Pharma Two B

Pharma Two B focuses on developing innovative combination drugs for neurological disorders, with a particular emphasis on Parkinson's disease (PD). Pharma Two B's lead product candidate is P2B001, a novel fixed-dose combination of extended-release formulations of low-dose pramipexole (0.6 mg) and rasagiline (0.75 mg) in a single once-daily pill. P2B001 is being developed as a potential first-line therapy for people with early-stage Parkinson's disease.

In a Phase 3 clinical trial completed in 2022, P2B001 demonstrated comparable efficacy to optimally titrated, marketed extended-release pramipexole in improving motor symptoms and activities of daily living in early PD patients. However, P2B001 showed a significantly lower incidence of excessive daytime sleepiness and fewer dopaminergic side effects compared to higher doses of pramipexole. The drug does not require dose titration, which may offer advantages in terms of convenience and tolerability. Pharma Two B owns worldwide patents for P2B001's pharmaceutical composition and method of treatment, which are expected to remain in force until January 2033.

As of September 2024, Pharma Two B was preparing to submit a New Drug Application (NDA) for P2B001 to the US Food and Drug Administration, with the submission planned for the first half of 2026. The company aims to utilize the FDA's 505(b)(2) regulatory approval pathway for P2B001, which may allow for a more streamlined development process based on previously approved drugs.

Key customers and partnerships

In July 2024, Pharma Two B announced plans to merge with Hepion Pharmaceuticals, Inc., a US-based clinical-stage biopharmaceutical company. The proposed merger would result in Pharma Two B becoming a publicly traded company on the Nasdaq stock exchange under the ticker symbol "PHTB". As part of this transaction, Pharma Two B entered into an agreement for an USD 11.5 million private placement with a syndicate of new and existing institutional life science investors. The merger is expected to provide Pharma Two B with additional resources to advance the development and potential commercialization of P2B001.