is building personalized peptide products for niche indications, starting with colon-targeted KPV and BPC-157, using pharmaceutical 3-D printing and proprietary drug-delivery technologies.
• New U.S. peptide pathway. A new HHS policy creates a conditional pathway for six specified peptides, with KPV and BPC-157 the only two covered for oral use.
• Differentiated colon delivery. CORR3CT is designed to carry a dose past the stomach and release it in the colon. In a peer-reviewed study using budesonide, CORR3CT delivered up to 75 per cent of the dose to the simulated colon, while the commercial comparator released more than 90 per cent before reaching it.
• Unmet need in large markets. Ulcerative colitis continues to have meaningful unmet needs, including patients who fail to achieve or sustain remission. Third-party estimates value the global IBD (irritable bowel disease) treatment market at $29.57-billion (U.S.) and the peptide therapeutics market at $140.9-billion (U.S.) in 2025.
• Partner of choice. Pharmather aims to be the development and manufacturing partner for health care companies, telehealth platforms and pharmacies that want to bring differentiated, personalized peptide products to market, whether or not they build pharmaceutical 3-D-printing capabilities in-house.

Building a personalized peptide portfolio

Pharmather believes the opportunity is not to sell undifferentiated, commodity peptide products, but to use pharmaceutical 3-D printing to create personalized and niche dosage forms that solve specific formulation and delivery challenges. The initial portfolio includes colon-targeted KPV and BPC-157 tablets and a BPC-157 chewable or orally disintegrating tablet designed for the upper gastrointestinal tract.

With CraftMake 3-D printer systems, peptide products are printed at room temperature without heat or UV, in patient-specific strengths from a validated digital recipe and in economical small batches. With PD Labs serving as Pharmather's U.S. Center of Excellence, the company intends to develop and operationalize these products in a real-world 503A pharmacy setting while building a repeatable model that may support future health care, telehealth and pharmacy partners.

Why colon-targeted KPV and BPC-157

KPV and BPC-157 are being studied for effects in the gastrointestinal tract, making targeted delivery relevant. KPV has demonstrated anti-inflammatory activity in mouse colitis models, including a colon-targeted study that achieved similar therapeutic efficacy at a 12,000-fold lower KPV concentration than free KPV. BPC-157 has limited early human ulcerative-colitis experience using rectal administration. The lead target is left-sided ulcerative colitis: about 30 to 60 per cent of patients with ulcerative colitis have inflammation in the descending colon, which most oral budesonide products are not designed to reach.

Neither KPV nor BPC-157 is Food and Drug Administration approved, but both can now be prescribed and compounded for oral use through the new U.S. pathway, subject to its conditions.

Differentiated colon delivery

CORR3CT is a 3-D-printed pill-in-pill tablet with a drug-loaded core inside a pH-responsive shell. The shell is designed to resist stomach acid and delay release until the lower intestine, with additional printed layers used to tune release toward the colon.

In the peer-reviewed 2023 in vitro study, CORR3CT tablets delivered up to 75 per cent of their budesonide dose to the simulated colon, while the commercial comparator released more than 90 per cent before reaching it. The study provides proof-of-concept for controllable colon targeting using 3-D printing. CORR3CT is also the subject of a published U.S. patent application assigned to Craft Health.

A new U.S. pathway for oral peptides

HHS's Enforcement Discretion Policy Regarding 503A compounding Using Certain Peptide Bulk Drug Substances is scheduled for publication in the federal register on Oct. 30, 2026. It covers BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. Of the six covered peptides, only KPV and BPC-157 are included for oral use.

The policy sets specific conditions, including qualifying peptide supply from an FDA-registered manufacturer with required documentation, patient-specific prescribing, serious adverse-event reporting and documentation of adequate human oral bioavailability for an oral formulation. Pharmather intends to design its products around these conditions, giving prescribers and pharmacies a documented, quality-controlled alternative to unregulated peptides.

Partnering with Pharmather

For health care companies with their own peptide concepts or existing peptide portfolios, Pharmather aims to be a development and technology partner-providing niche, differentiated peptide solutions that can complement existing portfolios without requiring partners to build specialized formulation and pharmaceutical 3-D-printing capabilities in-house. The M3-DICINES platform, built with Craft Health's technology, may also enable multipeptide products pursued through FDA approval pathways and colon-targeted versions of established gastrointestinal drugs.

Management commentary

"We are not trying to compete for patients with large telehealth brands that sell undifferentiated, commodity peptide products," said Fabio Chianelli, chairman and chief executive officer of Pharmather. "Our focus is the product itself -- building niche, personalized peptide solutions where formulation and delivery matter, starting with a colon-targeted strategy for KPV and BPC-157, made possible by our pharmaceutical 3-D-printing platform. We believe M3-DICINES can create value through Pharmather's own differentiated products and by helping health care partners add specialized peptide solutions to portfolios they already offer."

"We built CORR3CT to put a dose where the disease is," said Dr. Wei Jiang Goh, co-founder and chief executive officer of Craft Health. "CraftMake prints at room temperature without heat or UV, making it well suited to fragile molecules such as peptides. We look forward to supporting Pharmather's development of targeted oral KPV and BPC-157 products."

About Craft Health Pte. Ltd.

Craft Health is a Singapore-based pharmaceutical technology company founded in 2019 by pharmacists Dr. Wei Jiang Goh and Dr. Seng Han Lim. Its proprietary pharmaceutical 3-D printing platform includes the CraftMake printer, CraftControl software and CraftBlends formulations. Its heat- and UV-free semi-solid extrusion process is designed for compounding pharmacies, hospitals and pharmaceutical partners.

About Pharmather Holdings Ltd.

Pharmather Holdings is a specialty pharmaceutical and technology company advancing pharmaceutical 3-D printing for personalized medicine. Through its M3-DICINES platform and exclusive North American distribution of the CraftMake system, Pharmather is developing niche, differentiated products, and partner programs across peptides, rare-disease treatments and medical countermeasures.

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