Nuformix has signed heads of terms to acquire Biovara, adding a clinical-stage lung cancer cough treatment to its respiratory drug development pipeline.

Proposed acquisition adds second respiratory drug programme

Nuformix has signed heads of terms to acquire UK pharmaceutical development company Biovara through a proposed share-for-share transaction.

The deal would bring together Nuformix’s NXP002 programme, targeting idiopathic pulmonary fibrosis (IPF), with Biovara’s LipAprep, a proprietary formulation of aprepitant being developed to treat lung cancer-related cough.

The proposed acquisition is intended to create a respiratory-focused pharmaceutical development company with two complementary programmes addressing different conditions.

LipAprep has completed a Phase 1 single-dose clinical study and is being prepared for further development, including a Phase 2 proof-of-concept study. NXP002 is an inhaled formulation of tranilast being developed for IPF and other fibrotic interstitial lung diseases.

Both programmes use established pharmaceutical compounds in proprietary formulations designed to improve their therapeutic potential in new indications.

Nuformix chairman Tim Metcalfe said: “We believe the proposed acquisition of Biovara represents an important strategic opportunity for Nuformix and its shareholders, bringing together two complementary respiratory drug development programmes to create a more substantial and diversified clinical-stage respiratory business with the potential to unlock significant shareholder value.”

LipAprep targets lung cancer-related cough

Biovara’s lead programme, LipAprep, is a lipid-based formulation of aprepitant, an established neurokinin-1 (NK-1) receptor antagonist used to prevent chemotherapy-induced nausea and vomiting.

The drug is being developed for persistent cough associated with lung cancer, a symptom that can affect patients’ quality of life through pain, fatigue and sleep disturbance.

Previous clinical research has indicated that aprepitant could reduce cough frequency in patients with lung cancer.

In one randomised, double-blind, placebo-controlled study, short-term treatment was associated with a 30.3% mean reduction in 24-hour cough frequency compared with placebo. The study also reported improvements in patient-reported cough outcomes.

A separate randomised study involving 128 patients found improvements in cough severity and cough-specific quality of life when aprepitant was added to usual antitussive treatment for seven days.

However, the existing formulation has pharmacokinetic limitations that could make long-term treatment challenging.

LipAprep has been developed using a proprietary lipid formulation intended to provide more predictable drug exposure and support chronic administration. Its patent protection extends to at least 2045.

The completed Phase 1 single-ascending-dose study included doses of up to 750mg. Biovara is now preparing for further clinical development, including multiple-dose optimisation and a Phase 2 proof-of-concept study in patients with lung cancer-related cough.

Nuformix executive director Dan Gooding said: “What particularly interests us about LipAprep is the strength of the clinical rationale. In a controlled clinical study, aprepitant reduced 24-hour cough frequency by over 30% versus placebo after just three days at the standard antiemetic dose.”

NXP002 continues development for pulmonary fibrosis

Nuformix’s NXP002 programme uses an inhaled formulation of tranilast, an established drug being repurposed for IPF, progressive pulmonary fibrosis and other fibrotic interstitial lung diseases.

The formulation is designed to deliver tranilast directly to the lungs, potentially achieving relevant local drug concentrations while limiting systemic exposure.

According to Nuformix, preclinical studies have demonstrated anti-fibrotic and anti-inflammatory activity in human IPF lung tissue. Further inhaled studies have indicated modulation of the TGF-β/SMAD signalling pathway, which is involved in fibrosis.

NXP002 has received Orphan Drug Designation for IPF from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Nuformix intends to continue seeking a licensing or development partnership for NXP002, with discussions involving potential commercial partners remaining ongoing.

Gooding added: “Equally, NXP002 remains a highly differentiated opportunity, with encouraging results in human IPF lung tissue, recent in-vivo evidence of fibrosis-relevant pathway engagement and a substantial historical clinical evidence base for tranilast, including findings consistent with fibrosis resolution and restoration of tissue function.”

Acquisition remains subject to due diligence

The proposed transaction is envisaged as a merger of equals, with Nuformix issuing new ordinary shares in exchange for Biovara’s entire issued and to be issued share capital.

The combined valuation has yet to be agreed. Completion remains conditional on satisfactory due diligence, definitive transaction documentation and the necessary regulatory and shareholder approvals.

The heads of terms include a six-month exclusivity period and a transaction long-stop date of 30 April 2027.

Nuformix also intends to cancel its existing Main Market listing and seek admission of the enlarged group’s shares to AIM, subject to the required approvals.

The proposed acquisition may constitute a reverse takeover under UK Listing Rules. There is no certainty that the transaction will proceed or that its final terms will remain as currently envisaged.

Nuformix has appointed SP Angel Corporate Finance as financial adviser in connection with the proposed acquisition and AIM admission.