Akari Therapeutics and Peak Bio Reveal Portfolio Prioritization for Merged Entity

Akari Therapeutics, Plc and Peak Bio Inc. have announced a joint portfolio prioritization review in light of their impending merger. The combined entity will emphasize Peak Bio’s ADC (antibody-drug conjugate) platform technology and Akari’s PAS-nomacopan development for Geographic Atrophy (GA), a severe eye condition.

The merger will see the combined company focusing on Peak Bio’s proprietary ADC technology, which involves the use of antibodies, linkers, and Peak Bio toxins for immune modulation. This technology includes a novel pre-clinical ADC candidate targeting TROP-2, a protein commonly found in several types of cancer. The strategy for this platform includes continuing IND (Investigational New Drug) enabling development and advancing novel toxins, such as their leading toxin, PH-1 (Thailanstatin). The company will also maintain business development activities due to significant market interest in ADC candidates.

On the other hand, Akari’s PAS-nomacopan is being developed for Geographic Atrophy (GA). It is a bispecific inhibitor targeting both complement and leukotriene B4, with an extended duration of action. Animal studies have shown sustained biological presence in the eye, indicating potential dosing every two to four months, which could offer a competitive advantage. PAS-nomacopan could provide safety and efficacy benefits over traditional complement inhibitors. The program will continue its IND enabling development, including full-scale drug manufacturing for clinical use, with a pre-IND meeting expected in the first half of 2024.

In addition to prioritizing these two core programs, the review has led to the suspension of Akari’s HSCT-TMA program. Enrollment in its active pediatric clinical study will be discontinued due to cost and timeline constraints. The combined company will work with the FDA to determine the best path forward for this technology and explore opportunities for partnership and licensing, particularly regarding the Priority Review Voucher (PRV).

Similarly, Peak Bio’s Phase II-ready PHP 303 program for Alpha 1 anti-trypsin deficiency (AATD), a rare orphan condition, will be discontinued. However, business development discussions around this technology will continue.

The merger, first announced on March 5, 2024, will combine Akari and Peak Bio as equals in an all-stock transaction. The new entity will operate under the name Akari Therapeutics, Plc and is expected to continue trading on the Nasdaq Capital Market as AKTX. The agreement stipulates that Peak stockholders will receive Akari ordinary shares, represented by American Depositary Shares, based on a specified exchange ratio. This exchange is projected to provide roughly equal equity ownership for Akari and Peak shareholders on a fully diluted basis, subject to adjustments based on net cash levels at the closing of the transaction. The merger is anticipated to close by the third quarter of this year, pending customary closing conditions, including shareholder approval.

Akari Therapeutics, listed on Nasdaq as AKTX, is a biotechnology company focused on developing treatments for autoimmune and inflammatory diseases, with its lead asset being the investigational drug nomacopan. Meanwhile, Peak Bio, which trades over-the-counter as PKBO, is a clinical-stage biopharmaceutical company that develops therapeutics for oncology and inflammation, featuring an ADC platform and a neutrophil elastase inhibitor ready for Phase II trials.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!